Bile leakage after loop closure vs clip closure of the cystic duct during laparoscopic cholecystectomy: A retrospective analysis of a prospective cohort

Abstract

Background:
Laparoscopic cholecystectomy (LC) is one of the most frequently performed surgical procedures. Cystic stump leakage is an underestimated, potentially life threatening complication that occurs in 1%-6% of the patients. With a secure cystic duct occlusion technique during LC, bile leakage becomes a preventable complication.

Aim:
To investigate the effect of polydioxanone (PDS) loop closure of the cystic duct on bile leakage rate in LC patients.

Methods:
In this retrospective analysis of a prospective cohort, the effect of PDS loop closure of the cystic duct on bile leakage complication was compared to patients with conventional clip closure. Logistic regression analysis was used to develop a risk score to identify bile leakage risk. Leakage rate was assessed for categories of patients with increasing levels of bile leakage risk.

Results:
Of the 4359 patients who underwent LC, 136 (3%) underwent cystic duct closure by a PDS loop. Preoperatively, loop closure patients had significantly more complicated biliary disease compared to the clipped closure patients. In the loop closure cohort, zero (0%) bile leakage occurred compared to 59 of 4223 (1.4%) clip closure patients. For patients at increased bile leakage risk (risk score ≥ 1) rates were 1.6% and up to 13% (4/30) for clip closure patients with a risk score ≥ 4. This risk increase paralleled a stepwise increase of actual bile leakage complication for clip closure patients, which was not observed for loop closure patients.

Conclusion:
Cystic duct closure with a PDS loop during LC may reduce bile leakage in patients at increased risk for bile leakage.

Full text

World Journal of
Gastrointestinal Surgery
World J Gastrointest Surg 2020 January 27; 12(1): 1-33
ISSN 1948-9366 (online)
Published by Baishideng Publishing Group Inc

W J G S World Journal of
Gastrointestinal
Surgery
Contents Monthly Volume 12 Number 1 January 27, 2020
ORIGINAL ARTICLE
Basic Study
1Pathological abnormalities in splenic vasculature in non-cirrhotic portal hypertension: Its relevance in the
management of portal hypertension
Gupta S, Pottakkat B, Verma SK, Kalayarasan R, Chandrasekar A S, Pillai AA
Retrospective Cohort Study
9Bile leakage after loop closure vs clip closure of the cystic duct during laparoscopic cholecystectomy: A
retrospective analysis of a prospective cohort
Donkervoort SC, Dijksman LM, van Dijk AH, Clous EA, Boermeester MA, van Ramshorst B, Boerma D
Retrospective Study
17 Outcomes associated with the intention of loco-regional therapy prior to living donor liver transplantation
for hepatocellular carcinoma
Wu TH, Wang YC, Cheng CH, Lee CF, Wu TJ, Chou HS, Chan KM, Lee WC
CASE REPORT
28 Isolated colonic neurofibroma in the setting of Lynch syndrome: A case report and review of literature
Sun WY, Pandey A, Lee M, Wasilenko S, Karmali S
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Contents World Journal of Gastrointestinal Surgery
Volume 12 Number 1 January 27, 2020
ABOUT COVER Editorial Board Member of World Journal of Gastrointestinal Surgery, Jesus
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World Journal of Gastrointestinal Surgery
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ISSN 1948-9366 (online)
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W J G S World Journal of
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Submit a Manuscript: https://www.f6publishing.com World J Gastrointest Surg 2020 January 27; 12(1): 9-16
DOI: 10.4240/wjgs.v12.i1.9 ISSN 1948-9366 (online)
ORIGINAL ARTICLE
Retrospective Cohort Study
Bile leakage after loop closure vs clip closure of the cystic duct
during laparoscopic cholecystectomy: A retrospective analysis of a
prospective cohort
Sandra C Donkervoort, Lea M Dijksman, Aafke H van Dijk, Emile A Clous, Marja A Boermeester,
Bert van Ramshorst, Djamila Boerma
ORCID number: Sandra C
Donkervoort (0000-0003-1088-0761);
Lea M Dijksman
(0000-0001-9227-1390); Aafke H van
Dijk (0000-0001-9758-3609); Emile A
Clous (0000-0002-5544-6136); Marja
A Boermeester
(0000-0001-5941-5444); Bert van
Ramshorst (0000-0003-0865-0983);
Djamila Boerma
(0000-0001-9212-1317).
