Yoshihiro Sakamoto1, Shutaro Hori2, Seiji Oguro2, Junichi Arita3, Yoji Kishi2, Satoshi Nara2, Minoru Esaki2, Akio Saiura3, Kazuaki Shimada2, Takeharu Yamanaka4, Tomoo Kosuge2. 1. 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. 2. Hepatobiliary and Pancreatic Surgery Division, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan. 3. Department of Gastrointestinal Surgery, Cancer Institute Ariake Hospital, Japanese Foundation for Cancer Research, Koto-ku, Tokyo, Japan. 4. Department of Bioethics, Yokohama City University, Yokohama, Japan.
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) undergoingPpPD 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.
RCT Entities:
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: Dong K Kim; Alexander A Hindenburg; Sushil K Sharma; Chang Ho Suk; Frank G Gress; Harry Staszewski; James H Grendell; William P Reed Journal: Ann Surg Oncol Date: 2005-03-03 Impact factor: 5.344
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