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.
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Acknowledgments
The authors express deep gratitude to Dr. Katsuhiko Uesaka, Department of Hepato-Biliary-Pancreatic Surgery, Shizuoka Cancer Center Hospital, Dr. Masaru Konishi and Dr. Naoto Gotohda, Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital East, and Dr. Masaji Hashimoto, Department of Digestive Surgery, Toranomon Hospital, for their critical review of the trial design and manuscripts.
This work is supported in part by Grant-in-Aid for scientific research from the Ministry of Health and Welfare of Japan.
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The authors declare that they have no competing interests.
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Sakamoto, Y., Hori, S., Oguro, S. et al. Delayed Gastric Emptying After Stapled Versus Hand-Sewn Anastomosis of Duodenojejunostomy in Pylorus-Preserving Pancreaticoduodenectomy: a Randomized Controlled trial. J Gastrointest Surg 20, 595–603 (2016). https://doi.org/10.1007/s11605-015-2961-6
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DOI: https://doi.org/10.1007/s11605-015-2961-6