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Prevention of Postoperative Pancreatic Fistula by Somatostatin (PREFIPS)

Primary Purpose

Pancreatic Surgery

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Somatostatin
Octreotide
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Surgery focused on measuring Pancreatectomy, Somatostatin analogue, Octreotide, Pancreatic fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • La Pitié Salpêtrière Hospital
  • Cochin Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Somatostatin

Octreotide

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 20, 2016
Last Updated
April 30, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03000946
Brief Title
Prevention of Postoperative Pancreatic Fistula by Somatostatin
Acronym
PREFIPS
Official Title
Prevention of Postoperative Pancreatic Fistula by SOMATOSTATIN Compared to OCTREOTIDE: Prospective, Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
February 9, 2021 (Actual)
Study Completion Date
February 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Surgery
Keywords
Pancreatectomy, Somatostatin analogue, Octreotide, Pancreatic fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
655 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Somatostatin
Arm Type
Experimental
Arm Description
Continuous intravenous infusion of somatostatin-14, 6 mg per day during 6.5 days
Arm Title
Octreotide
Arm Type
Active Comparator
Arm Description
Subcutaneous octreotide 100 μg 3 times a day for 6.5 days.
Intervention Type
Drug
Intervention Name(s)
Somatostatin
Other Intervention Name(s)
Somatostatine Eumedica
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Octreotide
Other Intervention Name(s)
Siroctid
Intervention Description
Solution for Subcutaneous use 100μg, every 8 hours Subcutaneous injection for 6,5 days
Primary Outcome Measure Information:
Title
≥ grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification
Time Frame
90 days
Secondary Outcome Measure Information:
Title
≥grade 3 pancreatic complication rates (fistula, leak, and abscess)
Description
as defined by the MSKCC surgical secondary events system
Time Frame
60 days
Title
Overall pancreatic fistula rate (grade A,B and C)
Description
previous ISGPF classification
Time Frame
90 days
Title
Overall pancreatic fistula rate (grade B and C)
Description
last ISGPF classification
Time Frame
90 days
Title
Overall complication rate (grade 1 to 5)
Description
according to Clavien-Dindo classification
Time Frame
90 days
Title
Severe complication rate (grade 3 to 5)
Description
according to Clavien-Dindo classification
Time Frame
90 days
Title
Mortality (grade 5)
Description
according to Clavien-Dindo classification
Time Frame
90 days
Title
Overall duration of drainage
Description
required in patients who develop pancreatic complications (date pancreatic complication identified - date drain removed)
Time Frame
90 days
Title
Overall length of stay
Time Frame
90 days
Title
Re-admission rate
Time Frame
90 days
Title
Cost effectiveness
Time Frame
90 days
Title
Fistula according to possible new definition of the ISGPF group
Time Frame
90 days
Title
Postoperative quality of life after pancreatic surgery
Description
only in patients undergoing pancreaticoduodenectomy
Time Frame
7 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien GAUJOUX, MD, PhD
Organizational Affiliation
La Pitié Salpêtrière Hospital, AP-HP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bertrand DOUSSET, MD, PhD
Organizational Affiliation
Cochin Hospital, AP-HP
Official's Role
Study Chair
Facility Information:
Facility Name
La Pitié Salpêtrière Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Prevention of Postoperative Pancreatic Fistula by Somatostatin

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