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

作者：Park Joon Seong; Lee Doo ho; Jang Jin Young^*; Han Youngmin; Yoon Dong Sup; Kim Jae Keun; Han Ho Seong; Yoon YooSeok; Hwang DaeWook; Kang Chang Moo; Hwang Ho Kyoung; Lee Woo Jung; Heo JinSeok; Chang Ye Rim; Kang Mee Joo; Shin Yong Chan; Chang Jihoon; Kim Hongbeom; Jung Woohyun; Kim Sun Whe

来源：Journal of Hepato-Biliary-Pancreatic Sciences, 2016, 23(2): 110-117.

DOI：10.1002/jhbp.310

• Distal pancreatectomy
• Postoperative pancreatic fistula
• Prevention

BackgroundWe performed a prospective, multicenter, randomized controlled study to investigate the clinical outcomes, including postoperative pancreatic fistulas (POPF), after using the TachoSil (R) patch in distal pancreatectomy (NCT01550406).
MethodsBetween 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.
ResultsThe patient characteristics, including age and diagnosis, were comparable in both groups. The mean operation time (159.4 vs. 172.3min, P=0.081) and postoperative hospital stay (10.0 vs. 9.7days, 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).
ConclusionThis study showed that the TachoSil (R) patch did not reduce the incidence of POPF after distal pancreatectomy.

• 出版日期2016-2