Author contributions: Donkervoort
SC designed the study and wrote
the manuscript; Dijksman LM
performed the statistical analysis
and deducted a risk score; van Dijk
AH collected the data and
reference articles; Clous EA
collected the data; Boermeester MA
helped write the manuscript with
emphasis on how to present the
findings; van Ramshorst B
critically reviewed the presented
data; Boerma D co-designed the
study and helped write the
manuscript.
Institutional review board
statement: The subject of this study
concerns usual care without an
intervention. The study was
reviewed and approved by the
MEC OLVG Institutional Review
Board.
Informed consent statement: The
subject of this study concerns usual
care without an intervention. An
informed consent was not
applicable to our study.
Sandra C Donkervoort, Emile A Clous, Department of Surgery, Onze Lieve Vrouwe Gasthuis,
Amsterdam 1090 HM, Netherlands
Lea M Dijksman, Bert van Ramshorst, Djamila Boerma, Department of Research and
Epidemiology, St. Antonius Hospital, Nieuwegein 3435 CM, Netherlands
Aafke H van Dijk, Marja A Boermeester, Department of Surgery, Academic Medical Centre,
Amsterdam 1105 AZ, Netherlands
Corresponding author: Sandra C Donkervoort, MD, PhD, Surgeon, Department of Surgery,
Onze Lieve Vrouwe Gasthuis, PO-box 95500, Amsterdam 1090 HM, Netherlands. s.c.donker-
voort@olvg.nl
Abstract
BACKGROUND
Laparoscopic cholecystectomy (LC) is one of the most frequently performed
surgical procedures. Cystic stump leakage is an underestimated, potentially life
threatening complication that occurs in 1%-6% of the patients. With a secure
cystic duct occlusion technique during LC, bile leakage becomes a preventable
complication.
AIM
To investigate the effect of polydioxanone (PDS) loop closure of the cystic duct on
bile leakage rate in LC patients.
METHODS
In this retrospective analysis of a prospective cohort, the effect of PDS loop
closure of the cystic duct on bile leakage complication was compared to patients
with conventional clip closure. Logistic regression analysis was used to develop a
risk score to identify bile leakage risk. Leakage rate was assessed for categories of
patients with increasing levels of bile leakage risk.
RESULTS
Of the 4359 patients who underwent LC, 136 (3%) underwent cystic duct closure
by a PDS loop. Preoperatively, loop closure patients had significantly more
complicated biliary disease compared to the clipped closure patients. In the loop
WJGS https://www.wjgnet.com
January 27, 2020 Volume 12 Issue 1
9

Conflict-of-interest statement: The
authors declare no conflicts of
interest.
STROBE statement: The authors
have read the STROBE Statement-
checklist of items, and the
manuscript was prepared and
revised according to the STROBE
Statement-checklist of items.
Open-Access: This article is an
open-access article which was
selected by an in-house editor and
fully peer-reviewed by external
reviewers. It is distributed in
accordance with the Creative
Commons Attribution Non
Commercial (CC BY-NC 4.0)
license, which permits others to
distribute, remix, adapt, build
upon this work non-commercially,
and license their derivative works
on different terms, provided the
original work is properly cited and
the use is non-commercial. See:
http://creativecommons.org/licen
ses/by-nc/4.0/
Manuscript source: Unsolicited
manuscript
Received: June 16, 2019
Peer-review started: June 19, 2019
First decision: August 2, 2019
Revised: October 19, 2019
Accepted: November 20, 2019
Article in press: November 20, 2019
Published online: January 27, 2020
P-Reviewer: Vagholkar K
S-Editor: Yan JP
L-Editor: Filipodia
E-Editor: Ma YJ
closure cohort, zero (0%) bile leakage occurred compared to 59 of 4223 (1.4%) clip
closure patients. For patients at increased bile leakage risk (risk score ≥ 1) rates
were 1.6% and up to 13% (4/30) for clip closure patients with a risk score ≥ 4.
