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Endoscopic nasobiliary drainage versus endoscopic biliary stenting for preoperative biliary drainage in patients with malignant hilar biliary obstruction: Propensity score‐matched multicenter comparative study
Abstract
Objectives
For preoperative biliary drainage (PBD) of malignant hilar biliary obstruction (MHBO), current guidelines recommend endoscopic nasobiliary drainage (ENBD) due to the higher risk of cholangitis after endoscopic biliary stenting (EBS) during the waiting period before surgery. However, few studies have supported this finding. Therefore, we aimed to compare the outcomes of preoperative ENBD and EBS in patients with MHBO.
Methods
Patients with MHBO who underwent laparotomy for radical surgery after ENBD or EBS were included from retrospectively collected data from 13 centers (January 2014 to December 2018). We performed a 1:1 propensity score matching between the ENBD and EBS groups. These patients were compared for the following: cholangitis and all adverse events (AEs) after endoscopic biliary drainage (EBD) until surgery, time to cholangitis development after EBD, post‐surgical AEs, and in‐hospital death after surgery.
Results
Of the 414 patients identified, 355 were analyzed in this study (226 for ENBD and 129 for EBS). The matched cohort included 63 patients from each group. The proportion of cholangitis after EBD was similar between the two groups (20.6% vs. 25.4%, p = 0.67), and no significant difference was observed in the time to cholangitis development. The proportions of surgical site infections, bile leaks, and in‐hospital mortality rates were similar between the groups.
Conclusions
For PBD of MHBO, the proportion of AEs, including cholangitis, after EBD until surgery was similar when either ENBD or EBS was used.
The purpose of preoperative biliary drainage (PBD) is to reduce complications during the perioperative period. The extrahepatic bile duct comprises distal and hilar bile ducts and assessing the need for PBD must be considered separately for each duct, as surgical procedures and morbidities vary. The representative disease‐causing distal bile duct obstruction is pancreatic cancer. A randomized controlled trial has revealed that PBD carries the risk of recurrent cholangitis and pancreatitis before surgery, thus eliminating the need for PBD when early surgery is feasible. However, neoadjuvant therapy has seen a rise in recent years, resulting in longer preoperative waiting periods and an increased demand for PBD. In such cases, metal stents are preferable to plastic stents due to their lower stent occlusion rates. When endoscopic transpapillary biliary drainage (EBD) is not viable, endoscopic ultrasound‐guided biliary drainage may be a suitable substitute. In the hilar bile duct, the representative disease‐causing obstruction is hilar cholangiocarcinoma. PBD's necessity has long been a subject of contention. In spite of earlier criticisms of routine PBD, recent views have emerged recommending PBD, particularly when major hepatectomy is required, to prevent postoperative liver failure. Given the risk of tumor seeding associated with percutaneous transhepatic biliary drainage, EBD is preferable. Nevertheless, as its shortcomings involve recurrent cholangitis until surgery due to stent or tube obstruction, it is necessary to seek out novel approaches to circumvent complications. In this review we summarize the current evidence for PBD in patients with distal and hilar biliary obstruction.
Background
The appropriate method of preoperative endoscopic biliary drainage (EBD) for cholangiocarcinoma with hilar biliary obstruction remains controversial. The inside-stent technique is a method of placing plastic stents entirely inside the bile duct. Several studies of patients with unresectable stage have reported longer stent patency compared with conventional endoscopic biliary stenting (EBS). Inside-stent techniques have been introduced as a bridge-to-surgery option and as an alternative to conventional EBS.
Aims
We aimed to evaluate the clinical outcomes of inside stent use and conventional EBS.
Methods
During this retrospective multicenter study, we reviewed consecutive patients with cholangiocarcinoma who underwent radical surgery after conventional EBS or inside-stent insertion. Adverse event (AE) rates after EBD and post-surgical AEs were compared. A multivariable analysis was performed to identify factors affecting cholangitis after EBD.
Results
Conventional EBS and inside-stent procedures were performed for 56 and 73 patients, respectively. Patient backgrounds were similar between groups, except for percutaneous transhepatic portal vein embolization. The waiting time before surgery was similar between groups (28.5 days vs. 30 days). There were no significant differences in the cholangitis rate (21.4% vs. 26.0%; P = 0.68) and all AEs (25.0% vs. 30.1%; P = 0.56) between groups. The post-surgical AE rate was similar between the groups. The multivariable analysis found that preprocedural cholangitis was a risk factor for cholangitis after EBD (odds ratio: 5.67; 95% confidence interval: 1.61–19.9).
Conclusions
The outcomes of inside-stent techniques and conventional EBS for the management of preoperative EBD are comparable for patients with cholangiocarcinoma.
Background:
Endoscopic biliary stent placement is the standard of care for biliary strictures, but stents across the papilla are prone to duodenobiliary reflux, which can cause stent occlusion. Preliminary studies of "inside stents" placed above the papilla showed encouraging outcomes, but prospective data with a large cohort were not reported.
Methods:
This was a prospective multicenter registry of commercially available inside stents for benign and malignant biliary strictures. Primary endpoint was recurrent biliary obstruction (RBO). Secondary endpoints were technical success of stent placement and removal, adverse events, and stricture resolution.
Results:
A total of 209 inside stents were placed in 132 (51 benign and 81 malignant) cases with biliary strictures in 10 Japanese centers. During the follow-up period of 8.4 months, RBO was observed in 19% of benign strictures. The RBO rate was 49% in malignant strictures, with the median time to RBO of 4.7 months. Technical success rates of stent placement and removal were both 100%. The adverse event rate was 8%.
Conclusion:
This prospective multicenter study demonstrated that inside stents above the papilla were feasible in malignant and benign biliary strictures, but a randomized controlled trial is warranted to confirm its superiority to conventional stents across the papilla.
Background
The Japanese Society of Hepato‐Biliary‐Pancreatic Surgery launched the clinical practice guidelines for the management of biliary tract cancers (cholangiocarcinoma, gallbladder cancer, and ampullary cancer) in 2007, then published the 2nd version in 2014.
Methods
In this 3rd version, clinical questions (CQs) were proposed in six topics. The recommendation, grade for recommendation, and statement for each CQ were discussed and finalized by an evidence‐based approach. Recommendations were graded as Grade 1 (strong) or Grade 2 (weak) according to the concepts of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system.
Results
The 31 CQs covered the six topics: 1) prophylactic treatment, 2) diagnosis, 3) biliary drainage, 4) surgical treatment, 5) chemotherapy, and 6) radiation therapy. In the 31 CQs, 14 recommendations were rated strong and 14 recommendations weak. The remaining 3 CQs had no recommendation. Each CQ includes a statement of how the recommendations were graded.
