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Endoscopic biliary drainage. (a), (b) X-ray image and endoscopic image of plastic stent. (c), (d) X-ray image and endoscopic image of metallic stent.
Source publication
Objective
. To elucidate the optimum preoperative biliary drainage method for patients with pancreatic cancer treated with neoadjuvant chemotherapy (NAC).
Material and Methods
. From January 2010 through December 2014, 20 patients with borderline resectable pancreatic cancer underwent preoperative biliary drainage and NAC with a plastic or metallic...
Citations
... In the case of patients with pancreatic cancer non-eligible for surgery the biliary stenting allows prolongation of survival time and is definitely more effective treatment compared to percutaneous biliary drainage [19]. In guidelines from 2018, the European Society of Gastrointestinal Endoscopy recommended use of SEMS in patients with malignant biliary strictures [20], which showed advantages over plastic stents in terms of survival time, quality of life, number of re-interventions and complications [21,22,23,24]. Similar recommendations were assumed by the American guidelines published in 2023 [25]. ...
Introduction:
Endoscopic stenting is a commonly applied method of treatment in patients with malignant biliary strictures. It involves the use of plastic stents (PS) or self-expandable metal stents (SEMS).
Objectives:
The aim of the study was to compare the effectiveness of SEMS versus PS in the endoscopic drainage of malignant stricture of the biliary tree and its sequels for future optimalisation of this treatment method.
Patients and methods:
Data of consecutive 618 patients with malignant biliary stricture in whom 1271 endoscopic retrograde cholangiopancreatography (ERCP) procedures with biliary stenting have been done within 2012-2017 with at least 3-year follow-up were retrospectively derived from hospital database.
Results:
The main indications for stenting were pancreatic cancer (37%) and cholangiocarcinoma (34%). The use of SEMS resulted in a greater decline of serum bilirubin compared to PS (37% vs. 32% of baseline concentration). Consequently, the hospital stay was shorter by more than two days (SEMS 9.5 vs PS 11.8 days; P<0.001). The patency time of SEMS was more than twice longer compared to plastic stents (118 vs 46 days; P<0.001) and the procedure-related complications were less frequent (19.3% vs 12.9%, respectively in SEMS and PS group; P=0.001). SEMS proved also to be cost-effective; the hospital profit was 1375 USD for the single hospitalization with SEMS vs PS insertion.
Conclusions:
In patients with malignant strictures of the biliary tree SEMS outperform plastic stents. SEMS should be used as a treatment of choice for biliary drainage in that group of patients.
... In addition, guidelines [3,5] already recommend CSEMS for biliary drainage during neoadjuvant chemotherapy. On the other hand, few reports compare the outcomes of PS and CSEMS in biliary drainage during neoadjuvant therapy in patients with BRPC [8][9][10][11][12][13][14], and there are only three reports [9][10][11] on a small number of around 20 patients limited to neoadjuvant chemotherapy. We aimed to clarify the utility of the CSEMS for biliary drainage during neoadjuvant chemotherapy in patients with BRPC. ...
... In addition, guidelines [3,5] already recommend CSEMS for biliary drainage during neoadjuvant chemotherapy. On the other hand, few reports compare the outcomes of PS and CSEMS in biliary drainage during neoadjuvant therapy in patients with BRPC [8][9][10][11][12][13][14], and there are only three reports [9][10][11] on a small number of around 20 patients limited to neoadjuvant chemotherapy. We aimed to clarify the utility of the CSEMS for biliary drainage during neoadjuvant chemotherapy in patients with BRPC. ...
... The present study revealed the usefulness of CSEMSs for biliary drainage during planned gemcitabine-based neoadjuvant chemotherapy in patients with BRPC. There have been several reports [8][9][10][11][12][13][14] comparing the outcomes of PS and CSEMS for biliary drainage during neoadjuvant therapy for PC (Table 5). Similar to this study, these studies showed the utility of CSEMS for PS in terms of fewer stent-related complications. ...
Objectives:
We aimed to compare the utility of covered self-expanding metal stents (CSEMSs) with that of plastic stents (PSs) for biliary drainage during neoadjuvant chemotherapy in patients with borderline resectable pancreatic cancer.
