Current partner codePEPTIDESDE
NCT03000946·Phase 3·INTERVENTIONAL

Prevention of Postoperative Pancreatic Fistula by Somatostatin

Status

Completed

Phase

Phase 3

Enrollment

655

Locations

2

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

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

DRUG

Octreotide

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

Timeline

From registration to results.

  1. First posted

    Dec 22, 2016

  2. Study start

    May 15, 2017

  3. Primary completion

    Feb 9, 2021

  4. Study completion

    Feb 9, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Sep 11, 2025

Outcomes

What the study measures.

Primary outcomes

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

Time frame · 90 days

Secondary outcomes

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

Time frame · 60 days

as defined by the MSKCC surgical secondary events system

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

Time frame · 90 days

previous ISGPF classification

Overall pancreatic fistula rate (grade B and C)

Time frame · 90 days

last ISGPF classification

Overall complication rate (grade 1 to 5)

Time frame · 90 days

according to Clavien-Dindo classification

Severe complication rate (grade 3 to 5)

Time frame · 90 days

according to Clavien-Dindo classification

Mortality (grade 5)

Time frame · 90 days

according to Clavien-Dindo classification

Overall duration of drainage

Time frame · 90 days

required in patients who develop pancreatic complications (date pancreatic complication identified - date drain removed)

Overall length of stay

Time frame · 90 days

Re-admission rate

Time frame · 90 days

Cost effectiveness

Time frame · 90 days

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

2 registered sites.

France. Showing up to 24 locations stored in the fast local snapshot.

Cochin Hospital

Paris, Paris, France

La Pitié Salpêtrière Hospital

Paris, France

Related trials

More studies on Octreotide.

Related PeptideStat pages

Put the record in context.

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