Drain Placement After Uncomplicated Hepatic Resection Increases Severe Postoperative Complication Rate: A Japanese Multi-institutional Randomized Controlled Trial (ND-trial)

Ann Surg. 2021 Feb 1;273(2):224-231. doi: 10.1097/SLA.0000000000004051.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Drainage / adverse effects*
  • Female
  • Hepatectomy / adverse effects*
  • Humans
  • Japan
  • Length of Stay
  • Liver Neoplasms / complications
  • Liver Neoplasms / pathology
  • Liver Neoplasms / surgery*
  • Male
  • Middle Aged
  • Operative Time
  • Postoperative Care / adverse effects*
  • Postoperative Complications / epidemiology*
  • Prospective Studies
  • Treatment Outcome
  • Young Adult