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Randomized Trial of the Usefulness of a Bile Leakage Test During Hepatic Resection
Masayoshi Ijichi, MD;
Tadatoshi Takayama, MD, PhD;
Hiroyuki Toyoda, MD;
Keiji Sano, MD;
Keiichi Kubota, MD, PhD;
Masatoshi Makuuchi, MD, PhD
Arch Surg. 2000;135:1395-1400.
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 µmol/L or more ( 5 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.
From the Division of Hepato-Biliary-Pancreatic and Transplantation Surgery, Second Department of Surgery, Faculty of Medicine, University of Tokyo, Tokyo, Japan.
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