Somatostatin Versus Octreotide for Prevention of Postoperative Pancreatic Fistula: The PREFIPS Randomized Clinical Trial: A FRENCH 007-ACHBT Study.

Autor:	Gaujoux S; Department of Hepatobiliary and Pancreatic Surgery and Liver Transplantation, AP-HP Pitié-Salpêtrière Hospital, Paris, France.; Sorbonne University, Paris, France., Regimbeau JM; Department of Oncology and Digestive Surgery, CHU Amiens-Picardie, Amiens, France.; University of Picardie Jules-Vernes, Amiens, France., Piessen G; Department of Digestive and Oncological Surgery, CHU Lille, Lille, France.; University Lille, CNRS, Inserm, CHU Lille, UMR9020-U1277-CANTHER-Cancer Heterogeneity Plasticity and Resistance to Therapies, Lille, France., Truant S; University Lille, CNRS, Inserm, CHU Lille, UMR9020-U1277-CANTHER-Cancer Heterogeneity Plasticity and Resistance to Therapies, Lille, France.; Department of Digestive Surgery and Transplantation, CHU Lille, Lille, France., Foissac F; Clinical Research Unit Necker Cochin Hospital, APHP, Paris, France., Barbier L; Department of Digestive Surgery and Liver Transplantation, CHU Tours Trousseau, Tours, France.; University of Tours, Tours, France., Buc E; Department of Digestive and Hepatobiliary Surgery, Estaing Hospital, CHU Clermont-Ferrand, Clermont-Ferrand, France.; Clermont-Ferrand Faculty of Medicine, Clermont-Ferrand, France., Adham M; Digestive Surgery Unit, Edouard Herriot Hospital, Lyon, France.; Hospices Civils of Lyon University, Lyon, France., Fuks D; Department of Digestive, Pancreatic, Hepatobiliary and Endocrine Surgery, Cochin Hospital, APHP, Paris, France.; University of Paris, Paris, France., Deguelte S; Digestive Surgery Department, Reims University Hospital, Robert Debré Hospital, Reims, France.; Reims University Hospital, Robert Debré Hospital, Reims, France., Muscari F; Digestive Surgery and Liver Transplantation Department, Toulouse University Hospital, Toulouse, France.; Toulouse University, Toulouse, France., Sulpice L; Department of Hepatobiliary and Digestive Surgery Hospital Rennes, Rennes, France.; Rennes University, Rennes, France., Vaillant JC; Department of Hepatobiliary and Pancreatic Surgery and Liver Transplantation, AP-HP Pitié-Salpêtrière Hospital, Paris, France.; Sorbonne University, Paris, France., Schwarz L; Department of Digestive Surgery, Charles Nicolle Hospital, Rouen, France.; Rouen University, Rouen, France., Sa Cunha A; Department of Hepatobiliary Surgery and Liver Transplantation, Paul Brousse Hospital, Villejuif, France.; Paris-Saclay University, Saclay, France., Muzzolini M; Department of Hepatobiliary and Pancreatic Surgery and Liver Transplantation, AP-HP Pitié-Salpêtrière Hospital, Paris, France.; Sorbonne University, Paris, France., Dousset B; Department of Digestive, Pancreatic, Hepatobiliary and Endocrine Surgery, Cochin Hospital, APHP, Paris, France.; University of Paris, Paris, France., Sauvanet A; Department of Hepatobiliary Surgery, Beaujon Hospital, Clichy, France.; University Paris Cité, Paris, France.
Jazyk:	angličtina
Zdroj:	Annals of surgery [Ann Surg] 2024 Aug 01; Vol. 280 (2), pp. 179-187. Date of Electronic Publication: 2024 Apr 25.
DOI:	10.1097/SLA.0000000000006313
Abstrakt:	Objective: Pharmacological 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. Methods: Multicentric 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. Results: Of 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. Conclusion: Continuous intravenous somatostatin is not statistically different from subcutaneous octreotide in the prevention of grade B/C POPF after pancreatectomy. Findings: In 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. Competing Interests: S.G. reported grants, personal fees, and nonfinancial support fomr IPSEN, Mylan, Mayoli, Novartis. The remaining authors report no conflicts of interest. (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu