Prevention of Postoperative Pancreatic Fistula by Somatostatin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

655 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2021-02-09

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pancreatic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Somatostatin

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

Group Type EXPERIMENTAL

Somatostatin

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Octreotide

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Octreotide

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

Intervention Type DRUG

Other Intervention Names

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Somatostatine Eumedica Siroctid

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No