PREFIPS: Prevention of Postoperative Pancreatic Fistula by Somatostatin

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT03000946

Collaborator

(none)

655

Enrollment

Locations

Arms

44.9

Actual Duration (Months)

327.5

Patients Per Site

7.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Surgery	Drug: Somatostatin Drug: Octreotide	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

655 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 15, 2017

Actual Primary Completion Date :

Feb 9, 2021

Actual Study Completion Date :

Feb 9, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

≥ grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification [90 days]

Secondary Outcome Measures

≥grade 3 pancreatic complication rates (fistula, leak, and abscess) [60 days]
as defined by the MSKCC surgical secondary events system
Overall pancreatic fistula rate (grade A,B and C) [90 days]
previous ISGPF classification
Overall pancreatic fistula rate (grade B and C) [90 days]
last ISGPF classification
Overall complication rate (grade 1 to 5) [90 days]
according to Clavien-Dindo classification
Severe complication rate (grade 3 to 5) [90 days]
according to Clavien-Dindo classification
Mortality (grade 5) [90 days]
according to Clavien-Dindo classification
Overall duration of drainage [90 days]
required in patients who develop pancreatic complications (date pancreatic complication identified - date drain removed)
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 [7 days after surgery]
only in patients undergoing pancreaticoduodenectomy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	La Pitié Salpêtrière Hospital	Paris		France	75013
2	Cochin Hospital	Paris		France	75014

Sponsors and Collaborators

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