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the Safety of Stapler Versus Non-Stapler Closure of the Pancreatic Remnant After Distal Pancreatectomy: a Multicenter Randomized Controlled Trial
Kazuaki Shimada^*1, Masaru Konishi², Akio Saiura³, Tsuyoshi Sano⁴, Masashi Hashimoto⁵, Katsuhiko Uesaka⁶, Yoshihiro Sakamoto⁷, Takeharu Yamanaka<sup>8

1</sup>Hepatobiliary and pancreatic surgery, National Cancer Center Hospital, Tokyo, Japan; ²Hepatobiliary and pancreatic surgery, National Cancer Center Hospital East, Matsudo, Japan; ³Hepatobiliary and pancreatic surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan; ⁴Gastroenterological Surgery, AIchi Medical University, Nagahisate, Japan; ⁵Digestive Surgery, Toranomon Hospital, Tokyo, Japan; ⁶Hepato-Biliary-Pancreatic Surgery, Shizuoka Cancer Center Hospital, Mishima, Japan; ⁷Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; ⁸Department of Biostatistics, Graduate school of Medicine, Yokohama City University, Kanagawa, Japan

Objective: The objective of this study was to assess whether stapler closure after distal pancreatectomy has equivalent safety in the incidence of clinical pancreatic fistula to non-stapler closure, because a stapler technique may be more convenient and faster to perform. Stapler closure has been widely applied along with the recent introduction of laparoscopic distal pancreatectomy. However, stapler closure of the pancreatic remnant has not always reduced the incidence of pancreatic fistula compared with non-stapler closure.
Methods: A multicenter, randomized, controlled, non-inferiority trial was conducted at five hospitals. Patients undergoing distal pancreatectomy were assigned by central randomization after laparotomy to either stapler or non-stapler closure of the pancreatic remnant. The primary endpoint was the incidence of Grade B or C pancreatic fistula. The final analysis was performed per-protocol in all patients undergoing distal pancreatectomy. This trial was registered with University hospital Medical Information Network (UMIN) Center (registration ID: UMIN000004838).
Results: From January 18, 2011 to August 30, 2013, 141 patients were enrolled and randomly assigned to stapler closure (n=73) or non-stapler closure (n=68). One hundred and thirty-four patients, consisting of 68 with stapler closure and 66 with non-stapler closure, were analyzed. Grade B or C pancreatic fistulas occurred in 34 patients (50%) in the stapler closure group and 27 (41%) in the non-stapler group (absolute risk reduction, -0.09; 95%CI, -0.25 to 0.08; P=0.38) The rate of severe adverse complications were similar for both closure techniques.
Conclusion: As stapler closure did not result in a non-inferior rate of clinical pancreatic fistula, non-stapler closure might be considered as a standard procedure.

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