TY - JOUR
T1 - Use of TachoSil® patches to prevent pancreatic leaks after distal pancreatectomy
T2 - A prospective, multicenter, randomized controlled study
AU - Park, Joon Seong
AU - Lee, Doo Ho
AU - Jang, Jin Young
AU - Han, Youngmin
AU - Yoon, Dong Sup
AU - Kim, Jae Keun
AU - Han, Ho Seong
AU - Yoon, Yooseok
AU - Hwang, Daewook
AU - Kang, Chang Moo
AU - Hwang, Ho Kyoung
AU - Lee, Woo Jung
AU - Heo, Jinseok
AU - Chang, Ye Rim
AU - Kang, Mee Joo
AU - Shin, Yong Chan
AU - Chang, Jihoon
AU - Kim, Hongbeom
AU - Jung, Woohyun
AU - Kim, Sun Whe
N1 - Funding Information:
This research was supported by a Korea HealthTechnology R&D Project grant from the Korea Health Industry DevelopmentInstitute (KHIDI), funded by the Ministry of Health & Welfare(HI14C2640) and Seoul National University Hospital (no. 04?2014-0530).
Publisher Copyright:
© 2015 Japanese Society of Hepato-Biliary-Pancreatic Surgery.
PY - 2016/2/1
Y1 - 2016/2/1
N2 - 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. Highlight The authors performed a prospective, multicenter, ramdomized controlled study to investigate the efficacy of TachoSil® patches in preventing pancreatic fistula, the most frequent and serious complication after distal pancreatectomy, for which effective prevention and management methods remain lacking. The patch did not reduce the incidence of postoperative pancreatic fistula.
AB - 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. Highlight The authors performed a prospective, multicenter, ramdomized controlled study to investigate the efficacy of TachoSil® patches in preventing pancreatic fistula, the most frequent and serious complication after distal pancreatectomy, for which effective prevention and management methods remain lacking. The patch did not reduce the incidence of postoperative pancreatic fistula.
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U2 - 10.1002/jhbp.310
DO - 10.1002/jhbp.310
M3 - Article
C2 - 26681272
AN - SCOPUS:84957678051
VL - 23
SP - 110
EP - 117
JO - Journal of Hepato-Biliary-Pancreatic Sciences
JF - Journal of Hepato-Biliary-Pancreatic Sciences
SN - 1868-6974
IS - 2
ER -