Is the rate of bile leak higher in clipless laparoscopic cholecystectomy compared to conventional cholecystectomy?

A best evidence topic has been constructed using a described protocol. The three-part question addressed was: In patients undergoing cholecystectomy is the clipless laparoscopic cholecystectomy is associated with higher risk of bile leak compared to conventional cholecystectomy? The search has been devised and 6 studies were deemed to be suitable to answer the question. The outcome assessed was the rate of bile leak in clipless cholecystectomy compared to conventional laparoscopic cholecystectomy. Authors found that the rates of bile leak in clipless laparoscopic cholecystectomy is comparable to conventional technique. Clipless cholecystectomy is feasible and safe.


Introduction
This BET was constructed using a framework outlined by the International Journal of Surgery [1]. A BET provides evidence-based answers to common clinical questions, using a systematic approach of reviewing the literature.

Clinical scenario
Laparoscopic cholecystectomy is one of the most common performed procedures worldwide. As a surgical trainee who does different rotations in different hospitals, probably you will operate with different surgeons with different techniques. One of the evolving techniques is clipless laparoscopic cholecystectomy where the division of cystic duct is undertaken using a vessel sealing device (ultrasonic device). Given that one of the concerns adopting this technique is the risk of bile leak, you wonder whether it has a higher risk compared to conventional cholecystectomy. Therefore, you decide to conduct a systematic review to look for a based evidence answer to this question.

Three-part question
In [patients undergoing cholecystectomy] is [the clipless laparoscopic cholecystectomy] associated with [higher rates of bile leak compared to conventional cholecystectomy]?

Search strategy
The search was conducted as following: Embase 1974 to 2020 and MEDLINE® 1946 to November 2020 using the OVID interface.
[ The search was limited to English language and human studies.

Search outcome
7304 articles were found. Out of these 7 deemed to be suitable and met the criteria of our search after removing the duplicate and excluding the irrelevant articles. 6 out of 7 articles were chosen as they compared the bile leak rates between the two techniques ( Fig. 1).

Exclusion criteria
1 Studies not comparing both techniques 2 Conference abstracts 3 Low evidence papers 4 Absence of full-text articles

Result
(please refer to the Table 1)

Discussion
In 2008, Bessa et al. [2] conducted a randomized controlled study comparing clipless laparoscopic cholecystectomy versus conventional technique in terms of safety and bile leak. The authors included 120 patients with symptomatic gallstone disease who were randomly assigned to either the harmonic scalpel laparoscopic cholecystectomy group (HS group = 60 patients) where closure and division of the cystic duct was achieved solely by the harmonic shears or the clip and cautery laparoscopic cholecystectomy group (C&C group = 60 patients). They have reported no minor or major bile leaks in either groups and concluded that harmonic shears are as safe and effective as the commonly used clip and cautery technique in achieving safe closure and division of the cystic duct in the laparoscopic cholecystectomy.
In 2009, Kandil et al. [3] devised a randomized controlled trial. The study included 140 patients who were randomized into two groups. Group A included 70 patients in whom laparoscopic cholecystectomy was conducted using the traditional method by clipping both cystic duct and artery and dissection of gallbladder from liver bed by diathermy. Group B included 70 patients where laparoscopic cholecystectomy was conducted using harmonic scalpel. Closure and division of both cystic duct and artery and dissection of gallbladder from liver bed by harmonic scalpel. They have found no statistical difference in intraoperative and postoperative bile leak between the two groups. Intraoperative bile spillage was 13(18.6%) in group A and 5 (7.1%) in group B (P = 0.04). Postoperative bile leakage was 2 (2.9%) in group A and 0 in group B (P = 0.156). The authors concluded that clipless cholecystectomy provides a complete biliary stasis and is a safe alternative to the standard cholecystectomy.
In 2010, Nakeeb et al. [4] conducted a similar study which included 120 patients. They found that bile leak was encountered in 1.7% with  clipless cholecystectomy compared to 3.3% with traditional cholecystectomy (p = 0.45). The authors concluded that the Harmonic scalpel provides complete biliary stasis and is a safe alternative to the standard clipping of the cystic duct. Jain et al. [5] in 2011 conducted another randomized controlled trial which included 200 patients and there was no incidence of bile leak during a 6-month follow-up period in either of the groups.
Wills et al. [6] in 2013 conducted a retrospective cohort study which included 208 patients. Out of these 57 were done using clipless technique. They found that the use of the Harmonic scalpel versus clip placement had comparable rates of bile leak at 1.75% and 0.66%, respectively.
Lastly in 2017, Sanawan et al. [7] conducted a randomized controlled trial which included 150 patients who were randomized into two groups. Half of them underwent clipless cholecystectomy and the other half underwent conventional cholecystectomy. The authors found that none of the patients in either group had bile leaks.
The observed limitation to all of the abovementioned studies is the risk of bias.

Clinical bottom line
All of the abovementioned studies have found comparable rates of bile leaks between clipless and conventional laparoscopic cholecystectomy. Therefore, it appears that the clipless laparoscopic cholecystectomy is a safe and feasible technique.

Ethical approval
Not applicable.

Sources of funding
None.

Declaration of competing interestCOI
None.