Conclusions
This latest guideline provides recommendations for important clinical aspects based on evidence. Future collaboration with the cancer registry will be key for assessing the guidelines and establishing new evidence.
Background/aims:
The aim of this study was to evaluate outcomes of inside plastic stents (iPSs) versus those of metal stents (MSs) for treating unresectable perihilar malignant obstructions.
Methods:
For all patients who underwent endoscopic suprapapillary placement of iPS(s) or MS(s) as the first permanent biliary drainage for unresectable malignant perihilar obstructions between January 2014 and August 2019, clinical outcomes using iPSs (n=20) and MSs (n=85), including clinical efficacy, adverse events, and time to recurrence of biliary obstruction (RBO), were retrospectively evaluated.
Results:
There were no differences in clinical effectiveness (95% for the iPS group vs. 92% for the MS group, p=1.00). Procedure-related adverse events, including pancreatitis, acute cholangitis, acute cholecystitis, and death, were observed for 8% of the MS group, although no patient in the iPS group developed such adverse events. The median time to RBO was 561 days (95% confidence interval, 0-1,186 days) for iPSs and 209 days (127-291 days) for MSs, showing a significant difference (p=0.008).
Conclusions:
s Time to RBO after iPS placement was significantly longer than that after MS placement. IPSs, which are removable, unlike MSs, were an acceptable option.
Although the diagnostic and severity grading criteria on the 2013 Tokyo Guidelines (TG13) are used worldwide as the primary standard for management of acute cholangitis (AC), they need to be validated through implementation and assessment in actual clinical practice. Here, we conduct a systematic review of the literature to validate the TG13 diagnostic and severity grading criteria for AC and propose TG18 criteria. While there is little evidence evaluating the TG13 criteria, they were validated through a large-scale case series study in Japan and Taiwan. Analyzing big data from this study confirmed that the diagnostic rate of acute cholangitis based on the TG13 diagnostic criteria was higher than that based on the TG07 criteria, and that 30-day mortality in patients with a higher severity based on the TG13 severity grading criteria was significantly higher. Furthermore, a comparison of patients treated with early or urgent biliary drainage versus patients not treated this way showed no difference in 30-day mortality among patients with Grade I or Grade III AC, but significantly lower 30-day mortality in patients with Grade II AC who were treated with early or urgent biliary drainage. This suggests that the TG13 severity grading criteria can be used to identify Grade II patients whose prognoses may be improved through biliary drainage. The TG13 severity grading criteria may therefore be useful as an indicator for biliary drainage as well as a predictive factor when assessing the patient's prognosis. The TG13 diagnostic and severity grading criteria for AC can provide results quickly, are minimally invasive for the patients, and are inexpensive. We recommend that the TG13 criteria be adopted in the TG18 guidelines and used as standard practice in the clinical setting.
Summary background data
Operative treatment combined with PBD has been established as a safe management strategy for Klatskin tumors. However, controversy exists regarding the preferred technique for PBD among percutaneous transhepatic biliary drainage (PTBD), endoscopic biliary stenting (EBS), and endoscopic nasobiliary drainage (ENBD). This study aimed to identify the best technique for preoperative biliary drainage (PBD) in Klatskin tumor patients.
Methods
This study evaluated 98 Klatskin tumor patients who underwent PBD prior to operation with a curative aim between 2005 and 2012. The PTBD, EBS, and ENBD groups included 43, 42, and 13 patients, respectively. Baseline characteristics, technical success rate, complications of PBD, and surgical outcomes were compared.
Results
Initial technical success rates (97.3 %, PTBD; 90.2 %, endoscopic methods, including EBS and ENBD) and mean duration until biliary decompression (31.0, PTBD; 28.7, EBS; 35.8 days, ENBD) were not significantly different between the groups. Total frequency of complications did not significantly differ between the EBS group (42.9 %) and the PTBD (27.9 %, p = 0.149) and ENBD (15.4 %, p = 0.072) groups. The ENBD group showed a significantly higher rate of conversion to other methods (76.9 %) than the PTBD (4.7 %, p < 0.0001) and EBS (35.7 %, p = 0.009) groups.
Conclusions
PTBD, EBS, and ENBD showed comparable results regarding initial technical success rates, complication rates, and surgical outcomes. As Klatskin tumor patients must undergo PBD prior to 3 weeks before surgery, PTBD and ENBD are uncomfortable and disadvantageous in terms of compliance. EBS was the most suitable method for initial PBD in terms of compliance among Klatskin tumor patients.
Background and study aims:
Neoadjuvant chemotherapy (NAC) may lead to a successful margin-negative resection in patients with initially unresectable locally advanced Klatskin tumor (IULAKT). Use of removable plastic stents is preferable for the safe implementation of NAC in patients with IULAKT to reduce the risk of recurrent cholangitis. Our aim was to evaluate the efficacy associated with the use of plastic stents placed across the stenosis and above the papilla (above stent) during NAC.
Patients and methods:
In this study, we stratified the patients into two groups chronologically with respect to the period of stent placement: above stent group (n = 17) and across stent group (n = 23) (plastic stent across the sphincter of Oddi).
Results:
The median stent patency period was 99 days in the above stent group and 31 days in the across stent group (P < 0.0001). The number of stents (P = 0.017) and the rate of emerging undrained cholangitis areas (P = 0.025) were significantly reduced in the above stent group than the counterpart. Regarding time to recurrent biliary obstruction, the above stent group had a longer duration than the across stent group (log rank test, P = 0.004). Length of hospital stay was significantly shorter for the above stent group than the across stent group (P = 0.0475). Multivariate analysis revealed that above stent placement (odds ratio = 33.638, P = 0.0048) was significantly associated with stent patency over a period of 90 days.
Conclusions:
Above stent placement should be considered for the relief of biliary obstruction and potentially reduces the cost for patients with IULAKT scheduled to receive NAC.