Methods:
Forty patients with borderline resectable pancreatic cancer underwent biliary stenting during neoadjuvant chemotherapy at Hiroshima University Hospital. PSs and CSEMSs were placed in 19 and 21 patients, respectively. Two gemcitabine-based regimens for chemotherapy were used. Treatment outcomes and postoperative complications were compared between both groups.
Results:
The incidence of recurrent biliary obstruction was significantly lower in the CSEMS group (0% vs. 47.4%, p < 0.001), and the median time to recurrent biliary obstruction in the PS group was 47 days. There was no difference in the incidence of other complications such as non-occlusive cholangitis, pancreatitis, and cholecystitis between the two groups. Delays in the chemotherapy schedule due to stent-related complications were significantly frequent in the PS group (52.6% vs. 4.8%, p = 0.001). There was no significant difference in the incidence of postoperative complications between the two groups.
Conclusions:
CSEMSs may be the best choice for safely performing neoadjuvant chemotherapy for several months in patients with borderline resectable pancreatic cancer with bile duct stricture.
... Compared with a PS, an MS has the advantages of longer patency and a lower reintervention rate. Nevertheless, although several studies have compared the efficacy and safety of an MS versus PS for NAT in patients with resectable or borderline resectable pancreatic cancer, there is no standard viewpoint on the best type of stent [7,8]. The preoperative and postoperative outcomes between an MS and PS remain controversial. ...
... After screening the titles and abstracts, an additional 97 articles were excluded for various reasons. Finally, 11 publications that met the inclusion criteria were selected for the current meta-analysis [7,8,[12][13][14][15][16][17][18][19][20]. A flowchart of the literature search process is shown in Fig. 1. ...
Background
This study was performed to compare a metal stent (MS) and plastic stent (PS) in terms of efficacy and complications during neoadjuvant therapy (NAT) and the perioperative period.
Methods
We performed an electronic search of the following databases until 1 June 2022: PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov. Studies comparing an MS versus PS for PBD in patients with pancreatic cancer undergoing NAT were included.
Results
The meta-analysis showed that use of an MS was associated with lower rates of reintervention (p < 0.00001), delay of NAT (p = 0.007), recurrent biliary obstruction (RBO) (p = 0.003), and cholangitis (p = 0.03). There were no significant differences between the two groups in terms of stent migration (p = 0.31), postoperative complications (p = 0.20), leakage (p = 0.90), and R0 resection (p = 0.50).
Conclusions
Use of an MS for PBD in patients with pancreatic cancer undergoing NAT followed by surgery was associated with lower rates of reintervention, delay of NAT, RBO, and cholangitis compared with use of a PS. However, the postoperative outcomes were comparable between the MS and PS. Further studies on this topic are recommended.
... Some studies have found that FCSEMS is more effective than PS for MBO among BRPC patients receiving NAT. Several RCTs have verified that the median patency of SEMS is 4-9 mo or more, which is notably longer than that of PS [108][109][110][111]. A recent RCT from Japan which included patients with BRPC who required PBD before GNP based NAT, illustrated that the rate of stent dysfunction was drastically lower in the FCSEMS arm than in the PS arm (18.2% vs 72.8%, P = 0.015), and showed that FCSEMS and PS had a similar safety profile and medical costs [112]. ...
Borderline resectable pancreatic cancer (BRPC) is a complex clinical entity with specific biological features. Criteria for resectability need to be assessed in combination with tumor anatomy and oncology. Neoadjuvant therapy (NAT) for BRPC patients is associated with additional survival benefits. Research is currently focused on exploring the optimal NAT regimen and more reliable ways of assessing response to NAT. More attention to management standards during NAT, including biliary drainage and nutritional support, is needed. Surgery remains the cornerstone of BRPC treatment and multidisciplinary teams can help to evaluate whether patients are suitable for surgery and provide individualized management during the perioperative period, including NAT responsiveness and the selection of surgical timing.
... Although there have been many studies comparing the use of plastic and metal stents in patients with pancreatic cancer (1,(13)(14)(15)(16)(17)(18)(19), there has been no meta-analysis to evaluate patients expected to undergo surgical removal after NAT. The purpose of this systematic review and meta-analysis was to compare the rate of endoscopic reintervention, stent-related complications, postoperative surgical complications, postoperative hospital stay, and total medical costs of metal versus plastic stents for PBD in patients with operable pancreatic cancer undergoing NAT therapy. ...
