title: Effect of Polyglycolic Acid Mesh for Prevention of Pancreatic Fistula Following Distal Pancreatectomy: A Randomized Clinical Trial.
abstract: The rate of postoperative pancreatic fistula (POPF) after distal pancreatectomy ranges from 13% to 64%. To prevent POPF, polyglycolic acid (PGA) mesh was introduced, but its effect has been evaluated only in small numbers of patients and retrospective studies.
  
  
  
  To evaluate the efficacy of PGA mesh in preventing POPF after distal pancreatectomy.
  
  
  
  Prospective randomized clinical, single-blind (participant), parallel-group trial at 5 centers between November 2011 and April 2014. The pancreatic parenchyma was divided using a stapling device; no patient was given prophylactic octreotide. Perioperative and clinical outcomes were compared including POPF, which was graded according to the criteria of the International Study Group For Pancreatic Fistulas. A total of 97 patients aged 20 to 85 years with curable benign, premalignant, or malignant disease of the pancreatic body or tail were enrolled (44 in the PGA group and 53 in the control group).
  
  
  
  Patients in the PGA group underwent transection of the pancreas and application of fibrin glue followed by wrapping the PGA mesh around the remnant pancreatic stump.
  
  
  
  The primary end point of this study was the development of a clinically relevant POPF (grade B or C by the International Study Group grading system). The secondary end point was the evaluation of risk factors for POPF.
  
  
  
  The study therefore evaluated a total of 97 patients, 44 in the PGA group and 53 in the control group. Thirty-nine patients were women and 58 patients were men. There were no differences in mean (SD) age (59.9 [12.0] years vs 54.5 [14.1] years, P = .05), male to female ratio (1.0:1.3 vs 1.0:1.7, P = .59), malignancy (40.9% vs 32.1%, P = .37), mean (SD) pancreatic duct diameter (1.92 [0.75] mm vs 1.94 [0.95] mm, P = .47), soft pancreatic texture (90.9% vs 83.0%, P = .17), and mean (SD) thickness of the transection margin (16.9 [5.4] mm vs 16.4 [4.9] mm, P = .63) between the PGA and control groups. The rate of clinically relevant POPF (grade B or C) was significantly lower in the PGA group than in the control group (11.4% vs 28.3%, P = .04).
  
  
  
  Wrapping of the cut surface of the pancreas with PGA mesh is associated with a significantly reduced rate of clinically relevant POPF.
  
  
  
  clinicaltrials.gov Identifier: NCT01550406.
authors: Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors: Jin-Young
authors: JY
authors: Jang
authors: Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea2Department of Surgery, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.
authors: Yong Chan
authors: YC
authors: Shin
authors: Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors: Youngmin
authors: Y
authors: Han
authors: Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors: Joon Seong
authors: JS
authors: Park
authors: Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
authors: Ho-Seong
authors: HS
authors: Han
authors: Department of Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors: Ho Kyoung
authors: HK
authors: Hwang
authors: Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors: Dong Sup
authors: DS
authors: Yoon
authors: Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors: Jae Keun
authors: JK
authors: Kim
authors: Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
authors: Yoo Seok
authors: YS
authors: Yoon
authors: Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
authors: Dae Wook
authors: DW
authors: Hwang
authors: Department of Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors: Chang Moo
authors: CM
authors: Kang
authors: Department of Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors: Woo Jung
authors: WJ
authors: Lee
authors: Department of Surgery, Samsung Medical Center, Sungkyunkwan University College of Medicine, Seoul, Korea.
authors: Jin Seok
authors: JS
authors: Heo
authors: Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors: Mee Joo
authors: MJ
authors: Kang
authors: Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors: Ye Rim
authors: YR
authors: Chang
authors: Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors: Jihoon
authors: J
authors: Chang
authors: Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors: Woohyun
authors: W
authors: Jung
authors: Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
authors: Sun-Whe
authors: SW
authors: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D021441:Carcinoma, Pancreatic Ductal / Q000601:surgery*; D003537:Cystadenoma / Q000601:surgery*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010180:Pancreatectomy / Q000009:adverse effects* / Q000379:methods; D010185:Pancreatic Fistula / Q000209:etiology / Q000517:prevention & control*; D010190:Pancreatic Neoplasms / Q000601:surgery*; D011100:Polyglycolic Acid / Q000627:therapeutic use*; D011230:Precancerous Conditions / Q000601:surgery*; D011446:Prospective Studies; D016037:Single-Blind Method; D013526:Surgical Mesh; D055815:Young Adult
chemical_list: D011100:Polyglycolic Acid