title: Delayed Gastric Emptying After Stapled Versus Hand-Sewn Anastomosis of Duodenojejunostomy in Pylorus-Preserving Pancreaticoduodenectomy: a Randomized Controlled trial.
abstract: BACKGROUND
  A retrospective analysis indicated that the incidence of delayed gastric emptying (DGE) was less after using a circular stapler (CS) for duodenojejunostomy than that after hand-sewn (HS) anastomosis in pylorus-preserving pancreaticoduodenectomy (PpPD). This randomized clinical trial compared the incidence of DGE postoperative after CS duodenojejunostomy with that of conventional HS anastomosis in PpPD.
  
  
  METHODS
  We randomly assigned 101 patients (age 20-80) undergoing PpPD to receive CS duodenojejunostomy (group CS, n = 50) or HS duodenojejunostomy (group HS, n = 51) in two Japanese cancer center hospitals between 2011 and 2013. The patients were stratified by institution and size of the main pancreatic duct (<3 or ≥3 mm). The primary endpoint was the incidence of grade B or C DGE according to the international definition with a non-inferiority margin of 5 %. This trial is registered with University hospital Medical Information Network (UMIN) Center: UMIN000005463.
  
  
  RESULTS
  Per-protocol analysis of data on 95 patients showed that grade B or C DGE was found in 4 (8.9 %) of 45 patients who underwent CS anastomosis and in 8 (16 %) of 50 patients who underwent HS anastomosis (P = 0.015). There were no differences in the overall incidence of DGE (P = 0.98), passage of the contrast medium through the anastomosis (P = 0.55), or hospital stays (P = 0.22).
  
  
  CONCLUSIONS
  CS duodenojejunostomy is not inferior to HS anastomosis with respect to the incidence of clinically significant DGE, justifying its use as treatment option.
authors.affiliation: Hepato-Biliary-Pancreatic Surgery Division, Artificial Organ and Transplantation Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. yosakamo-tky@umin.ac.jp.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Sakamoto
authors.affiliation: Hepatobiliary and Pancreatic Surgery Division, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
authors.forename: Shutaro
authors.initials: S
authors.lastname: Hori
authors.affiliation: Hepatobiliary and Pancreatic Surgery Division, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
authors.forename: Seiji
authors.initials: S
authors.lastname: Oguro
authors.affiliation: Department of Gastrointestinal Surgery, Cancer Institute Ariake Hospital, Japanese Foundation for Cancer Research, Koto-ku, Tokyo, Japan.
authors.forename: Junichi
authors.initials: J
authors.lastname: Arita
authors.affiliation: Hepatobiliary and Pancreatic Surgery Division, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
authors.forename: Yoji
authors.initials: Y
authors.lastname: Kishi
authors.affiliation: Hepatobiliary and Pancreatic Surgery Division, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Nara
authors.affiliation: Hepatobiliary and Pancreatic Surgery Division, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
authors.forename: Minoru
authors.initials: M
authors.lastname: Esaki
authors.affiliation: Department of Gastrointestinal Surgery, Cancer Institute Ariake Hospital, Japanese Foundation for Cancer Research, Koto-ku, Tokyo, Japan.
authors.forename: Akio
authors.initials: A
authors.lastname: Saiura
authors.affiliation: Hepatobiliary and Pancreatic Surgery Division, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Shimada
authors.affiliation: Department of Bioethics, Yokohama City University, Yokohama, Japan.
authors.forename: Takeharu
authors.initials: T
authors.lastname: Yamanaka
authors.affiliation: Hepatobiliary and Pancreatic Surgery Division, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
authors.forename: Tomoo
authors.initials: T
authors.lastname: Kosuge
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004379:Duodenal Neoplasms / Q000473:pathology / Q000601:surgery; D004385:Duodenostomy / Q000009:adverse effects*; D005260:Female; D018589:Gastroparesis / Q000453:epidemiology*; D006801:Humans; D015994:Incidence; D007582:Jejunostomy / Q000009:adverse effects*; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000473:pathology / Q000601:surgery*; D016577:Pancreaticoduodenectomy / Q000009:adverse effects*; D017792:Surgical Stapling / Q000009:adverse effects*; D013997:Time Factors; D055815:Young Adult
keywords: Circular stapler; Delayed gastric emptying; Hand-sewn; Pylorus-preserving pancreaticoduodenectomy; Randomized controlled trial