... Two of the eight studies (13,18) were randomized controlled trials and six (1,(14)(15)(16)(17)19) were retrospective cohort trials including 316 patients in total (Tables 1 and 2). Of the 316 patients, 152 patients (48%) were treated with metal stents and 164 patients (52%) were treated with plastic stents. ...
... Six studies (13)(14)(15)(16)(17)(18) containing 118 cases in metal stents group and 117 cases in plastic group, provided stent-related preoperative complications. Ι 2 = 72%, P = 0.003, a random effects model was used to pool the OR, and the rate of stentrelated preoperative complications in metal stents group (18/ 118, 15%) was statistically lower than that in plastic stents group (52/117, 44%) (OR = 0.17, 95% CI = 0.04-0.78, ...
With the increasing use of neoadjuvant therapy (NAT) in patients with pancreatic cancer to reduce tumor burden on prognosis, preoperative biliary drainage (PBD) is becoming increasingly necessary. The aim of this study was to summarize the latest evidence and compare the clinical efficacy of metal stents (MS) and plastic stents (PS) in patients undergoing neoadjuvant therapy for operable pancreatic cancer. Eligible studies were searched in PubMed, Embase and Cochrane Library from their inception to September 2021. In this study, RevMan 5.4 was used to perform the analyses. Two randomized controlled trials (RCTs) and six retrospective studies with 316 patients were included. All patients had pancreatic cancer and received NAT before surgical resection. Meta-analysis showed that the rate of endoscopic reintervention in MS (26/143, 18%) group was lower than that of PS (122/153, 80%) group (P < 0.05). The rate of stent-related complications in MS group was lower (18/118, 15%) than that of PS (52/117, 44%) group (P = 0.02). But there were no significant differences in operative time, operative blood loss, overall postoperative complications, postoperative hospitalization days and total medical costs between the two groups. For operable pancreatic cancer patients undergoing NAT surgery, MS was preferred over PS in terms of the incidence of endoscopic reintervention and stent-related complications. More clinical trials are needed in the future to confirm these data with higher levels of evidence.
... Previously, there has been conflicting evidence regarding the safety of ERCP stenting prior to pancreatoduodenectomy [4][5][6]. Despite an aggressive surgical approach, outcomes for pancreatic cancer remain poor, leading to an increasing utilization of biliary stenting to facilitate wider use of preoperative chemotherapy and a delay in surgical intervention [7][8][9]. Current guidelines do not recommend routinely use of ERCP stenting prior to surgery, however, stent placement may be considered with severe symptomatic jaundice, cholangitis or expected delay in surgery, such as neoadjuvant therapy [10]. ...
Background
Historically, pre-operative biliary stenting has been associated with higher infectious complication rates following pancreatoduodenectomy. However, alleviation of biliary obstruction is necessary for consideration of pre-operative chemotherapy, which may improve disease-free survival, or for mitigation of symptoms while awaiting surgery. Our aim is to compare contemporary post-operative complication risk among patients with pre-operative endoscopic retrograde cholangiopancreatography (ERCP) stenting compared to those without.
Methods
Patients who underwent a pancreatoduodenectomy for pancreatic cancer with biliary obstruction within the ACS-NSQIP registry from 2014 to 2017 were identified. The primary outcome was to compare the risk of 30-day complication (composite outcome) between patients with and without pre-operative ERCP stenting. Propensity score matching was used to ensure balanced baseline characteristics and log-binomial regression models were used to estimate risk ratios for overall perioperative complication between groups.
Results
From 6073 patients with obstructive jaundice undergoing pancreatoduodenectomy for pancreatic cancer, 92% (5564) were eligible for the study. After performing a propensity score matching on 20 baseline characteristics, 952 patients without stenting were matched to up to four patients who received pre-operative ERCP stenting (n = 3467) for a matched cohort of 4419. A total of 1901 (55%) patients with pre-operative ERCP stenting experienced a post-operative complication compared to 501 (53%) patients without stenting (risk ratio 1.04, 95% CI 0.97–1.11, p = 0.23).
Conclusion
Pre-operative ERCP stenting was not associated with an increased risk of post-operative complication in patients undergoing pancreatoduodenectomy with obstructive jaundice. Biliary stenting may be safely considered for symptom relief and to potentially facilitate pre-operative chemotherapy for pancreatic cancer.
