Use of TachoSil(®) patches to prevent pancreatic leaks after distal pancreatectomy: a prospective, multicenter, randomized controlled study

Abstract

Background: We performed a prospective, multicenter, randomized controlled study to investigate the clinical outcomes, including postoperative pancreatic fistulas (POPF), after using the TachoSil® patch in distal pancreatectomy (NCT01550406).

Methods: Between June 2012 and September 2014, 101 patients at five 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 (n = 14/14/1) and TachoSil (n = 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.

Keywords: Distal pancreatectomy; Postoperative pancreatic fistula; Prevention.