Prevention of Postoperative Pancreatic Fistula by Somatostatin (PREFIPS)

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: Pancreatic Surgery
• Intervention / Treatment: Drug: Somatostatin; Drug: Octreotide

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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

2

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	90 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Sébastien GAUJOUX, MD, PhD, La Pitié Salpêtrière Hospital, AP-HP; Study Chair: Bertrand DOUSSET, MD, PhD, Cochin hospital, AP-HP

Study record dates

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 (Estimate): December 22, 2016

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Pancreatectomy; Octreotide; Pancreatic fistula; Somatostatin analogue
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Fistula; Physiological Effects of Drugs; Antineoplastic Agents; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Octreotide; Somatostatin
• 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