This risk increase paralleled a stepwise increase of actual bile leakage
complication for clip closure patients, which was not observed for loop closure
patients.
CONCLUSION
Cystic duct closure with a PDS loop during LC may reduce bile leakage in
patients at increased risk for bile leakage.
Key words: Laparoscopic cholecystectomy; Cystic duct occlusion; Bile leak; Endo-loop
©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
Core tip: Laparoscopic cholecystectomy is one of the most frequently performed surgical
procedures. Cystic duct leakage is an underestimated, potentially life threatening
complication. With a secure cystic duct occlusion technique, bile leakage becomes a
preventable complication. Assessing leakage rates for both clipped and looped patients,
we found that in clip closure patients, leakage rates increased from 0.9% up to 13%
depending upon their bile leakage risk, whereas loop closure patients leakage rates
remained 0%, even for patients at highest risk. Cystic duct closure with a polydioxanone
loop may well be a secure occlusion technique.
Citation: Donkervoort SC, Dijksman LM, van Dijk AH, Clous EA, Boermeester MA, van
Ramshorst B, Boerma D. Bile leakage after loop closure vs clip closure of the cystic duct
during laparoscopic cholecystectomy: A retrospective analysis of a prospective cohort. World
J Gastrointest Surg 2020; 12(1): 9-16
URL: https://www.wjgnet.com/1948-9366/full/v12/i1/9.htm
DOI: https://dx.doi.org/10.4240/wjgs.v12.i1.9
INTRODUCTION
Laparoscopic cholecystectomy (LC) is one of the most frequently performed surgical
procedures. Bile duct injury is a postoperative complication associated with
significant morbidity[1,2]. Reports on the rate of bile duct injury as a complication of LC
have consistently varied from 0.5% to 1%[3,4]. Recently, it has been reported that cystic
stump leakage rates (type A bile duct injury) are underestimated, especially in a
subpopulation of patients with complex biliary disease[5]. Patients with previous
biliary events [history of cholecystitis, cholangitis, pre-operative endoscopic
retrograde cholangiopancreatography (ERCP) for suspected choledocholithiasis] or
acute cholecystitis are at increased risk (4%-7%) for cystic stump leakage[6,7]. These
patients often require percutaneous drainage of the biloma, endoscopic
sphincterotomy, stent placement, or even re-laparoscopy or re-laparotomy[5,8].
Bile leakage from the cystic stump can be regarded a preventable complication, if
during LC the cystic duct is correctly and securely occluded. To date, the application
of non-absorbable metal clips for cystic duct closure is the standard of care in most
hospitals and countries[8]. As an alternative for metal clips, we introduced the use of
absorbable polydioxanone ligature (loops) for which few reports in literature can be
found[1,9-15].
This technique is now the standard for appendix stump closure in appendectomy
and has been widely reported. A decrease in bile leakage rate after LC may well be
achieved using loop cystic duct closure, especially in the subpopulation of patients
with complicated biliary disease. If so, this technique will lead to important
improvements in patient safety for patients undergoing LC. However, there is little
high quality evidence to support the hypothesis that looping the cystic duct during
LC is safer than clipping.
In the present study, we analysed the effect of closure of the cystic duct using
polydioxanone loops on overall bile leakage rate from the cystic duct in patients
undergoing LC. Leakage rates were additionally assessed for patients identified as
being at risk for postoperative bile leakage complication.
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Donkervoort SC et al. Bile leakage after loop closure
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MATERIALS AND METHODS
Data source
The study cohort was part of a database created for all consecutive patients who
underwent LC for symptomatic cholecystolithiasis over a 10-year period (2002-2012)
in two large teaching hospitals. Details on data retrieval of both cohorts until 2009
have been previously described in more detail[16,17]. Data entry of patients with loop
cystic duct closure into this database ran thereafter until June 2012.
Study population
The looped cystic duct closure was introduced after our previous studies on timing of
LC after ERCP showed cystic stump leakage rates to be 3%-5% for patient who had
undergone ERCP prior to LC[17,18].