Background
Endoscopic biliary stenting (EBS) is one of the most important palliative treatments for biliary tract cancer. However, reflux cholangitis arising from bacterial adherence to the inner wall of the stent must be avoided. We evaluated the use of EBS above the sphincter of Oddi to determine whether reflux cholangitis could be prevented in preoperative cases.Methods
Fifty-seven patients with primary biliary tract cancer were retrospectively recruited for the evaluation of stent placement either above (n =25; inside stent group) or across (n =32; conventional stent group) the sphincter of Oddi. We compared the stent patency periods prior to the time of surgical resection.ResultsThe preoperative periods were 96.3 days in the conventional stent group and 96.8 days in the inside stent group (P =0.979). Obstructive jaundice and/or acute cholangitis occurred in 7 patients (28.0%) in the inside stent group and in 15 patients (46.9%) in the conventional stent group during the preoperative period (P =0.150). The average patency periods of the stents were 85.2 days (range, 13¿387 days) for the inside stent group and 49.1 days (range, 9¿136 days) for the conventional stent group (log-rank test: P =0.009). The mean numbers of re-interventions because of stent occlusion were 0.32 for the inside stent group and 1.03 for the conventional stent group (P =0.026). Post-endoscopic retrograde cholangiopancreatography complications occurred in 2 patients in the inside stent group and 4 patients in the conventional stent group (P =0.516). Postoperative liver abscess occurred in 1 patient in the inside stent group and 5 patients in the conventional stent group (P =0.968). Inside stent placement was the only significant preventative factor associated with stent obstruction based on univariate (hazard ratio [HR], 0.286; 95% confidence interval [CI], 0.114-0.719; P =0.008) and multivariate (HR, 0.292; 95% CI, 0.114-0.750; P =0.011) analyses.Conclusion
Temporary plastic stent placement above the sphincter of Oddi is a better bridging treatment than conventional stent placement in preoperative primary biliary tract cancer.
Evaluation of indeterminate biliary strictures typically involves collection and analysis of tissue or cells. Brush cytology and intraductal biopsies that are routinely performed during ERCP to assess malignant-appearing biliary strictures are limited by relatively low sensitivity.
To study the comparative effectiveness of brushings for cytology and intraductal biopsies in the etiology of biliary strictures.
Meta-analysis.
Referral center.
PUBMED and Embase databases were reviewed for studies published to April 2014 where diagnostic correlation of histology was available.
Database and review of study findings.
Sensitivity and specificity.
The pooled sensitivity and specificity of brushings for the diagnosis of malignant biliary strictures was 45% (95% confidence interval [CI], 40%-50%) and 99% (95% CI, 98%-100%), respectively. The pooled diagnostic odds ratio to detect malignant biliary strictures was 33.43 (95% CI, 14.29-78.24). For intraductal biopsies, the pooled sensitivity and specificity were 48.1% (95% CI, 42.8%-53.4%) and 99.2% (95% CI, 97.6%-99.8%), respectively. The pooled diagnostic odds ratio to detect malignant biliary strictures was 43.18 (95% CI, 19.39-95.83). A combination of both modalities only modestly increased the sensitivity (59.4%; 95% CI, 53.7%-64.8%) with a specificity of 100% (95% CI, 98.8%-100.0%). The Begg-Mazumdar and Egger tests indicated a low potential for publication bias.
Inclusion of low-quality studies.
Our study suggests that both brushings and biopsy are comparable and have limited sensitivity for the diagnosis of malignant biliary strictures. A combination of both only modestly increases the sensitivity.
Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.
Due to advances in endoscopic equipment and techniques, preoperative endoscopic biliary drainage (EBD) has been developed to serve as an alternative to percutaneous transhepatic biliary drainage (PTBD). This study sought to clarify the benefit of EBD in comparison to PTBD in patients who underwent radical resections of hilar cholangiocarcinoma. One hundred and forty-one patients underwent radical surgery for hilar cholangiocarcinoma between 2000 and 2008 were retrospectively divided into two groups based on the type of preoperative biliary drainage, PTBD (n = 67) or EBD (n = 74). We investigated if the different biliary drainage methods affected postoperative survival and mode of recurrence after median observation period of 82 months. The survival rate for patients who underwent EBD was significantly higher than those who had PTBD (P = 0.004). Multivariate analysis revealed that PTBD was one of the independent factors predictive of poor survival (hazard ratio: 2.075, P = 0.003). Patients with PTBD more frequently developed peritoneal seeding in comparison to those who underwent EBD (P = 0.0003). PTBD was the only independent factor predictive of peritoneal seeding. In conclusion, EBD might confer an improved prognosis over PTBD due to prevention of peritoneal seeding, and is recommended as the initial procedure for preoperative biliary drainage in patients with hilar cholangiocarcinoma.
The propensity score is the conditional probability of assignment to a particular treatment given a vector of observed covariates. Both large and small sample theory show that adjustment for the scalar propensity score is sufficient to remove bias due to all observed covariates. Applications include: (i) matched sampling on the univariate propensity score, which is a generalization of discriminant matching, (ii) multivariate adjustment by subclassification on the propensity score where the same subclasses are used to estimate treatment effects for all outcome variables and in all subpopulations, and (iii) visual representation of multivariate covariance adjustment by a two- dimensional plot.
Background
Although endoscopic biliary stents have been accepted as part of palliative therapy for cases of malignant hilar obstruction, the optimal endoscopic management regime remains controversial. In this study, we evaluated the safety and efficacy of placing a threaded stent above the sphincter of Oddi (threaded inside plastic stents, threaded PS) and compared the results with those of other stent types.
Methods
Patients with malignant hilar obstruction, including those requiring biliary drainage for stent occlusion, were selected. Patients received either one of the following endoscopic indwelling stents: threaded PS, conventional plastic stents (conventional PS), or metallic stents (MS). Duration of stent patency and the incident of complication were compared in these patients.
Results
Forty-two patients underwent placement of endoscopic indwelling stents (threaded PS = 12, conventional PS = 17, MS = 13). The median duration of threaded PS patency was significantly longer than that of conventional PS patency (142 vs. 32 days; P = 0.04, logrank test). The median duration of threaded PS and MS patency was not significantly different (142 vs. 150 days, P = 0.83). Stent migration did not occur in any group. Among patients who underwent threaded PS placement as a salvage therapy after MS obstruction due to tumor ingrowth, the median duration of MS patency was significantly shorter than that of threaded PS patency (123 vs. 240 days).
Conclusions
Threaded PS are safe and effective in cases of malignant hilar obstruction; moreover, it is a suitable therapeutic option not only for initial drainage but also for salvage therapy.
Despite the potentially severe impact of bile leakage on patients' perioperative and long-term outcome, a commonly used definition of this complication after hepatobiliary and pancreatic operations has not yet been established. The aim of the present article is to propose a uniform definition and severity grading of bile leakage after hepatobiliary and pancreatic operative therapy.
An international study group of hepatobiliary and pancreatic surgeons was convened. A consensus definition of bile leakage after hepatobiliary and pancreatic operative therapy was developed based on the postoperative course of bilirubin concentrations in patients' serum and drain fluid.
After evaluation of the postoperative course of bilirubin levels in the drain fluid of patients who underwent hepatobiliary and pancreatic operations, bile leakage was defined as bilirubin concentration in the drain fluid at least 3 times the serum bilirubin concentration on or after postoperative day 3 or as the need for radiologic or operative intervention resulting from biliary collections or bile peritonitis. Using this criterion severity of bile leakage was classified according to its impact on patients' clinical management. Grade A bile leakage causes no change in patients' clinical management. A Grade B bile leakage requires active therapeutic intervention but is manageable without relaparotomy, whereas in Grade C, bile leakage relaparotomy is required.
