Prevention of Postoperative Pancreatic Fistula by Somatostatin

Phase 3 Completed 655 enrolled Assistance Publique - Hôpitaux de Paris URC-CIC Paris Descartes Necker Cochin · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether somatostatin is more effective that octreotide in the prevention of post-pancreatectomy pancreatic fistula

Timeline

Start: 2017-05-15
Primary completion: 2021-02-09
Completion: 2021-02-09

Outcome

Missed primary endpoint

paper 24.1%: somatostatin arm and 22.9%: octreotide arm (χ 2 test, P =0.73, ITT analysis). PMID 38662619 ↗

Publications

Results Gaujoux S, Regimbeau JM, Piessen G, Truant S, Foissac F, Barbier L, Buc E, Adham M, Fuks D, Deguelte S, Muscari F, Sulpice L, Vaillant JC, Schwarz L, Sa Cunha A, Muzzolini M, Dousset B, Sauvanet A; Collaborators. Somatostatin Versus Octreotide for Prevention of Postoperative Pancreatic Fistula: The PREFIPS Randomized Clinical Trial: A FRENCH 007-ACHBT Study. Ann Surg. 2024 Aug 1;280(2):179-187. doi: 10.1097/SLA.0000000000006313. Epub 2024 Apr 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Octreotide	Peptide	100 ug	—
Subject	Somatostatin	Traditional medicine (herbal / TCM)	6 mg	Intravenous