The technique used to close the cystic duct has been recorded in all patients from
the original operative reports. The standard of care in that period was the use of three
parallel clips, two proximal and one distal, with transection of the cystic duct leaving
two parallel clips in situ. In the loop closure group patients underwent an LC in
which the cystic stump was closed after transection by a polydioxanone ligature
(loop). In September 2010 loop-closure of the cystic stump was introduced in patients
who underwent LC for complicated gallstone disease or when confronted with a wide
or inflamed cystic duct during LC. After more experience was gained in the use of
loops, the use of loop closure in patients with less evidently inflamed cystic ducts
became more naturally, and use expanded. When polydioxanone ligature (loop) was
used, the cystic duct was transected between two non-resorbable clips. The loop was
then placed over de cystic duct stump behind the clip that initially secured the cystic
stump.
Patient characteristics and outcome variables
Patient age, gender, co-morbidity as well as disease characteristics were noted. The
primary end point of this study was the occurrence of bile leakage from the cystic
duct stump. Post-operative bile leakage complications were identified by chart
review. Identification of bile leakage complications was done by meticulous screening
of postoperative charts, blood results, radiology reports, and readmission notes. To
search for all bile leakage complications (predominantly type A bile leaks), the
occurrence of post-operative re-interventions by ERCP, percutaneous drainage
procedures or re-laparoscopy, and re-laparotomy were checked. In addition,
complication data were compared with hospital complication registration systems.
The effect of a loop on bile leakage complication was analysed by determining
overall bile leakage rates for both clipped and looped patients. We also assessed the
bile leakage rate in the period before the introduction of loop closure in clinical
practice (clip closure only period, 2002-2010) in comparison with the period after the
introduction of loop closure (mixed closure period, 2010-2012).
Statistical analysis
Statistical analysis was performed using SPSS version 19.0. Statistical significance is
expressed as P < 0.05. Categorical data were shown as number (%) and compared
using the Pearson χ2 or Fisher’s Exact test (where appropriate). Continuous data were
shown as median with interquartile range (25%-75%) and compared using the Mann-
Whitney U test. In this study we did not use comparative statistics analysis, when
describing groups with one or more zero–cell counts as calculation of P value is less
reliable in such cases and regular statistical tests are not designed for data with zero
events.
From our database, independent risk variables predicting for a bile leakage
complication were extracted. Risk variables included patient characteristics such as
gender, age, American Society of Anaesthesiology (ASA) classification and body mass
index. Furthermore, disease events such as previous choledocholithiasis, acute
cholecystitis, pancreatitis and previous cholecystitis operated on in delayed setting
were taken into account. With these variables a risk score was created as a tool to
identify and define patients at increased risk for a bile leakage complication.
Therefore, we used univariate and multivariate analyses with binomial logistic
regression. All factors with a univariate P value < 0.1 were used in multivariate
analysis. A risk score was created using the beta-coefficient from factors contributing
to the multivariate analysis, for which variables with P < 0.1 were taken into account
because of the small sample size of the loop closure group. Scores were calculated by
dividing the beta of each variable by the lowest beta and then rounded. The sum of
these values was expressed in a final risk score. For this retrospective study, the
Medical Ethical Committee at the OLVG reviewed the study protocol and a waiver
was granted.
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January 27, 2020 Volume 12 Issue 1
Donkervoort SC et al. Bile leakage after loop closure
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RESULTS
A total of 4359 patients underwent LC in one of the two hospitals. The median age
was 50 years (interquartile range 39-62). About half of the patients were female (54%).
A total of 136 of 4359 (3%) patients underwent cystic duct closure by a loop (loop
closure group) instead of traditional closure by clips only (clip closure group).
Table 1 shows the demographic data of patients in the clip closure and loop closure
groups. Loop closure was significantly more often used in older patients (P = 0.038),
co-morbid patients (P = 0.021), and patients with complicated biliary disease: Pre-
operative ERCP (P = 0.001), previous cholecystitis (P < 0.001) and acute cholecystitis
(P < 0.001).
The overall bile leakage rate was 1.4% (59 of 4359 patients). Stratification for bile
leakage risk of patients was done by developing a risk score based on logistic
regression analysis (Table 2). Patients at risk for bile leakage in our population were
patients with a higher (3 or 4) ASA classification (odds ratio [OR]: 1.7, 95% confidence
interval [CI]: 0.9-3.3, P = 0.09), pre-operative ERCP (OR: 1.9, 95%CI: 1.5-2.5, P = 0.037),
acute cholecystitis (OR: 2.7, 95%CI: 1.4-5.0, P = 0.002) and/or previous cholecystitis
(OR: 5.1, 95%CI: 2.3-11.4, P < 0.001). The risk score, which was deducted from the beta
values, showed patients with a previous cholecystitis to be at highest risk for a post-
cholecystectomy bile leakage complication. Male gender, age, and pre-operative
pancreatitis were not independent predictors for bile leakage complication.
Figure 1 displays the bile leakage rates for both groups as a function of predicted
bile leakage risks. The clip closure patients without a predicted bile leakage risk were
shown to have a 0.9% bile leakage rate (27 of 3154) vs 0% (0 of 60) for the low risk loop
closure patients. For patients in the clip closure group with a bile risk score ≥ 1,
leakage rate was 3.1% (33/1069), whereas 0% (0/76) in the intermediate-high risk loop
closure patients had bile leakage. Leakage rates increased up to 13% (4/30) for
patients with a risk score ≥ 4 or higher in the clip closure group vs 0% (0/3) for the
loop closure group. No comparative statistics analysis was done because the loop
closure group had zero events.
When comparing the time period with clip closure only to the time period in which
clip closure as well as loop closure were used, overall bile leakage rates were 1.6%
(41/2633) and 1.1% (19/1726; P = 0.2) respectively. No significant differences between
observed bile leakage were found between the two time periods when stratifying for
predicted risk of bile leakage; 0.9% (9/1307) vs 0.7% (18/1907; P = 0.44), respectively
for the low risk patients, and 3.2% (23/726) vs 2.4% (10/419; P = 0.45), respectively for
the high-risk patients (Figure 2).
DISCUSSION
In this prospective consecutive series, no bile leakage complications occurred in
patients with loop closure of the cystic duct during LC, whereas after clip closure bile
leakage rates varied from 2% to 13% depending on patients’ bile leakage risk profile.
This result stands out in particular, because loop closure was used more frequently in
patients with an increased bile leakage risk.
Recently we showed that bile leakage risk is underestimated in the literature[6].
Postoperative bile leakage can occur from cystic duct stump leakage due to unsecured
closure of the cystic duct, leakage from an accessory duct on the liver bed (Luska) and
injury to the common bile duct. The focus in our study was cystic duct stump leakage
(type A bile leaks) due to unsecured closure. If a secure technique can be identified
improvements can be pursued, avoiding a potentially life threatening complication.
Leakage rates are consistently reported to be 1%-2%[3,4,19,20]. Patients with
uncomplicated symptomatic biliary disease have a 1% bile leakage rate, but a
subgroup of patients with complicated biliary disease due to pre-operative ERCP for
suspected choledocholithiasis, patients with an acute cholecystitis, and patients with a
delayed cholecystectomy have a cystic duct leakage rate up to 6%[6]. The risk score
provided the possibility to stratify for pre-operative risk for bile leakage and thus
more complex procedures. Present data showed that the loop closure group had a
very low leakage rate, even in the more difficult cases.
Focus on bile leakage complications after LC is important as there is a lot to gain. It
is an unwanted complication with potential high morbidity inducing high healthcare
costs as patients often require endoscopic intervention depending upon the nature of
the leakage, with or without a percutaneous drainage procedure, re-laparoscopy, or
even re-laparotomy[21-24]. Although the reported success rate of an initial treatment of
bile leakage is high (96%), it is still a potentially life threatening situation, possibly
leading to sepsis and multiple organ failure due to biliary peritonitis[2].
