Efficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive Fistulae

Phase 3

Completed

• Conditions: Digestive Fistulae
• Interventions: Drug: Lanreotide microparticles; Drug: Placebo

• Registration Number: NCT00729313
• Lead Sponsor: Ipsen

Brief Summary

The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the treatment of patients with digestive fistulae.

Detailed Description

The purpose of this study is to determine whether lanreotide 30mg compared to placebo is effective on the evolution of drainage volume of digestive fistulae in the 72 hours following the beginning of treatment and on the spontaneous closure time of digestive fistulae.

Study Timeline

• Study Start: 2000-04
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Study First Submitted: 2008-08-04
• Study First Submitted QC: 2008-08-06
• Study First Posted: 2008-08-07
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-01
• Last Update Posted: 2019-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

• Patient with pancreatic, duodenal, or small intestine fistula
• Patient with simple, externalised fistula
• Patient with fistula for which a medical conservative treatment is considered
• Patient with:
• for pancreatic fistulae: a mean drainage volume more than or equal to 100 ml/24h over 48 hours or more than or equal to 50 ml / 24h over 3 days and a concentration of amylase in the drainage fluid 3 times higher than in the serum over at least 2 or 3 consecutive days respectively,
• for duodenal and small intestine fistulae: a mean drainage volume more than or equal to 100ml/24h over 2 days

Exclusion Criteria

• Patient expected to require a surgical treatment of the fistula during the study
• Patient having uncontrolled intra-abdominal sepsis; Crohn's disease; radiotherapy lesions of the small bowel; a mesenteric vascular insufficiency; a fistula localised in cancer-infiltrated areas; a distal obstruction; an exposed fistula of the small intestine; or intra-abdominal foreign bodies.
• Patient receiving long-term corticotherapy
• Patient having received any somatostatin analogue as curative treatment of the fistula or any PRF somatostatin analogue within the previous month.
• Patient having previously undergone a transplant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lanreotide microparticles	Drug: Lanreotide 30 mg microparticle formulation One intra-muscular injection. A (maximum) 60 day "treatment" period (6 intra-muscular injections of lanreotide 30 mg microparticle formulation every 10 days): according to the patient's treatment response at 72h For non-responders patients lanreotide will be stopped.
2	Placebo	One intra-muscular injection. A (maximum) 60 day "treatment" period (6 intra-muscular injections of placebo every 10 days): according to the patient's treatment response at 72h. Non-responder patients having received placebo on the first injection should receive an open-labelled lanreotide treatment.

Primary Outcome Measures

Name	Time	Method
Number of patients with a reduction of fistula drainage volume > 50% of baseline at 72 hours.	Fistula drainage volume on 3rd day.

Secondary Outcome Measures

Name	Time	Method
Pancreatic or duodenal and small intestine fistula closing rate within D60	Day 60
Number of injections received by each patient	End of study
Percentage of fistula recurrence during the follow-up period	Duration of follow-up period for each patient is of 1 month
Percentage of mortality in each group	End of study
Closure time of digestive fistulae will be defined by the interval between D0 (day of the first injection) and the date of spontaneous closure of the fistula.	Day 60

Trial Locations

Locations (18)

Hôpital Nord; 🇫🇷 Marseille, France

CHU J. Minjoz; 🇫🇷 Besançon, France

Groupe Hospitalier Pitié-Salpêtrière; 🇫🇷 Paris, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, France

Hôpital A. Michallon; 🇫🇷 Grenoble, France

Hôpital Trousseau; 🇫🇷 Tours, France

CHU de Bicêtre; 🇫🇷 Kremlin Bicêtre, France

Hôpital de la Cavale Blanche; 🇫🇷 Brest, France

Hôpital Pontchaillou; 🇫🇷 Rennes, France

Hotel Dieu; 🇫🇷 Lyon, France

Hôpital Lariboisière; 🇫🇷 Paris, France

Hôpital de Brabois; 🇫🇷 Vandoeuvre les Nancy, France

Hôpital Avicenne; 🇫🇷 Bobigny, France

Hôpital Louis Mourier; 🇫🇷 Colombes, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

Hôpital de Hautepierre; 🇫🇷 Strasbourg, France

National Research Centre of Surgery; 🇷🇺 Moscow, Russian Federation

Institute of Surgery n.a. A.V. Vishnevsky; 🇷🇺 Moscow, Russian Federation