• Manabu Kawai, Seiko Hirono, Ken-Ichi Okada, Masayuki Sho, Yoshiyuki Nakajima, Hidetoshi Eguchi, Hiroaki Nagano, Hisashi Ikoma, Ryou Morimura, Yutaka Takeda, Shin Nakahira, Kazuhiro Suzumura, Jiro Fujimoto, and Hiroki Yamaue.
• *Second Department of Surgery, Wakayama Medical University, Wakayama, Japan †Department of Surgery, Nara Medical University, Nara, Japan ‡Department of Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan §Division of Digestive Surgery, Department of Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan ||Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan ¶Department of Hepato-Biliary-Pancreatic Surgery, Hyogo College of Medicine, Hyogo, Japan.
• Ann. Surg. 2015 Sep 29.

ObjectivesThe aim of this study was to evaluate in a multicenter randomized controlled trial (RCT) whether pancreaticojejunostomy (PJ) of pancreatic stump decreases the incidence of pancreatic fistula after distal pancreatectomy (DP) compared with stapler closure.BackgroundSeveral studies reported that PJ of pancreatic stump reduces the incidence of pancreatic fistula after DP. However, no RCT has confirmed the efficacy of PJ of pancreatic stump.MethodsOne hundred thirty-six patients scheduled for DP were enrolled in this study between June 2011 and March 2014 at 6 high-volume surgical centers in Japan. Enrolled patients were randomized to either stapler closure or PJ. The primary endpoint was the incidence of pancreatic fistula based on the International Study Group on Pancreatic Fistula criteria. This RCT was registered with ClinicalTrials.gov (NCT01384617).ResultsSixty-one patients randomized to stapler and 62 patients randomized to PJ were analyzed by intention-to-treat. Pancreatic fistula occurred in 23 patients (37.7%) in the stapler closure group and 24 (38.7%) in the PJ group (P = 0.332) in intention-to-treat analysis. The incidence of clinically relevant pancreatic fistula (grade B or C) was 16.4% for stapler closure and 9.7% for PJ (P = 0.201). Mortality was zero in both groups. In a subgroup analysis for thickness of pancreas greater than 12 mm, the incidence of clinically relevant pancreatic fistula occurred in 22.2% of the patients in the stapler closure group and in 6.2% of the PJ group (P = 0.080).ConclusionsPJ of the pancreatic stump during DP does not reduce pancreatic fistula compared with stapler closure.

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