... Recent data showed that self-expandable metal stent placement, at least 2 cm below the hilum, was not associated with technical difficulties and did not affect the outcomes of the surgery [33]. Table 1 shows the outcomes of preoperative biliary drainage between plastic stent and self-expandable metal stent placement in patients with distal malignant biliary obstruction [34][35][36][37][38][39][40]. Among the seven studies in Table 1, the rate of recurrent biliary obstruction in the plastic stent and self-expandable metal stent groups was 3.5-3.5% and 0-30.3%. ...
... Among the seven studies in Table 1, the rate of recurrent biliary obstruction in the plastic stent and self-expandable metal stent groups was 3.5-3.5% and 0-30.3%. Four studies showed that the rate of recurrent biliary obstruction was significantly lower in the self-expandable metal stent group than in the plastic stent group [35,[38][39][40]. Moreover, four studies reported that stent patency was significantly longer in the self-expandable metal stent group than plastic stent groups [34,36,39,40]. ...
Distal malignant biliary obstruction is caused by various malignant diseases that require biliary drainage. In patients with operable situations, preoperative biliary drainage is required to control jaundice and cholangitis until surgery. In view of tract seeding, endoscopic biliary drainage is the first choice. Since neoadjuvant therapies are being developed, the time to surgery is increasing, especially in pancreatic cancer cases. Therefore, it requires long stent patency. Recently, preoperative biliary drainage using self-expandable metal stents has been reported as a useful modality to secure long stent patency. In patients with unresectable distal malignant biliary obstruction, self-expandable metal stent is the first choice for maintaining long stent patency. Although there are many comparison studies between a covered and an uncovered self-expandable metal stent, their use is still controversial. Recently, endoscopic ultrasound-guided biliary drainage has been performed as an alternative treatment. The clinical success and stent patency are favorable. We should take into consideration that both endoscopic retrograde cholangiopancreatography-guided biliary drainage and endoscopic ultrasound-guided biliary drainage have advantages and disadvantages and chose the drainage method depending on the patient's situation or the expertise of the endoscopist. Here, we discuss the current status of endoscopic biliary drainage in patients with distal malignant biliary obstruction.
... Based on available literature, there exists uncertainty as to the cost-effectiveness of metal versus plastic stents for biliary drainage in the setting of neoadjuvant therapy. Indeed, some studies have suggested the superiority of initially inserting a metal biliary stent in this setting [12][13][14][15], while a retrospective study from Japan showed no difference in the effectiveness of both stents [16], and a US randomized controlled trial (RCT) demonstrated similar cost-effectiveness comparing both approaches [17]. We thus aimed to better characterize the cost-effectiveness of initial plastic versus metal biliary stent placement in patients with a resectable or borderline resectable pancreatic cancer causing biliary obstruction in whom pre-operative neoadjuvant therapy is planned. ...
... The secondary outcome of effectiveness was the mean time in days elapsed between initial stent insertion and a decision that the patient was indeed ready for surgery, if that was the case. Death was not considered in the model as there exist no data to suggest that either stenting strategy provides a survival benefit [12][13][14][15][16][17]. ...
... Twenty-six input variables were required to construct the model (▶ Table 1). Probabilities were extracted from six studies [12][13][14][15][16][17]. Drug chemotherapy costs were based on the Folforinox regimen (oxaliplatin, leucovorin, irinotecan, fluorouracil [22]). ...
Background and study aims Biliary stenting is indicated to relieve obstruction from borderline resectable pancreatic cancer while patients receive preoperative neoadjuvant therapy. We compared the cost-effectiveness of plastic versus metal biliary stenting in this setting.
Methods A decision tree analysis compares two competing types of biliary stents (initially metal vs. initially plastic) to treat malignant distal biliary obstruction while receiving neoadjuvant therapy with different scenarios including possible complications as bridge till the patient undergoes curative surgical attempt. Using published information, effectiveness was chosen as the probability of successfully reaching a state of being ready for surgery once chemotherapy was completed. Costs (2018 US$) were based on national data. A third-party payer perspective was adopted, and sensitivity analyses were performed over a time-horizon of one year.
Results Initially inserting a metal versus a plastic biliary stent was more efficacious with a higher probability of reaching the readiness for surgery endpoint (96 % vs. 85 %), on average 18 days earlier while also being less expensive (US$ 9,304 vs. US$ 11,538). Sensitivity analyses confirmed robustness of these results across varying probability assumptions of plausible ranges and remained a dominant strategy even when lowering the willingness-to-pay threshold to US$ 1,000.
