A comparative study of 10-Fr vs. 7-Fr straight plastic stents in the treatment of postcholecystectomy bile leak

Background: Biliary decompression is a key factor in the treatment of postcholecystectomy bile leak. However, the optimal size of the stent introduced by therapeutic endoscopic retrograde cholangiopancreatography (ERCP) is yet to be determined. The aim of the study was to compare the effectiveness of two straight plastic stents with different sizes (10-Fr and 7-Fr) in the treatment of postcholecystectomy bile leak. Methods: Between January 2003 and August 2006, 63 patients underwent therapeutic ERCP for postcholecystectomy bile leak. After visualization of the bile duct injury, endoscopic sphincterotomy was performed and the patients were randomized to receive either a 7-Fr (31 subjects, group A) or a 10-Fr (32 subjects, group B) straight plastic stent for four weeks. The success of the endoscopic treatment was determined by the elimination of the symptoms and the removal of the drain without any adverse outcomes. Results: The endoscopic intervention was successful in 29 patients of group A (93.54%) and in 31 patients of group B (96.87%). In the remaining two patients of group A, the 7-Fr stent was substituted by a 10-Fr stent after 7 days because the leak remained unaffected, resulting in healing of the leaks. Surgery was required in the remaining one patient of group B. Eight patients developed post-ERCP pancreatitis (5 mild, 2 moderate, 1 severe), which was treated conservatively. Conclusions: This trial suggests that the stent size does not affect the outcome of the endoscopic intervention in postcholecystectomy bile leaks due to minor biliary tract injury; however, larger cohorts are required to confirm the optimal stent size in bile leaks due to major bile duct injury.