title: 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).
  
  
  CONCLUSIONS
  This study showed that the TachoSil® patch did not reduce the incidence of POPF after distal pancreatectomy.
authors.affiliation: Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Joon Seong
authors.initials: JS
authors.lastname: Park
authors.affiliation: Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Doo-Ho
authors.initials: DH
authors.lastname: Lee
authors.affiliation: Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Jin-Young
authors.initials: JY
authors.lastname: Jang
authors.affiliation: Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Youngmin
authors.initials: Y
authors.lastname: Han
authors.affiliation: Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Dong Sup
authors.initials: DS
authors.lastname: Yoon
authors.affiliation: Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Jae Keun
authors.initials: JK
authors.lastname: Kim
authors.affiliation: Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
authors.forename: Ho-Seong
authors.initials: HS
authors.lastname: Han
authors.affiliation: Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
authors.forename: YooSeok
authors.initials: Y
authors.lastname: Yoon
authors.affiliation: Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
authors.forename: DaeWook
authors.initials: D
authors.lastname: Hwang
authors.affiliation: Department of Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Chang Moo
authors.initials: CM
authors.lastname: Kang
authors.affiliation: Department of Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Ho Kyoung
authors.initials: HK
authors.lastname: Hwang
authors.affiliation: Department of Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Woo Jung
authors.initials: WJ
authors.lastname: Lee
authors.affiliation: Department of Surgery, Samsung Medical Center, Sungkyunkwan University College of Medicine, Seoul, Korea.
authors.forename: JinSeok
authors.initials: J
authors.lastname: Heo
authors.affiliation: Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Ye Rim
authors.initials: YR
authors.lastname: Chang
authors.affiliation: Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Mee Joo
authors.initials: MJ
authors.lastname: Kang
authors.affiliation: Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Yong Chan
authors.initials: YC
authors.lastname: Shin
authors.affiliation: Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Jihoon
authors.initials: J
authors.lastname: Chang
authors.affiliation: Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Hongbeom
authors.initials: H
authors.lastname: Kim
authors.affiliation: Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Woohyun
authors.initials: W
authors.lastname: Jung
authors.affiliation: Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Sun-Whe
authors.initials: SW
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004338:Drug Combinations; D005260:Female; D005340:Fibrinogen / Q000627:therapeutic use*; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D010179:Pancreas / Q000033:anatomy & histology; D010180:Pancreatectomy; D010185:Pancreatic Fistula / Q000209:etiology / Q000517:prevention & control; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D013917:Thrombin / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D004338:Drug Combinations; C518955:TachoSil; D005340:Fibrinogen; D013917:Thrombin
keywords: Distal pancreatectomy; Postoperative pancreatic fistula; Prevention