Prevention of Postoperative Pancreatic Fistula by Somatostatin (PREFIPS)

September 5, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

655

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • La Pitié Salpêtrière Hospital
    • Paris
      • Paris, Paris, France, 75014
        • Cochin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men or women aged 18 years or greater
  • Signed informed consent
  • Candidate for pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy

Exclusion Criteria:

  • Patient with radiation therapy
  • Patient with neoadjuvant chemotherapy within 4 weeks before surgery
  • Pregnancy
  • Breastfeeding
  • Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator
  • Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to inclusion
  • Known hypersensitivity to somatostatin or somatostatin analogues or any component of the somatostatin or octreotide long-acting release (LAR) or s.c. formulations
  • Patient previously treated with somatostatin or somatostatin analogues or any component of the somatostatin or octreotide LAR or s.c. formulations
  • Patients treated by ciclosporin
  • Patient without health insurance or social security
  • Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Somatostatin
Continuous intravenous infusion of somatostatin-14, 6 mg per day during 6.5 days
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
Other Names:
  • Somatostatine Eumedica
Active Comparator: Octreotide
Subcutaneous octreotide 100 μg 3 times a day for 6.5 days.
Drug: Octreotide
Solution for Subcutaneous use 100μg, every 8 hours Subcutaneous injection for 6,5 days
Other Names:
  • Siroctid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
≥ grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
≥grade 3 pancreatic complication rates (fistula, leak, and abscess)
Time Frame: 60 days
as defined by the MSKCC surgical secondary events system
60 days
Overall pancreatic fistula rate (grade A,B and C)
Time Frame: 90 days
previous ISGPF classification
90 days
Overall pancreatic fistula rate (grade B and C)
Time Frame: 90 days
last ISGPF classification
90 days
Overall complication rate (grade 1 to 5)
Time Frame: 90 days
according to Clavien-Dindo classification
90 days
Severe complication rate (grade 3 to 5)
Time Frame: 90 days
according to Clavien-Dindo classification
90 days
Mortality (grade 5)
Time Frame: 90 days
according to Clavien-Dindo classification
90 days
Overall duration of drainage
Time Frame: 90 days
required in patients who develop pancreatic complications (date pancreatic complication identified - date drain removed)
90 days
Overall length of stay
Time Frame: 90 days
90 days
Re-admission rate
Time Frame: 90 days
90 days
Cost effectiveness
Time Frame: 90 days
90 days
Fistula according to possible new definition of the ISGPF group
Time Frame: 90 days
90 days
Postoperative quality of life after pancreatic surgery
Time Frame: 7 days after surgery
only in patients undergoing pancreaticoduodenectomy
7 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Unité de Recherche Clinique Necker Cochin, France

Investigators

  • Principal Investigator: Sébastien GAUJOUX, MD, PhD, La Pitié Salpêtrière Hospital, AP-HP
  • Study Chair: Bertrand DOUSSET, MD, PhD, Cochin Hospital, AP-HP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2017

Primary Completion (Actual)

February 9, 2021

Study Completion (Actual)

February 9, 2021

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 20, 2016

First Posted (Estimated)

December 22, 2016

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P150915
  • 2016-001673-32 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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