We propose a simple definition and severity grading of bile leakage after hepatobiliary and pancreatic operative therapy. The application of the present proposal will enable a standardized comparison of the results of different clinical trials and may facilitate an objective evaluation of diagnostic and therapeutic modalities in the field of hepatobiliary and pancreatic operative therapy.
Controversy exists over the preferred technique of preoperative biliary drainage (PBD) in patients with hilar cholangiocarcinoma (HCA). The goal of this retrospective study was to identify the preferred technique of PBD for HCA.
A total of 128 consecutive patients with HCA diagnosed between September 1999 and December 2009 who underwent PBD were included in this study. The study compared outcomes of endoscopic nasobiliary drainage (ENBD), endoscopic biliary stenting (EBS), and percutaneous transhepatic biliary drainage (PTBD) in patients with HCA.
There were no significant differences in preoperative laboratory data, rates of major hepatectomy, or decompression periods among the 3 groups. Complications were significantly more frequent in the EBS group compared with either the ENBD or PTBD group (p < 0.05). Drainage tube occlusion with cholangitis was significantly more common in the EBS group compared with either the ENBD or PTBD group (p < 0.0001). Patients in the PTBD group experienced serious complications including vascular injury (8%) and cancer dissemination (4%). Patients in the ENBD and EBS groups had mild post-endoscopic retrograde cholangiopancreatography pancreatitis (5%). Conversion procedures were significantly more common in the EBS group compared with the ENBD and PTBD groups (p < 0.05). There was no significant difference in postsurgical morbidity or mortality among the 3 groups.
Drainage tube occlusion with cholangitis was a frequent complication associated with EBS. PTBD was associated with serious complications such as vascular injury and cancer dissemination. ENBD was found to be the most suitable method for initial PBD management in patients with HCA.
To analyze the short-term surgical outcome of hepatobiliary resections for perihilar cholangiocarcinoma in the last 5 years.
Hepatobiliary resection for perihilar cholangiocarcinoma remains a technically demanding procedure, calling for a high level of expertise in biliary and hepatic surgery, and is still associated with significant morbidity or mortality.
Between 2000 and 2004, we surgically treated 102 consecutive patients with perihilar cholangiocarcinoma with a management strategy consisting of preoperative biliary drainage, portal vein embolization (for right-sided and extended left-sided resections), and major hepatobiliary resection. The data on all of the patients were analyzed retrospectively to identify the factors that might significantly affect the postoperative mortality and morbidity.
There were no cases of in-hospital mortality or postoperative liver failure. Major complications were encountered in 7 patients (6.9%), and the overall morbidity rate was 50%. Reoperation was required in 2 patients (2%). The overall median length of postoperative hospital stay was 26 days (range, 13-119 days). Univariate analysis in relation to the postoperative morbidity showed significant differences in the preoperative occurrence of segmental cholangitis or cholecystitis (P = 0.015), the severity of postoperative hyperbilirubinemia (P < 0.001), and the total amount of fresh frozen plasma administered (P = 0.002). Multivariate analysis revealed a single independent significant predictive factor for postoperative morbidity, namely, preoperative cholangitis or cholecystitis (odds ratio, 9.08; 95% confidence interval, 1.05-78.56, P = 0.045).
Our experience indicates that hepatobiliary resections for perihilar cholangiocarcinoma can be conducted safely, without a single case of postoperative liver failure or mortality. Occurrence of preoperative cholangitis or cholecystitis is a significant indicator for morbidity of major hepatobiliary resection.
Endoscopic management for perihilar cholangiocarcinoma (PHCC) is evolving toward more accurate diagnosis and safer drainage. In imaging, it is important to diagnose the entire lesion using multidetector‐row CT to determine resectability and optimal surgical planning, followed by local diagnosis using endoscopic retrograde cholangiopancreatography (ERCP). Video peroral cholangioscopy and probe‐based confocal laser endomicroscopy have been newly introduced as diagnostic imaging methods and are being applied clinically. In transpapillary forceps biopsy for PHCC diagnosis, the location in the bile duct (for mapping biopsy) and the number of biopsy samples should be determined depending on resectability, the morphological type, and future surgical planning. Preoperative drainage has shifted from percutaneous transhepatic biliary drainage to endoscopic nasobiliary drainage given the possibility of seeding metastasis. In addition, considering potential patient discomfort from a nasal tube, the usefulness of the placement of a plastic stent above the papilla (inside stent) as a bridging therapy for surgery has been reported. For drainage of unresectable PHCC, the improved prognosis due to advances in chemotherapy has necessitated a strategy that accounts for reintervention. Thus, in addition to uncovered self‐expandable metallic stents (SEMSs), exchangeable slim fully covered SEMSs and inside stents have started to be used. In addition to the conventional transpapillary approach, an EUS‐guided approach has been introduced, and a combination of both methods has also been proposed. To improve the quality of life and prognosis of PHCC patients, endoscopists need to understand and be able to use the various methods of endoscopic management for PHCC.
Objective:
The aim of this study was to define robust benchmark values for the surgical treatment of perihilar cholangiocarcinomas (PHC) to enable unbiased comparisons.
Background:
Despite ongoing efforts, postoperative mortality and morbidity remains high after complex liver surgery for PHC. Benchmark data of best achievable results in surgical PHC treatment are however still lacking.
Methods:
This study analyzed consecutive patients undergoing major liver surgery for PHC in 24 high-volume centers in 3 continents over the recent 5-year period (2014-2018) with a minimum follow-up of 1 year in each patient. Benchmark patients were those operated at high volume centers (≥50 cases during the study period) without the need for vascular reconstruction due to tumor invasion, or the presence of significant co-morbidities such as severe obesity (body mass index >35), diabetes, or cardiovascular diseases. Benchmark cutoff values were derived from the 75th or 25th percentile of the median values of all benchmark centers.
Results:
Seven hundred eight (39%) of a total of 1829 consecutive patients qualified as benchmark cases. Benchmark cut-offs included: R0 resection ≥57%, postoperative liver failure (International Study Group of Liver Surgery): ≤35%; in-hospital and 3-month mortality rates ≤8% and ≤13%, respectively; 3-month grade 3 complications and the CCI: ≤70% and ≤30.5, respectively; bile leak-rate: ≤47% and 5-year overall survival of ≥39.7%. Centers operating mostly on complex cases disclosed better outcome including lower post-operative liver failure rates (4% vs 13%; P = 0.002). Centers from Asia disclosed better outcomes.
