NCT03000946

Prevention of Postoperative Pancreatic Fistula by Somatostatin

Prevention of Postoperative Pancreatic Fistula by SOMATOSTATIN Compared to OCTREOTIDE: Prospective, Randomized, Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 655 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Prevention of pancreatic fistula remains a major challenge for surgeons, and various technical and pharmacological intervention have been investigated, with conflicting results. Despite several prospective studies, and metaanalyses, the prophylactic role on pancreatic fistula of octreotide, remains controversial, even if recommended for routine use in patients undergoing pancreatic resection. In view of recent result, the investigators can hypothesize that higher affinity for somatostatin-receptor lead to stronger pancreatic exocrine secretion inhibition, and better pancreatic fistula prevention. Consequently, continuous intravenous infusion of somatostatin-14, the natural peptide hormone, associated with 10 to 50 time stronger affinity with all somatostatin receptor, will be associated with a improved pancreatic fistula prevention compared to octreotide.

Conditions

• Pancreatic Surgery

Interventions

Type	Name	Description
DRUG	Somatostatin	Lyophilisate and solution for IV use (glass ampoule of lyophilisate + 1 ml glass ampoule of solvent) 6 mg per day Continuous intravenous infusion for 6,5 days
DRUG	Octreotide	Solution for Subcutaneous use 100μg, every 8 hours Subcutaneous injection for 6,5 days

Timeline

• Start date: 2017-05-15
• Primary completion: 2021-02-09
• Completion: 2021-02-09
• First posted: 2016-12-22
• Last updated: 2025-09-11

Locations

2 sites across 1 country: France