Bile leak after cholecystectomy significance and treatment: results from the National Norwegian Cholecystectomy Registry.

From April 1993 to July 1995, altogether 3860 procedures were enrolled in the Norwegian National Cholecystectomy Registry (NNCR), 777 (20.2%) being open operations. 3083 (79.8%) were initiated laparoscopically, 313 (10.2%) of these converted to open technique. Mortality within 30 days after open cholecystectomy was 1.9%, after a converted procedure 1.0% and 0.14% after laparoscopic cholecystectomy (p<0.01). According to the intention to treat principle, converted procedures should be included in the laparoscopic group. This gives seven deaths after 3083 procedures, i.e. 0.23%. Postoperative death still occurs approximately 10 times more frequently after open cholecystectomy (p<0.01). However, this is partly due to selection of high risk cases to open technique. Postoperative bile leak was observed in 25 patients (0.9%) in the laparoscopic, 13 (4.2%) in the converted and 19 (2.4%) in the open group. Bile leak contributed significantly to serious complications. 37 major problems were observed in 25 of the patients (44%). Five patients died (8.8%). Among the 57 bile leak patients, common bile duct (CBD) injury was found in 13 (22.8%). Additional 19 CBD injuries occurred, presenting with other symptoms such as icterus, or being recognised during the first operation. The frequency of CBD injury in the laparoscopic group was 14 (0.5%), in the converted group 12 (3.8%) and in the open group 6 (0.8%). None of the patients with CBD injury underwent intraoperative cholangiography. The present results firstly show that open cholecystectomy cannot be considered a safe procedure for high risk patients, secondly, that postoperative bile leak contributes significantly to postoperative mortality and hence is a serious condition generating from CBD injury in about 1/5 of all cases.