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

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

Detailed Description
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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.

Official Title
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A Phase III Multicentre Randomised Double-blind Comparative Study of Efficacy and Safety of Lanreotide 30 mg Versus Placebo for Treatment of Patients With Digestive Fistulae

Conditions
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Digestive Fistulae

Intervention / Treatment
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* Drug: Lanreotide microparticles
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Drug: Lanreotide microparticles<br> <br> |
| Placebo Comparator: 2<br>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. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment