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Randomized Clinical Trial of Duct-to-Mucosa Pancreaticogastrostomy of Pancreatic Stump Versus Hand-Sewn Closure After Distal Pancreatectomy
Kenichiro Uemura*1, Sohei Satoi2, Fuyuhiko Motoi3, Yasushi Hashimoto1, Hiroaki Yanagimoto2, Koji Fukase3, Naru Kondo1, Tomohisa Yamamoto2, Yu Katayose3, a-Hon Kwon2, Michiaki Unno3, Yoshiaki Murakami1
1Surgery, Hiroshima University, Hiroshima, Japan; 2Surgery, Kansai Medical University, Osaka, Japan; 3Surgery, Tohoku University, Sendai, Japan
Background: Postoperative pancreatic fistula (POPF) remains the main morbidity after distal pancreatectomy (DP). The aim of this study was to investigate whether duct-to-mucosa pancreaticogastrostomy (PG) of pancreatic stump would decrease clinical POPF compared with a hand-sewn closure (HSC) after DP.
Methods: This multicenter, randomized, control trial was done between April 2012 and June 2014. Patients with pancreatic diseases undergoing DP were randomly assigned by central randomization before surgery to either PG or HSC. Primary endpoint was the incidence of clinical POPF. Secondary endpoints were rate of other complications and hospital stay.
Results: In total of 73 patients were included in the final analysis, 36 patients in the PG and 37 patients in the HSC group. Duration of operation was significantly longer in the PG group than in the HSC group (268 versus 197 min; P<0.001). The incidence of clinical POPF did not differ between PG and HSC (19 versus 19 per cent; p=1.000). Rate of intra-abdominal fluid collection was significantly lower in the PG group than in the HSC group (17 versus 54 per cent; P=0.001).There were no significant difference in the rate of other complication or hospital stay between the groups.
Conclusions: This study demonstrated that PG does not reduce the incidence of clinical POPF compared with HSC. Clinical Study Registration number UMIN000007426 (http://www.umin.ac.jp)
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