NCT03000946

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
655

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2017

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

May 15, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2021

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

3.7 years

First QC Date

December 20, 2016

Last Update Submit

September 5, 2025

Conditions

Pancreatic Surgery

Keywords

PancreatectomySomatostatin analogueOctreotidePancreatic fistula

Outcome Measures

Primary Outcomes (1)

  • ≥ grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification

    90 days

Secondary Outcomes (12)

  • ≥grade 3 pancreatic complication rates (fistula, leak, and abscess)

    60 days

  • Overall pancreatic fistula rate (grade A,B and C)

    90 days

  • Overall pancreatic fistula rate (grade B and C)

    90 days

  • Overall complication rate (grade 1 to 5)

    90 days

  • Severe complication rate (grade 3 to 5)

    90 days

  • +7 more secondary outcomes

Study Arms (2)

Somatostatin

EXPERIMENTAL

Continuous intravenous infusion of somatostatin-14, 6 mg per day during 6.5 days

Drug: Somatostatin

Octreotide

ACTIVE COMPARATOR

Subcutaneous octreotide 100 μg 3 times a day for 6.5 days.

Drug: Octreotide

Interventions

SomatostatinDRUG

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

Also known as: Somatostatine Eumedica
Somatostatin
OctreotideDRUG

Solution for Subcutaneous use 100μg, every 8 hours Subcutaneous injection for 6,5 days

Also known as: Siroctid
Octreotide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cochin Hospital

Paris, Paris, 75014, France

Location

La Pitié Salpêtrière Hospital

Paris, 75013, France

Location

Related Publications (1)

  • 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.

    PMID: 38662619BACKGROUND

MeSH Terms

Conditions

Pancreatic Fistula

Interventions

SomatostatinOctreotide

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPancreatic HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteinsPeptides, CyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Sébastien GAUJOUX, MD, PhD

    La Pitié Salpêtrière Hospital, AP-HP

    PRINCIPAL INVESTIGATOR

  • Bertrand DOUSSET, MD, PhD

    Cochin Hospital, AP-HP

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2016

First Posted

December 22, 2016

Study Start

May 15, 2017

Primary Completion

February 9, 2021

Study Completion

February 9, 2021

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)