Conclusion:
Surgery for PHC remains associated with high morbidity and mortality with now the availability of benchmark values covering 21 outcome parameters, which may serve as key references for comparison in any future analyses of individuals, group of patients or centers.
PurposeAlthough endoscopic naso-biliary drainage (ENBD) is a popular preoperative biliary drainage (PBD) method for patients with perihilar biliary malignancy (PHBM), patient discomfort caused by the nasal tube remains a problem. This study aimed to analyze the safety and efficacy of PBD with the placement of a plastic stent above the papilla [inside-stent (IS)] as a bridging therapy.Methods
The outcomes of 78 patients with potentially resectable PHBM, of whom 29 underwent IS placement and 49 underwent ENBD were evaluated.ResultsThe stent-associated complication rates were not different between the two groups (7% in the IS group and 10% in the ENBD group, P = 0.621). Catheter dislocation occurred less frequently (0% vs. 22%, P = 0.016), and the median time to recurrent biliary obstruction was longer (not reached vs. 32 days, P = 0.039) in the IS group than in the ENBD group. Among the patients who underwent resection, their postoperative severe complication rates were not substantially different (26% vs. 25%, P = 0.923).ConclusionIS placement is a possible alternative to ENBD as a bridge to a definitive operation for patients with resectable PHBM and a prospective trial to prove its feasibility and safety is therefore warranted.
Background
Few studies have focused on the risk factors for dysfunction of endoscopic biliary drainage (EBD) in preoperative patients with malignant hilar biliary obstruction (MHBO).
Methods
We searched the database between February 2011 and December 2018 and identified patients with MHBO who underwent radical operation. The rate of dysfunction of the initial EBD, risk factors for dysfunction of the initial EBD and survival after surgery were retrospectively evaluated.
Results
We analyzed a total of 131 patients [95 males (72.5%); mean age, 69.5(±7.3) years; Bismuth‐Corlette classification (BC) I/II/IIIa/IIIb/IV, 50/26/22/17/16; hilar cholangiocarcinoma/gall bladder cancer, 115/16]. Dysfunction of the initial EBD occurred in 28patients (21.4%). The cumulative incidences of dysfunction of the initial EBD in all patients were 18.4%, 38.2% and 47.0% at 30, 60 and 90days, respectively (Kaplan–Meier method). The rate of dysfunction of the initial EBD increased in patients with BC‐IV (P =0.03). Multivariate analysis showed that BC‐IV and pre‐EBD cholangitis were significantly associated with the occurrence of dysfunction of the initial EBD. Survival rates were not significantly different according to the initial biliary drainage methods and presence/absence of the initial EBD dysfunction.
Conclusions
Dysfunction of the initial EBD frequently occurs in patients with the BC‐IV and those with pre‐EBD cholangitis.
Background
Although there are many studies on technical outcomes of endoscopic naso‐biliary drainage (ENBD), no authors reported on preoperative course of patients undergoing ENBD. The aim of this study was to investigate the course of patients with ENBD during the waiting period.
Methods
Patients who underwent resection of perihilar cholangiocarcinoma (PHCC) between January 2013 and September 2017 were retrospectively reviewed.
Results
During the study period, 191 consecutive patients underwent surgical resection of PHCC after ENBD. Of the study patients, 154 (80.6%) patients were discharged, returned to their home, then re‐admitted for surgery. The remaining 37 patients were continuously hospitalized. The number of cholangitis events during the waiting period was 0 in 120 patients, 1 in 59 patients, 2≤ in 12 patients. Endoscopic re‐intervention was needed in 52 patients. The median length between the first admission and surgery was 37 days (range, 12 to 197 days) in the entire cohort; it was longer in patients with portal vein embolization than in those without (43 vs 27 days, P<0.001).
Conclusions
In patients undergoing resection of PHCC, ENBD is widely tolerable with relatively low incidence of cholangitis and thus recommended for preoperative biliary drainage.
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Background:
Morbidity and mortality after hepatectomy for perihilar cholangiocarcinoma are known to be high. However, reported postoperative outcomes vary, with notable differences between Western and Asian series. We aimed to determine morbidity and mortality rates after major hepatectomy in patients with perihilar cholangiocarcinoma and assess differences in outcome regarding geographic location and hospital volume.
Methods:
A systematic review was performed by searching the MEDLINE and EMBASE databases through November 20, 2017. Risk of bias was assessed and meta-analysis and metaregression were performed using a random effects model.
Results:
A total of 51 studies were included, representing 4,634 patients. Pooled 30-day and 90-day mortality were 5% (95% CI 3%-6%) and 9% (95% CI 6%-12%), respectively. Pooled overall morbidity and severe morbidity were 57% (95% CI 50%-64%) and 40% (95% CI 34%-47%), respectively. Western studies compared with Asian studies had a significantly higher 30-day mortality, 90-day mortality, and overall morbidity: 8% versus 2% (P < .001), 12% versus 3% (P < .001), and 63% versus 54% (P = .048), respectively. This effect on mortality remained significant after correcting for hospital volume. Univariate metaregression analysis showed no influence of hospital volume on mortality or morbidity, but when corrected for geographic location, higher hospital volume was associated with higher severe morbidity (P = .039).
Conclusion:
Morbidity and mortality rates after major hepatectomy for perihilar cholangiocarcinoma are high. The Western series showed a higher mortality compared with the Asian series, even when corrected for hospital volume. Standardized reporting of outcomes is necessary. Underlying causes for differences in outcomes between Asian and Western centers, such as differences in treatment strategies, should be further analyzed.
Main Recommendations
ESGE recommends against routine preoperative biliary drainage in patients with malignant extrahepatic biliary obstruction; preoperative biliary drainage should be reserved for patients with cholangitis, severe symptomatic jaundice (e. g., intense pruritus), or delayed surgery, or for before neoadjuvant chemotherapy in jaundiced patients. Strong recommendation, moderate quality evidence.
ESGE recommends the endoscopic placement of a 10-mm diameter self-expandable metal stent (SEMS) for preoperative biliary drainage of malignant extrahepatic biliary obstruction. Strong recommendation, moderate quality evidence.
ESGE recommends SEMS insertion for palliative drainage of of extrahepatic malignant biliary obstruction. Strong recommendation, high quality evidence.
ESGE recommends against the insertion of uncovered SEMS for the drainage of extrahepatic biliary obstruction of unconfirmed etiology. Strong recommendation, low quality evidence.
ESGE suggests against routine preoperative biliary drainage in patients with malignant hilar obstruction. Weak recommendation, low quality evidence.
ESGE recommends uncovered SEMSs for palliative drainage of malignant hilar obstruction. Strong recommendation, moderate quality evidence.
ESGE recommends temporary insertion of multiple plastic stents or of a fully covered SEMS for treatment of benign biliary strictures. Strong recommendation, moderate quality evidence.
