The British journal of surgery · 2025
Impact of pre-compression versus non-compression before parenchyma transection in left-sided pancreatic resection on the rate of clinically relevant pancreatic fistula: multicentre randomized clinical trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Sumiyoshi Tatsuaki, Uemura Kenichiro, Seo Shingo, Fujii Tsutomu, Satoi Sohei, Miwa Takeshi, Fukasawa Mina, Yamaki So, Oshita Akihiko, Abe Tomoyuki, Sudo Takeshi, Tazuma Sho, Sasaki Masaru, Matsugu Yasuhiro, Kohashi Toshihiko, Nakashima Akira, Kuroda Shintaro, Oishi Koichi, Inoue Masashi, Okano Keisuke, Matsukawa Hiroyoshi, Ohdan Hideki, Takahashi Shinya
Аннотация
BACKGROUND: Previous retrospective studies have demonstrated the effectiveness of parenchymal pre-compression in reducing pancreatic fistula after left-sided pancreatic resection; however, no multicentre RCT has been conducted. The aim of this study was to investigate whether pre-compression reduces grade B/C pancreatic fistula after left-sided pancreatic resection.
METHODS: Between 23 March 2021 and 26 January 2023, patients scheduled for left-sided pancreatic resection were enrolled in a multicentre RCT at 13 hospitals in Japan. These patients were randomly assigned (1 : 1) to the pre-compression group or the non-compression group. The primary endpoint was the incidence of grade B/C pancreatic fistula and the secondary endpoint was it in the subgroup.
RESULTS: Overall, 180 patients were assigned to the pre-compression group and the non-compression group (92 patients and 88 patients respectively) and 171 patients were analysed (88 patients in the pre-compression group and 83 patients in the non-compression group). Grade B/C pancreatic fistula was observed in 22 patients (12.9%), including 11 of 88 patients (12.5%) in the pre-compression group and 11 of 83 patients (13.3%) in the non-compression group (OR 0.94 (95% c.i. 0.38 to 2.31); P = 0.883).
CONCLUSION: A statistically significant difference in the incidence of grade B/C pancreatic fistula was not observed between the pre-compression group and the non-compression group.
REGISTRATION NUMBER: UMIN000042700 (https://www.umin.ac.jp).
METHODS: Between 23 March 2021 and 26 January 2023, patients scheduled for left-sided pancreatic resection were enrolled in a multicentre RCT at 13 hospitals in Japan. These patients were randomly assigned (1 : 1) to the pre-compression group or the non-compression group. The primary endpoint was the incidence of grade B/C pancreatic fistula and the secondary endpoint was it in the subgroup.
RESULTS: Overall, 180 patients were assigned to the pre-compression group and the non-compression group (92 patients and 88 patients respectively) and 171 patients were analysed (88 patients in the pre-compression group and 83 patients in the non-compression group). Grade B/C pancreatic fistula was observed in 22 patients (12.9%), including 11 of 88 patients (12.5%) in the pre-compression group and 11 of 83 patients (13.3%) in the non-compression group (OR 0.94 (95% c.i. 0.38 to 2.31); P = 0.883).
CONCLUSION: A statistically significant difference in the incidence of grade B/C pancreatic fistula was not observed between the pre-compression group and the non-compression group.
REGISTRATION NUMBER: UMIN000042700 (https://www.umin.ac.jp).