Randomized trial of the usefulness of a bile leakage test during hepatic resection

Hypothesis: An intraoperative bile leakage test Will assist in decreasing postoperative bile leakage in patients undergoing hepatic resection. Design: Randomized controlled trial. Setting: University hospital. Patients: One hundred three consecutive patients who were scheduled for hepatic resection without biliary reconstruction. Associated cirrhosis was present in 49 patients (48%), and only 24 (23%) had normal livers. Patients were randomized to undergo (n=51) or to not undergo (n=52) a bile leakage test, according to age,liver function, and hepatectomy method. The 2 groups were similar in baseline demographics. Intervention: A bile leakage test was carried out by injecting isotonic sodium chloride solution through the cystic duct, and interrupted suturing was taken for a bile leak on the transected liver surface. Main Outcome Measures: The incidence of postoperative bile leakage and the length of the postoperative hospital stay. Bile leakage was defined as continuous drainage, with a bilirubin level of 86 mu mol/L or more (greater than or equal to5 mg/dL), beyond 1 week. Results: Twenty-one patients (41%) in the test group showed a bile leak, and a median of 1 site (range, 1-6 sites) was closed during the test. Postoperative bile leakage was observed in 3 patients (6%) in the test group and in 2 (4%) in the control group (P=.99). The odds ratio of the event was 1.53 (95% confidence interval, 0.25-9.44). The median postoperative hospital stay lasted 17 (range, 13-47) and 18 (range, 12-41) days for the test and control groups, respectively (P=.98). Conclusion: This randomized trial suggested no advantage in using a bile leakage test during hepatic resection.