Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea; Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
Journal of Hepato-Biliary-Pancreatic Sciences. 2016;23((2)):110-7.
BACKGROUND/PURPOSE We performed a prospective, multicenter, randomized controlled study to investigate the clinical outcomes, including POPF, after using the TachoSil(R) patch in distal pancreatectomy (NCT01550406). METHODS Between June 2012 and September 2014, 101 patients at 5 centers were randomized into Control (n = 53) and TachoSil (n = 48) groups. In all patients, the pancreas was resected using a stapler
with Endo-GIA staples. The TachoSil patch was wrapped around the pancreatic stump only in the TachoSil group, not in Control group. RESULTS The patient characteristics, including age and diagnosis, were comparable in both groups. The mean operation time (159.4 vs 172.3 min, P = 0.081) and postoperative hospital stay (10.0 vs 9.7 days, P = 0.279) were similar in the Control and TachoSil groups, respectively. The overall incidence of POPF was 62.4% (n = 63). The distribution of grades A, B, and C POPF was similar in the Control (14/14/1) and TachoSil (23/11/0) groups, as were the overall incidence (54.7% vs 70.8%, P = 0.095) and the incidence of grade B and C POPF (28.3% vs 22.9%, P = 0.536). CONCLUSION This study showed that the TachoSil patch did not reduce the incidence of POPF after distal pancreatectomy. This article is protected by copyright. All rights reserved.
