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

Abstract

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).