Prevention of Postoperative Pancreatic Fistula by Somatostatin

Pancreatic Surgery Clinical Trial

— PREFIPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03000946
• Other study ID #: P150915
• Secondary ID: 2016-001673-32
• Status: Completed
• Phase: Phase 3
• Start date: May 15, 2017
• Est. completion date: February 9, 2021

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 655
• Est. completion date: February 9, 2021
• Est. primary completion date: February 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula
• Pancreatic Surgery

Intervention

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

Locations

Country	Name	City	State
France	Cochin Hospital	Paris
France	La Pitié Salpêtrière Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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