• PARANOIA Study Group:, Writing group:, James M Halle-Smith, Rupaly Pande, Lewis Hall, James Hodson, Keith J Roberts, Steering committee:, Ali Arshad, Saxon Connor, Kevin C P Conlon, Euan J Dickson, Francesco Giovinazzo, Ewen Harrison, Nicola de Liguori Carino, Todd Hore, Stephen R Knight, Benjamin Loveday, Laura Magill, Darius Mirza, Anubhav Mitta, Sanjay Pandanaboyana, Rita J Perry, Thomas Pinkney, Jas Samra, Ajith K Siriwardena, Sohei Satoi, James Skipworth, Stefan Stättner, Robert P Sutcliffe, and Bobby Tingstedt.
• Hepatobiliary and Pancreatic Surgery Unit, Queen Elizabeth Hospital, Birmingham, UK.
• Br J Surg. 2022 Aug 16; 109 (9): 812-821.

BackgroundData on interventions to reduce postoperative pancreatic fistula (POPF) following pancreatoduodenectomy (PD) are conflicting. The aim of this study was to assimilate data from RCTs.MethodsMEDLINE and Embase databases were searched systematically for RCTs evaluating interventions to reduce all grades of POPF or clinically relevant (CR) POPF after PD. Meta-analysis was undertaken for interventions investigated in multiple studies. A post hoc analysis of negative RCTs assessed whether these had appropriate statistical power.ResultsAmong 22 interventions (7512 patients, 55 studies), 12 were assessed by multiple studies, and subjected to meta-analysis. Of these, external pancreatic duct drainage was the only intervention associated with reduced rates of both CR-POPF (odds ratio (OR) 0.40, 95 per cent c.i. 0.20 to 0.80) and all-POPF (OR 0.42, 0.25 to 0.70). Ulinastatin was associated with reduced rates of CR-POPF (OR 0.24, 0.06 to 0.93). Invagination (versus duct-to-mucosa) pancreatojejunostomy was associated with reduced rates of all-POPF (OR 0.60, 0.40 to 0.90). Most negative RCTs were found to be underpowered, with post hoc power calculations indicating that interventions would need to reduce the POPF rate to 1 per cent or less in order to achieve 80 per cent power in 16 of 34 (all-POPF) and 19 of 25 (CR-POPF) studies respectively.ConclusionThis meta-analysis supports a role for several interventions to reduce POPF after PD. RCTs in this field were often relatively small and underpowered, especially those evaluating CR-POPF.© The Author(s) 2022. Published by Oxford University Press on behalf of BJS Society Ltd. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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