ESGE recommends endoscopic placement of plastic stent(s) to treat bile duct leaks that are not due to transection of the common bile duct or common hepatic duct. Strong recommendation, moderate quality evidence.
Background and aim:
Endoscopic nasobiliary drainage (ENBD) is often recommended in preoperative biliary drainage (PBD) for hilar malignant biliary obstruction (MBO) but endoscopic biliary stent (EBS) is also used in the clinical practice. We conducted this large scale multicenter study to compare ENBD and EBS in this setting.
Methods:
A total of 374 cases undergoing PBD including 281 ENBD and 76 EBS for hilar MBO in 29 centers were retrospectively studied.
Results:
Extrahepatic cholangiocarcinoma (ECC) accounted for 69.8% and Bismuth-Corlette classification was III or more in 58.8% of the study population. Endoscopic PBD was technically successful in 94.6% and adverse event rate was 21.9%. The rate of post-ERCP pancreatitis was 16.0% and non-endoscopic sphincterotomy was the only risk factor (odds ratio [OR] 2.51). Preoperative re-intervention was performed in 61.5%: Planned re-interventions in 48.4% and unplanned re-interventions in 31.0%. PTBD was placed in 6.4% at the time of surgery. The risk factors for unplanned procedures were ECC (OR 2.64) and total bilirubin ≥10 mg/dL (OR 2.18). In surgically resected cases, prognostic factors were ECC (hazard ratio [HR] 0.57), predraiange MRCP (HR 1.62) and unplanned re-interventions (HR 1.81). EBS was not associated with increased adverse events, unplanned re-interventions or a poor prognosis.
Conclusions:
Our retrospective analysis did not demonstrate the advantage of ENBD over EBS as the initial PBD for resectable hilar MBO. Although the technical success rate of endoscopic PBD was high, its re-intervention rate was not negligible and unplanned re-intervention was associated with a poor prognosis in resected hilar MBO.
Background:
The strategy for preoperative management of biliary obstruction in hilar cholangiocarcinoma (HCCA) patients with regards to drainage by endoscopic (EBD) or percutaneous (PTBD) methods is not clearly defined. The aim of this study was to investigate the utility, complications and therapeutic efficacy of these methods in HCCA patients, with a secondary aim to assess the use of portal vein embolization (PVE) in patients undergoing drainage.
Methods:
Studies incorporating HCCA patients undergoing biliary drainage prior to curative resection were included (EMBASE and Medline databases). Analyses included baseline drainage data, procedure-related complications and efficacy, post-operative parameters, and meta-analyses where applicable.
Results:
Fifteen studies were included, with EBD performed in 536 patients (52%). Unilateral drainage of the future liver remnant was undertaken in 94% of patients. There was a trend towards higher procedure conversion (RR 7.36, p = 0.07) and cholangitis (RR 3.36, p = 0.15) rates in the EBD group. Where specified, 134 (30%) drained patients had PVE, in association with a major hepatectomy in 131 patients (98%). Post-operative hepatic failure occurred in 22 (11%) of EBD patients compared to 56 (13%) of PTBD patients, whilst median 1-year survival in these groups was 91% and 73%, respectively.
Discussion:
The accepted practice is for most jaundiced HCCA patients to have preoperative drainage of the future liver remnant. EBD may be associated with more immediate procedure-related complications, although it is certainly not inferior compared to PTBD in the long term.
Objective:
Although quality assessment is gaining increasing attention, there is still no consensus on how to define and grade postoperative complications. This shortcoming hampers comparison of outcome data among different centers and therapies and over time.
Patients and methods:
A classification of complications published by one of the authors in 1992 was critically re-evaluated and modified to increase its accuracy and its acceptability in the surgical community. Modifications mainly focused on the manner of reporting life-threatening and permanently disabling complications. The new grading system still mostly relies on the therapy used to treat the complication. The classification was tested in a cohort of 6336 patients who underwent elective general surgery at our institution. The reproducibility and personal judgment of the classification were evaluated through an international survey with 2 questionnaires sent to 10 surgical centers worldwide.
Results:
The new ranking system significantly correlated with complexity of surgery (P < 0.0001) as well as with the length of the hospital stay (P < 0.0001). A total of 144 surgeons from 10 different centers around the world and at different levels of training returned the survey. Ninety percent of the case presentations were correctly graded. The classification was considered to be simple (92% of the respondents), reproducible (91%), logical (92%), useful (90%), and comprehensive (89%). The answers of both questionnaires were not dependent on the origin of the reply and the level of training of the surgeons.
Conclusions:
The new complication classification appears reliable and may represent a compelling tool for quality assessment in surgery in all parts of the world.
Background:
Single preoperative biliary drainage for malignant perihilar biliary stricture occasionally fails to control jaundice and cholangitis. Multiple biliary drainage is required in such cases, but their clinical background is unclear. We determined the clinical characteristics associated with the requirement for multiple biliary drainage.
Methods:
The consecutive 122 patients with malignant perihilar biliary stricture were enrolled in a single-center retrospective study. Preoperative biliary drainage was initially performed on the future remnant hepatic lobe. Additional drainage was performed if jaundice failed to improve or cholangitis developed in undrained hepatic lobes. Detailed clinical characteristics and the number of preoperative biliary drainage procedures required before operation were analyzed.
Results:
Thirty-one patients (25.4%) initially underwent multiple biliary drainage. However, 69 (56.7%) required multiple biliary drainage by the time of the operation. In the univariate analysis, the initial serum bilirubin level, cholangitis, percutaneous portal vein embolization, history of inserted endoscopic biliary stenting, length of preoperative period, operative procedure, and Bismuth classification were significant factors. In the multivariate analysis using these factors, Bismuth classification was independently associated with the requirement for multiple biliary drainage. The number of patients who required multiple biliary drainage was higher in those with Bismuth-II (91.9%), Bismuth-IIIa (65.7%), and Bismuth-IV (92.9%) than in those with Bismuth-I (22.2%) and Bismuth-IIIb (18.2%).
Conclusions:
Patients with Bismuth-II, Bismuth-IIIa, and Bismuth-IV are at higher risk for multiple biliary drainage. A strategy based on the Bismuth classification for performing preoperative biliary drainage is important for patients with malignant perihilar biliary stricture.
