Kawai Manabu, Hirono Seiko, Okada Ken-Ichi, Sho Masayuki, Nakajima Yoshiyuki, Eguchi Hidetoshi, Nagano Hiroaki, Ikoma Hisashi, Morimura Ryou, Takeda Yutaka, Nakahira Shin, Suzumura Kazuhiro, Fujimoto Jiro, Yamaue Hiroki
*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. 2016 Jul;264(1):180-7. doi: 10.1097/SLA.0000000000001395.
The 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.
Several 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.
One 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).
Sixty-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).
PJ of the pancreatic stump during DP does not reduce pancreatic fistula compared with stapler closure.
本研究旨在通过一项多中心随机对照试验（RCT）评估胰腺残端胰肠吻合术（PJ）与吻合器闭合相比，是否能降低胰体尾切除术（DP）后胰瘘的发生率。
多项研究报告称，胰腺残端PJ可降低DP后胰瘘的发生率。然而，尚无RCT证实胰腺残端PJ的疗效。
2011年6月至2014年3月期间，日本6家大型外科中心的136例计划行DP的患者纳入本研究。纳入患者被随机分为吻合器闭合组或PJ组。主要终点是基于国际胰腺瘘研究组标准的胰瘘发生率。该RCT已在ClinicalTrials.gov注册（NCT01384617）。
按意向性分析，61例随机分配至吻合器闭合组和62例随机分配至PJ组的患者进行了分析。在意向性分析中，吻合器闭合组23例患者（37.7%）发生胰瘘，PJ组24例患者（38.7%）发生胰瘘（P = 0.332）。临床相关胰瘘（B级或C级）的发生率，吻合器闭合组为16.4%，PJ组为9.7%（P = 0.201）。两组死亡率均为零。在胰腺厚度大于12mm的亚组分析中，吻合器闭合组22.2%的患者发生临床相关胰瘘，PJ组6.2%的患者发生临床相关胰瘘（P = 0.080）。
与吻合器闭合相比，DP期间胰腺残端PJ并不能降低胰瘘发生率。
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