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Prevention of Postoperative Pancreatic Fistula by Somatostatin

NCT03000946 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 655

Last updated 2025-09-11

No results posted yet for this study

Summary

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

Conditions

  • Pancreatic Surgery

Interventions

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

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Sébastien GAUJOUX, MD, PhD · La Pitié Salpêtrière Hospital, AP-HP

  • Bertrand DOUSSET, MD, PhD · Cochin Hospital, AP-HP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03000946 on ClinicalTrials.gov