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January 27, 2020 Volume 12 Issue 1
Donkervoort SC et al. Bile leakage after loop closure
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Table 1 Demographics and baseline data
Total, n = 4359 Clipped cystic duct, n = 4223 PDS loop cystic duct, n = 136 P value
Patient characteristics
Age, median (IQR) 50 (39-62) 58 (43-71) 49 (38-61)
> 65 yr, n (%) 869 832 (20) 37 (27) 0.038
Male, n (%) 2012 1945 (46) 67 (49) NS
ASA 3-4, n (%) 239 225 (7) 14 (13) 0.021
History prior to LC
Pre-operative ERCP 612 580 (14) 32 (24) 0.001
Pancreatitis 258 254 (6) 13 (10) 0.065
Previous cholecystitis 132 116 (3) 16 (12) < 0.001
Indication for surgery < 0.001
Sympt. biliary disease, n (%) 3737 3652 (87) 85 (62)
Acute cholecystitis, n (%) 622 571 (13) 51 (38)
All variables are in median. A total of 949 (22%) missing cases for American Society of Anaesthesiology (ASA) classification. NS: Not significant; IQR:
Interquartile range (25%-75%) or in number (%); ASA 3-4: American Society of Anaesthesiology of 3 and 4; ERCP: Endoscopic retrograde
cholangiopancreatography; LC: Laparoscopic cholecystectomy; PDS: Polydioxanone.
Bile leakage after LC due to the failure of a closed cystic stump (1%) is preventable
if a secure closing technique is used during cholecystectomy[3,25]. Different techniques
for cystic duct closure exist, of which the placement of non-resorbable metal clips has
been the standard of care to date. Clipped closure is reportedly complicated by post-
operative bile leakage due to laceration of the duct[26], through the conduction of
electricity[27], necrosis of the clamped tissue[28], or migration of the clips[6,11,29,30],
especially when placed on inflamed tissue.
Other techniques of cystic duct closure, such as absorbable clips, ligatures, and
vessel sealants, have been proposed. Gurusamy et al[31] reported a systematic review of
three trials including a total of 255 patients. Duct occlusion with absorbable clips, non-
absorbable clips, and absorbable ligatures were compared. All three trials consisted of
no more than 75 patients per group and were at high risk for bias. No difference in
bile leakage complication between the groups was found.
Since the widespread use of harmonic scalpel (Ethicon Endo-Surgery, Cincinnati,
OH, United States) and vessel sealants (LigaSure™) in laparoscopic surgery, these
techniques have also been explored for closure of the cystic duct. Although studies
have shown that these techniques are deemed safe and efficient, they have at least
comparable bile leakage rates (1.75%) as clips[32,33].
Reports on other techniques of cystic stump closure (i.e. metal clips, locking clips,
ligatures) are limited. There is not enough high quality evidence to either encourage
or discourage a specific technique of closure during LC. As the overall bile leakage
rate (1%) is low in LC, studies with a large number of patients are necessary to deliver
evidence for superior cystic duct closure. When searching for a superior cystic duct
closure technique, a study design with a subpopulation of high-risk patients will give
the best insight. None of the aforementioned studies used a subpopulation with an
increased risk for bile leakage complication for analysis. We are the first to analyse
bile leakage complication in a subpopulation of patients with multiple risk factors for
leakage. Previously we found that LC is technically more difficult in “complicated”
biliary disease compared to patients with “uncomplicated” biliary disease[7,14]. Here,
we show that bile leakage outcome is different for these subgroups and advocate to
recognise that patients with gallstone disease consist of two different disease entities,
”uncomplicated” and “complicated” disease.
Present data should be regarded with caution. A few limitations of the present
study have to be highlighted: First, the low number of looped patients; the looped
cohort consisted of only 3% of the total population. No events/bile leakage occurred
in the looped cystic duct group, which made statistical analysis difficult. The lack of
events may have been caused by chance rather than an effect of the loop closure. No
formal sample size calculation was done in this retrospective setup. Larger patient
populations are needed to be able for a more accurate estimation of the effect.
However, with all limitations in mind, loop closure of the cystic duct performed far
better than the clip closure group, and foremost, better than expected based on
predicted risk of postoperative bile leakage.