Background
Plastic stent (PS) occlusion occurs as a result of bacterial adherence to the stent's inner wall. To retain the bacteriological barrier, placing a PS above the sphincter of Oddi (‘inside stent’) has been investigated. We designed a new PS (inside stent with thread [IT] stent) with attachable nylon thread for use as an inside stent and for easy retrieval. The present study evaluated the IT stent's technical feasibility and efficacy for malignant hilar biliary obstruction. Patients and MethodsA total of 26 consecutive patients with unresectable malignant hilar biliary obstruction underwent placement of IT stents from August 2007 to February 2011. IT stents were placed across the strictures without sphincterotomy to achieve bilateral drainage. ResultsThe overall technical success rate of the IT stent was 100% for one session. Multiple IT stents were inserted in 25 cases(two stents in 15 patients, three stents in 10 patients). No stent-related early complications occurred. The functional success rate was 92% (24/26). The rate of reintervention because of stent malfunction was 50% (13/26). In all 16 patients who underwent stent removal, IT stents were easily retrieved using the nylon thread. According to Kaplan–Meier analysis, the median stent patency period was 136 days. ConclusionIT stents for endoscopic placement above the sphincter of Oddi can be used safely and effectively for malignant hilar biliary obstruction.
Recent reports have addressed the utility of plastic stent (PS) placement inside bile ducts for treating biliary obstructions. Here, we evaluated the utility and safety of PS placement inside bile ducts for treating unresectable malignant hilar biliary obstruction.
We conducted a retrospective study of 27 patients with unresectable malignant hilar biliary obstruction who underwent intraductal modified PS placement. We modified the PS, by cutting off the distal end to facilitate insertion through the papilla of Vater, and attached a nylon thread to the distal end for removal. We evaluated complications, the time to recurrent biliary obstruction (TRBO), and removability.
Bilateral stenting was performed in nine of the 27 patients. Mild acute pancreatitis occurred in one patient (4%). Recurrent biliary obstruction (RBO) occurred in 16 patients (59%), with a median TRBO of 190 days (95% confidence interval: 174-205 days). Reintervention was necessary in 13 of the 16 patients (81%) with RBO, and we were able to remove the initial stents in all the patients who required reintervention.
A relatively long stent patency period (>6 months) and removability make placement of a modified PS inside bile ducts a viable treatment for unresectable malignant hilar biliary obstruction.
Discrimination between benign and malignant biliary strictures is difficult, with 5.2 to 24.5 per cent of biliary strictures proving to be benign after histological examination of the resected specimen. This study aimed to evaluate the clinicopathological features of benign biliary strictures in patients undergoing resection for presumed biliary malignancy. From January 1990 to August 2010, 5 of 153 (3.3%) patients who had undergone resection after a preoperative diagnosis of biliary malignancy had a final histological diagnosis of benign biliary stricture. The infiltration of immunoglobulin G4-positive plasma cells was evaluated by immunohistochemistry. None of the five patients had a history of trauma or earlier hepatobiliary surgery and all five underwent hemihepatectomy (combined with extrahepatic bile duct resection in three patients). Postoperative morbidity was recorded in two patients (transient cholangitis and biliary fistula), but there was no postoperative mortality. Histological re-examination identified immunoglobulin G4-related sclerosing cholangitis (n = 2) and nonspecific fibrosis/inflammation (n = 3). No preoperative clinical or radiographic features were identified that could reliably distinguish patients with benign biliary strictures from those with biliary malignancies. Although benign biliary strictures are rare, differentiating benign strictures from malignancy remains problematic. Thus, the treatment approach for biliary strictures should remain surgical resection for presumed biliary malignancy.
Objective:
To review our 34-year experience with 574 consecutive resections for perihilar cholangiocarcinoma and to evaluate the progress made in surgical treatment of this disease.
Background:
Few studies have reported improved surgical outcomes for perihilar cholangiocarcinoma; therefore, it is still unclear whether surgical treatment of this intractable disease has progressed.
Methods:
Between April 1977 and December 2010, a total of 754 consecutive patients with perihilar cholangiocarcinoma were treated, of whom 574 (76.1%) underwent resection. The medical records of these resected patients were retrospectively reviewed.
Results:
The incidence of major hepatectomies has increased, and limited resections, including central hepatectomies and bile duct resections, were rarely performed. Combined vascular resection was being used more often. Operative time has become shorter, and intraoperative blood loss has also decreased significantly. Because of refinements in surgical techniques and perioperative management, morbidity decreased significantly but was still high, with a rate of 43.1% in the last 5 years. Mortality rate has also decreased significantly (P < 0.001) from 11.1% (8/72) before 1990 to 1.4% (3/218) in the last 5 years. The ratio of advanced disease defined as pStage IVA and IVB has increased significantly from 49.4% before 2000 to 61.4% after 2001. The disease-specific survival for the 574 study patients (including all deaths) was 44.3% at year 3, 32.5% at year 5, and 19.9% at year 10. The survival was significantly better in the later period of 2001 to 2010 than in the earlier period of 1977 to 2000 (38.1% vs 23.1% at year 5, P < 0.001). For pM0, R0, and pN0 patients (n = 243), the survival in the later period was good with 67.1% at year 5, which was significantly better than that of the earlier period (P < 0.001). For pM0, R0, and pN1 patients (n = 142), however, the survival in the later period was similar to that of the earlier period (22.1% vs 14.6% at year 5, P = 0.647). Multivariate analysis revealed that lymph node metastasis was the strongest prognostic indicator.
Conclusions:
Surgical treatment of perihilar cholangiocarcinoma has been evolving steadily, with expanded surgical indication, decreased mortality, and increased survival. Survival for R0 and pN0 patients was satisfactory, whereas survival for pN1 patients was still poor, suggesting that establishment of effective adjuvant chemotherapy is needed.
Objective:
To assess the clinical benefits of preoperative endoscopic nasobiliary drainage (ENBD) in patients with perihilar cholangiocarcinoma.
Background:
The advantages of ENBD have been previously reported. However, no studies to date have examined a large number of patients, including those with Bismuth-Corlette (B-C) type III to IV tumors. In addition, sufficient data on the risk factors associated with ENBD complications are not available.
Methods:
This study involved 164 consecutive patients with suspected perihilar cholangiocarcinoma (128 patients with B-C type III-IV tumors) who had undergone unilateral ENBD between January 2007 and December 2010. The success and efficacy of this procedure and the risk factors for post-ENBD cholangitis and pancreatitis were retrospectively evaluated.