Conclusions Initial metal stenting to relieve malignant biliary obstruction from borderline resectable pancreatic cancer in patients undergoing neoadjuvant therapy prior to surgery is a dominant intervention in economic terms, when compared to initially inserting a plastic biliary stent as it results in a greater proportion of patients being fit for surgery earlier and at a lower cost.
... In a comparison between PS and SEMS (although the preoperative waiting periods vary), many reports indicated that RBO incidence was significantly higher with PS use (20-97%) than with SEMS use (3-35%). 20,22,23,[56][57][58][59] This may be because the preoperative waiting periods were less than 1 month and 3-5 months in studies without NAC (Table 3) and with NAC (Table 4), respectively. Most of the adverse events caused by stent insertion were RBOs, with no difference in other incidents between PS and SEMS. ...
Obstructive jaundice is a major symptom of pancreatic head cancer, and although its amelioration is required before scheduling chemotherapy, the decision to perform biliary drainage for resectable pancreatic cancer has remained controversial. In recent years, the effectiveness of neoadjuvant therapy for pancreatic cancer has been reported. Preoperative biliary drainage has become increasingly necessary, making the choice of stent an important one; thus, the longer the waiting period extends through neoadjuvant chemotherapy, the more durable stents—such as self-expandable metallic stents, rather than plastic stents—would be desired as an option. Still, there is insufficient evidence regarding surgical outcomes and long-term prognosis, and further confirmatory studies are needed. Through this review, we aim to provide an update on the characteristics of biliary stents and preoperative biliary drainage for potentially resectable pancreatic cancer.
... 8 Many previous studies on biliary drainage for patients with unresectable pancreatic cancer indicated that a metal stent is superior to a plastic stent in terms of patency 9 ; however, a few recent studies also revealed longer patency and lower cost related to the stent occlusion of a metal stent than those of a plastic stent during NAC/NACRT. [10][11][12][13][14] It remains controversial which type of self-expandable metal stent (SEMS) is the most suitable for patients with resectable or borderline resectable pancreatic cancer during NAC/NACRT: an uncovered SEMS (USEMS), fully covered SEMS (FCSEMS) or partially covered SEMS (PCSEMS). During NAC/NACRT in patients with pancreatic cancer, the USEMS has been the standard SEMS for biliary decompression as well as during chemotherapy in patients with unresectable pancreatic cancer, but there have been few comparative studies on the patency and safety of SEMSs in curative surgery after neoadjuvant therapy. ...
Introduction
Neoadjuvant chemotherapy or neoadjuvant chemoradiotherapy (NAC/NACRT) for resectable/borderline resectable pancreatic cancers was recently performed to improve clinical outcomes and led to good results, although it remains controversial whether NAC/NACRT is beneficial for resectable pancreatic cancer. A few recent studies revealed longer patency and lower cost related to the stent occlusion of a metal stent than those of a plastic stent during NAC/NACRT. It also remains controversial which type of self-expandable metal stent (SEMS) is the most suitable for patients with resectable/borderline resectable pancreatic cancer during NAC/NACRT: an uncovered SEMS (USEMS), a fully covered SEMS (FCSEMS) or a partially covered SEMS (PCSEMS). So far, two randomised controlled trials indicated that a USEMS and an FCSEMS were similar in preoperative stent dysfunction and adverse event rate. Thus, we aimed to verify the non-inferiority of a PCSEMS to a USEMS in this multicentre randomised controlled trial.
Methods and analysis
We designed a multicentre randomised controlled trial, for which we will recruit 100 patients with resectable/borderline resectable pancreatic cancer and distal biliary obstruction scheduled for NAC/NACRT from 13 high-volume institutions. Patients will be randomly allocated to the PCSEMS group or USEMS group. The primary outcome measure is the preoperative biliary event rate. Data will be analysed after completion of the study. We will calculate the 95% CIs of the incidence of preoperative biliary events in each group and analyse whether the difference between them is within the non-inferiority margin (10%).
Ethics and dissemination
This study has been approved by the institutional review board of Hokkaido University Hospital. The results will be submitted for presentation at an international medical conference and published in a peer-reviewed journal.
Trial registration number
UMIN000041737; jRCT1012200002.