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Donkervoort SC et al. Bile leakage after loop closure
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Table 2 Stratification of 4359 patients after laparoscopic cholecystectomy, according to risk score prediction of bile leakage based on a
logistic regression model
Multivariable Beta Risk score
OR (95%CI) P value
Male gender - - - -
Age > 65 yr - - - -
ASA 3-4 2.0 (0.9-4.1) 0.074 0.68 1
Pre-op ERCP 1.7 (0.9-3.3) 0.094 0.54 1
Pre-op pancreatitis - - - -
Acute cholecystitis 2.7 (1.4-5.0) 0.002 0.98 2
Delayed surgery for previous cholecystitis 5.1 (2.3-11.4) < 0.001 1.63 3
Maximum score 5
OR and CI with multivariable logistic regression analysis. CI: Confidence interval; OR: Odds ratio; ASA 3-4: American Society of Anaesthesiology of 3 and
4; ERCP: Endoscopic retrograde cholangiopancreatography; ASA: American Society of Anaesthesiology; pre-op ERCP: Pre-operative endoscopic
retrograde cholangiopancreatography; Delayed surgery: Patients treated after a previous cholecystitis in a delayed setting; Maximum score: Delayed and
acute cholecystitis exclude each other.
Figure 1
Figure 1 Identified risk for a bile leakage complication and bile leakage rate for clip closure and loop closure patients. X-axis: Summarised risk score for bile
leakage complication; Y-axis: Percentage of patients with and without bile leakage in loop closure patients and cystic duct closure patients.
Figure 2
Figure 2 Bile leakage complication rate in patients after laparoscopic cholecystectomy for the period with only clip closure of the cystic duct (clip closure
only period) and the period after loop cystic duct closure had been introduced (mixed closure period). No risk score: No bile leakage risk according to risk
score prediction of Table 2; Risk score ≥ 1: Bile leakage risk score ≥ 1 according to risk score prediction of Table 2.
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Donkervoort SC et al. Bile leakage after loop closure
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ARTICLE HIGHLIGHTS
Research background
Laparoscopic cholecystectomy (LC) is one of the most frequently performed surgical procedures.
Cystic stump leakage is an underestimated, potentially life threatening complication and still
occurs in 1%-6% of the patients. If a secure cystic duct occlusion technique can be found bile
leakage becomes a preventable complication and morbidity from LC significantly reduced. With
our study we believe to contribute to a reduction in bile leakage rates.
Research motivation
The main topic is cystic stump leakage complication after LC. The key problem is that this
complication is underestimated and still occurs in 1%-6% of patients. We can solve this
unnecessary complication by finding a secure cystic duct closure technique. As yet data on cystic
duct closure technique is scars, using a polydioxanone (PDS) loop has not been described in a
significant cohort yet. We find the use of a loop very promising and an interesting topic for
future research.
Research objectives
To investigate the effect of PDS loop closure of the cystic duct on bile leakage rate in LC patients
and compare bile leakage complication with the conventional clipped closure technique in
patients with and without increased bile leakage risk. We show that PDS loop closure is a safe
closure technique, as 0% bile leakage complications occurred even in high risk patients; whereas,
in clipped closure patients the bile leakage rate increased from 0.9 up to 13%, dependent upon
the bile leakage risk. PDS loop closure technique deserves more attention.
Research methods
In this retrospective analysis of a prospective cohort, the effect of PDS loop closure of the cystic
duct on bile leakage complication was compared to patients with conventional clip closure.
Logistic regression analysis was used to develop a risk score to identify bile leakage risk.
Leakage rate was assessed for categories of patients with increasing levels of bile leakage risk.
This is a novel approach to the problem.
Research results
We show that PDS loop closure is a safe closure technique, as 0% bile leakage complications
occurred even in high risk patients; whereas, in clipped closure patients bile the leakage rate
increased from 0.9% up to 13%, dependent upon the bile leakage risk. PDS loop closure
technique deserves more attention. This study contributes to a more secure cystic duct closure
technique during LC and can motivate to further investigate this closure technique to increase
the level of evidence.
Research conclusions
Cystic duct closure with a PDS loop during LC may reduce bile leakage in patients at increased
risk for bile leakage.
Research perspectives
PDS loop is a potential secure cystic duct closure technique with no bile leakage complication
risk even in high-risk patients. A change in cystic duct closure technique has already been
implemented in our institution. The conventional clipped closure technique is not used in
patients at risk for bile leakage complication. Randomised controlled trial or large prospective
multicentre cohort.
ACKNOWLEDGEMENTS
We would like to thank Joep. E.E.M Maeijer from the AVD of Teaching Hospital at
OLVG for his creative support in creating figures.
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