Results:
The ENBD procedure was successful in 153 (93.3%) of the 164 patients. Of these 164 patients, 65 had serum total bilirubin (TB) levels of 2.0 mg/dL or more before the drainage. The first unilateral ENBD was successfully performed in 60 of the 65 patients, and the TB level decreased to less than 2.0 mg/dL after ENBD in 50 of these 60 patients (83.3%). The significant predictive factors for ENBD efficacy included the pre-ENBD TB level (P = 0.032; 95% confidence interval [CI], 1.01-1.23) and post-ENBD cholangitis (P = 0.012; 95% CI, 1.61-43.2). Post-ENBD cholangitis occurred in 47 (28.8%) of the 163 patients, and a previous endoscopic sphincterotomy (EST) was found to be a significant risk factor for post-ENBD cholangitis (P = 0.008; 95% CI, 1.30-5.46). Post-ENBD pancreatitis occurred in 33 (20.1%) of the 164 patients (26 grade 1 patients, 4 grade 2 patients, and 3 grade 3 patients). The significant risk factors included undergoing pancreatography (P < 0.001; 95% CI, 2.44-31.1) and the absence of previous EBS or ENBD (P < 0.001; 95% CI, 3.03-29.2).
Conclusions:
Unilateral ENBD of the future remnant lobe(s) exhibited a high success rate, suggesting that it is an effective and suitable preoperative drainage method for perihilar cholangiocarcinoma even in patients with B-C type III to IV tumors. To reduce the postprocedural complications, ENBD should be performed without EST or pancreatography.
The aim of the study was to clarify the incidence, risk factors and treatment of percutaneous transhepatic biliary drainage (PTBD) catheter tract recurrence in patients with resected cholangiocarcinoma.
The medical records of 445 patients with perihilar and distal cholangiocarcinoma who underwent resection following PTBD were reviewed retrospectively.
PTBD catheter tract recurrence was detected in 23 patients (5.2 per cent). The mean(s.d.) interval between surgery and onset of the recurrence was 14.4(13.8) months. On multivariable analysis, duration of PTBD (60 days or more), multiple PTBD catheters and macroscopic papillary tumour type were identified as independent risk factors. In four patients with synchronous metastasis, the PTBD sinus tract was resected simultaneously, at the time of initial surgery. Of 19 patients with metachronous metastasis, 15 underwent surgical resection of the metastasis. Survival of the 23 patients with PTBD catheter tract recurrence was poorer than that of the 422 patients without recurrence (median 22.8 versus 27.3 months; P = 0.095). Even after surgical resection of PTBD catheter tract recurrence, survival was poor.
PTBD catheter tract recurrence is not unusual. The prognosis for these patients is generally poor, even after resection. To prevent this troublesome complication, endoscopic biliary drainage is first recommended when drainage is indicated.
Although percutaneous transhepatic biliary drainage has previously been recommended as a primary preoperative step, endoscopic nasobiliary drainage (ENBD) is prevalent as an alternative procedure. Few reports assess the efficacy and safety of ENBD in a substantial patient cohort.
Of 116 patients with hilar cholangiocarcinoma who underwent surgery, 62 (43 men and 19 women, median age 69 years) underwent preoperative ENBD. After classification of lesions according to Bismuth-Corlette (B-C) criteria, we evaluated efficacy and safety with respect to B-C type.
Patients were classified as B-C types I (n = 5), II (n = 21), IIIa (n = 23), IIIb (n = 5), and IV (n = 8). Preoperative single ENBD was effective in 46/62 patients (74%) including 5/5 (100%) B-C type I, 20/21 (94%) type II, 16/23 (70%) type IIIa, 4/5 (80%) type IIIb, and 1/8 (13%) type IV. Sixteen cases (26%) required additional drainages with ENBD or endoscopic biliary stenting (EBS) in 8/16 (50%), and with PTBD in 8/16 (50%). Mild acute pancreatitis (n = 1, 2%), segmental cholangitis (n = 2, 3%), and acute cholangitis with catheter obstruction (n = 7, 11%) occurred with ENBD.
Preoperative single ENBD in the future remnant lobe is effective treatment for B-C type I-III hilar cholangiocarcinoma. Preoperative ENBD was rarely complicated with segmental cholangitis.
Three types of preoperative biliary drainage (BD): percutaneous transhepatic (PTBD), endoscopic (EBD), and endoscopic nasobiliary (ENBD) can be indicated before resection of cholangiocarcinoma. However, three randomized controlled trials (RCTs) have revealed that preoperative PTBD does not improve perioperative results. Other RCTs have revealed that preoperative EBD for malignant obstructive jaundice has no demonstrable benefit and after EBD for hilar cholangiocarcinoma there are highly developed infectious complications. Most patients with distal cholangiocarcinoma undergo pancreatoduodenectomy (PD) without preoperative BD. However, no RCTs have been performed to clarify the safety of major hepatectomy without preoperative BD for cholestatic patients with hilar cholangiocarcinoma. Furthermore, preoperative intrahepatic segmental cholangitis is a prognostic factor in the outcome of major hepatectomy for biliary cancer. Preoperative BD has another purpose in the preoperative management of patients with hilar cholangiocarcinoma. Selective cholangiography via ENBD and/or PTBD catheters provides precise information about the complicated segmental anatomy of the intrahepatic bile ducts and extent of cancer along the separated segmental bile ducts, which contributes toward designing a type of resective procedure. RCTs in biliary cancer patients undergoing major hepatectomy have revealed that bile replacement during external biliary drainage and perioperative synbiotic treatment can prevent postoperative infectious complications. Although preoperative EBD increases the risk of cholangitis, major hepatectomy combined with preoperative biliary drainage, preferably PTBD and/or ENBD, followed by portal vein embolization has been established as a safer management strategy for perihilar cholangiocarcinoma.
To demonstrate our strategy for hilar bile duct cancer and to elucidate prognostic factors and the surgeon's role in long-term survival.
Extended hemihepatectomy is recognized as a curative treatment of hilar bile duct cancer but is not always safe because of the risk of postoperative liver failure. A safe and beneficial strategy is required.
Fifty-eight consecutive major hepatectomies for hilar bile duct cancer were reviewed retrospectively. Appropriate preoperative treatments, biliary drainage, and portal embolization were performed before major hepatectomies. The short- and long-term results of our strategy are presented and analyzed.
Biliary drainage and portal embolization were performed in 39 patients (67.2%) and 31 patients (53.4%), respectively. Major hepatectomies comprised 27 extended right and 22 extended left hemihepatectomies and 9 hepatoduodenopancreatectomies. Operative morbidity and mortality rates were 43% and 0%, respectively. There was no postoperative liver failure. The overall 5-year survival rate was 40%. Univariate analysis showed that residual tumor status, lymph node involvement, and perineural invasion were associated with patients' long-term survival. A surgical margin over 5 mm resulted in better long-term survival. The delay resulting from preoperative treatment was not detrimental to long-term survival. Multivariate analysis showed that lymph node involvement was the only prognostic factor.
Our strategy, which includes preoperative biliary drainage and portal embolization, led to a reduction in the risks associated with major hepatectomy for hilar bile duct cancer, and resulted in zero mortality. Surgeons should aim at complete clearance of the tumor with an adequate surgical margin to ensure optimal long-term survival.