Junichi Arita1, Kentaro Sakamaki2, Akio Saiura3, Masaru Konishi4, Yoshihiro Sakamoto5, Masaji Hashimoto6, Tsuyoshi Sano7, Katsuhiko Uesaka8, Norihiro Kokudo9, Takeharu Yamanaka10, Kazuaki Shimada11. 1. Hepato-Biliary and Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan. 2. Center for Data Science, Yokohama City University, Yokohama, Japan. 3. Department of Gastrointestinal Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan. 4. Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital East, Chiba, Japan. 5. Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Kyorin University School of Medicine, Tokyo, Japan. 6. Hepato-Biliary-Pancreatic Surgery Division, Department of Gastroenterological Surgery, Toranomon Hospital, Tokyo, Japan. 7. Department of Surgery, Division of Gastroenterological Surgery, Aichi Medical University, Nagakute, Japan. 8. Division of Hepato-Biliary-Pancreatic Surgery, Shizuoka Cancer Center, Shizuoka, Japan. 9. National Center for Global Health and Medicine, Tokyo, Japan. 10. Department of Biostatistics, School of Medicine, Yokohama City University, Yokohama, Japan. 11. Hepatobiliary and Pancreatic Surgery Division, National Cancer Center Hospital, Tokyo, Japan.
Abstract
OBJECTIVE: To assess the clinical impact of a no-drain policy after hepatic resection. SUMMARY OF BACKGROUND DATA: Previous randomized controlled trials addressing no-drain policy after hepatic resection seem inconclusive because they did not adopt appropriate study design to validate its true clinical impact. METHODS: This unblinded, randomized controlled trial was done at 7 Japanese institutions. Patients undergoing hepatic resection without biliary reconstruction were randomized to either D group or ND group. When the risk of postoperative bile leakage or hemorrhage were considered high, the patients were excluded during the operation. Primary endpoint was the postoperative complication of C-D grade 3 or higher within 90 postoperative days. A noninferiority of ND group to D group was assessed, and if it was confirmed, a superiority was assessed. RESULTS: Between May 2015 and July 2017, a total of 400 patients were finally included in the per-protocol set analysis: 199 patients in D group and 201 patients in ND group. Intraoperatively, 37 patients were excluded from the final enrollment because of high risk of bile leakage or hemorrhage. Postoperative complication rate of C-D grade 3 or higher was 8.0% (16/199) in the D group and 2.5% (5/201) in the ND group. The risk difference was -5.5% (95% confidence interval: -9.9% to -1.2%) and fulfilled the prescribed noninferiority margin of 4%. No postoperative mortality was experienced in both groups. Bile leakage was diagnosed in 8.0% (16/199) of the D group and none in the ND group (P < 0.001). In none of the subgroups classified based on 8 potentially relevant factors, drain placement was favored in terms of C-D grade 3 or higher complication. CONCLUSIONS: Drains should not be placed after uncomplicated hepatic resections.
OBJECTIVE: To assess the clinical impact of a no-drain policy after hepatic resection. SUMMARY OF BACKGROUND DATA: Previous randomized controlled trials addressing no-drain policy after hepatic resection seem inconclusive because they did not adopt appropriate study design to validate its true clinical impact. METHODS: This unblinded, randomized controlled trial was done at 7 Japanese institutions. Patients undergoing hepatic resection without biliary reconstruction were randomized to either D group or ND group. When the risk of postoperative bile leakage or hemorrhage were considered high, the patients were excluded during the operation. Primary endpoint was the postoperative complication of C-D grade 3 or higher within 90 postoperative days. A noninferiority of ND group to D group was assessed, and if it was confirmed, a superiority was assessed. RESULTS: Between May 2015 and July 2017, a total of 400 patients were finally included in the per-protocol set analysis: 199 patients in D group and 201 patients in ND group. Intraoperatively, 37 patients were excluded from the final enrollment because of high risk of bile leakage or hemorrhage. Postoperative complication rate of C-D grade 3 or higher was 8.0% (16/199) in the D group and 2.5% (5/201) in the ND group. The risk difference was -5.5% (95% confidence interval: -9.9% to -1.2%) and fulfilled the prescribed noninferiority margin of 4%. No postoperative mortality was experienced in both groups. Bile leakage was diagnosed in 8.0% (16/199) of the D group and none in the ND group (P < 0.001). In none of the subgroups classified based on 8 potentially relevant factors, drain placement was favored in terms of C-D grade 3 or higher complication. CONCLUSIONS: Drains should not be placed after uncomplicated hepatic resections.