• Sébastien Gaujoux, Jean-Marc Regimbeau, Guillaume Piessen, Stéphanie Truant, Frantz Foissac, Louise Barbier, Emmanuel Buc, Mustapha Adham, David Fuks, Sophie Deguelte, Fabrice Muscari, Laurent Sulpice, Jean-Christophe Vaillant, Lilian Schwarz, Sa CunhaAntonioADepartment of Hepatobiliary Surgery and Liver Transplantation, Paul Brousse Hospital, Villejuif, France.Paris-Saclay University, Saclay, France., Milena Muzzolini, Bertrand Dousset, Alain Sauvanet, and Collaborators.
• Department of Hepatobiliary and Pancreatic Surgery and Liver Transplantation, AP-HP Pitié-Salpêtrière Hospital, Paris, France.
• Ann. Surg. 2024 Aug 1; 280 (2): 179187179-187.

ObjectivePharmacological prevention of postoperative pancreatic fistula (POPF) after pancreatectomy is open to debate. The present study compares clinically significant POPF rates in patients randomized between somatostatin versus octreotide as prophylactic treatment.MethodsMulticentric randomized controlled open study in patient's candidate for pancreaticoduodenectomy (PD) or distal pancreatectomy (DP) comparing somatostatin continuous intravenous infusion for 7 days versus octreotid 100 μg, every 8 hours subcutaneous injection for 7 days, stratified by procedure (PD vs DP) and size of the main pancreatic duct (>4 mm) on grade B/C POPF rates at 90 days based on an intention-to-treat analysis.ResultsOf 763 eligible patients, 651 were randomized: 327 in the octreotide arm and 324 in the somatostatin arm, with comparable the stratification criteria - type of surgery and main pancreatic duct dilatation. Most patients had PD (n=480; 73.8%), on soft/normal pancreas (n=367; 63.2%) with a nondilated main pancreatic duct (n=472; 72.5%), most often for pancreatic adenocarcinoma (n=311; 47.8%). Almost all patients had abdominal drainage (n=621; 96.1%) and 121 (19.5%) left the hospital with the drain in place (median length of stay=16 days). A total of 153 patients (23.5%) developed a grade B/C POPF with no difference between both groups: 24.1%: somatostatin arm and 22.9%: octreotide arm (χ 2 test, P =0.73, ITT analysis). Absence of statistically significant difference persisted after adjustment for stratification variables and in per-protocol analysis.ConclusionContinuous intravenous somatostatin is not statistically different from subcutaneous octreotide in the prevention of grade B/C POPF after pancreatectomy.FindingsIn the PREFIPS Randomized Clinical Trial including 651 patients, a total of 153 patients (23.5%) developed a grade B/C POPF with no significant difference between both groups: 24.1%: somatostatin arm and 22.9%: octreotide arm (χ 2 test, P =0.73, ITT analysis). Absence of statistically significant difference persisted after adjustment for stratification variables and in per-protocol analysis.Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.

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