Bile leakage and the number of metal clips on the cystic duct during laparoscopic cholecystectomy

Background and objective: The most common way of closing the cystic duct in laparoscopic cholecystectomy is by using metal clips (>80%). Nevertheless, bile leakage occurs in 0.4%-2.0% of cases, and thus causes significant morbidity. However, the optimal number of clips needed to avoid bile leakage has not been determined. The primary aim of this study was to evaluate bile leakage and post-procedural adverse events after laparoscopic cholecystectomy concerning whether two or three clips were used to seal the cystic duct. Methods: Using a retrospective observational design, we gathered data from the Swedish Registry for Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography (ERCP) (GallRiks). From 2006 until 2019, 124,818 patients were eligible for inclusion. These were nested to cohorts of 75,322 (60.3%) for uncomplicated gallstone disease and 49,496 (39.7%) with complicated gallstone disease. The cohorts were grouped by the number (i.e. two or three) of metal clips applied to the proximal cystic duct. The main outcome was 30-day bile leakage and post-procedural adverse events. Results: No significant differences surfaced in the rate of bile leakage (0.8% vs 0.8%; P = .87) or post-procedural adverse events (three clips, 5.7% vs two clips, 5.4%; P = .16) for uncomplicated gallstone disease. However, for complicated disease, bile leakage (1.4% vs 1.0%; P < .001) and post-procedural adverse events (10.2% vs 8.6%; P < .001) significantly increased when the cystic duct was sealed with three clips compared with two. Conclusions: Because no differences in the rates of bile leakage or adverse events emerged in uncomplicated gallstone disease when a third clip was applied, a third clip for additional safety is not recommended in such cases. On the contrary, bile leakage and adverse events increased when a third clip was used in patients with complicated gallstone disease. This finding probably indicates a more difficult cholecystectomy rather than being caused by the third clip itself.