Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study

Phase 3

Terminated

• Conditions: High Output Stoma
• Interventions: Drug: Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone; Drug: Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide)

• Registration Number: NCT02354768
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

Dehydration is a major problem of high output stoma with a 17% rate of readmission at 30 days. Dehydratations are resulting of significant electrolyte loss: sodium, potassium and renal failure. Nowadays, there are no recommendations nor national nor international for high output ileostomy treatment. Apart from the anti-diarrhea treatments used in current practice, somatostatin analogs have proven efficacy in the literature. Theses analogs permit to decrease significantly gastrointestinal secretions. Several teams use these analogs in order to decrease the flow of highly productive ileostomy.

The aim of the study is to evaluate the efficacy first line treatment with lanreotide associated with current anti-diarrheal treatment for patients with high output ileostomy (or greater throughput 1.5l / 24h) with or without associated dehydration

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-02-03
• Study Start: 2015-10-22
• Primary Completion: 2017-12-31
• Study Completion: 2018-01-26
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Legal at the time of signing the agreement
• Subject affiliated to the french social protection
• Ileostomy has achieved since 10 days minimum at day 0 (D0: start of study treatment)
• Ileostomy output > 1.5 liters / 24h for at least 24 hours at day 0
• accept to use an effective method of contraception during the study: (during the 6 months following injection of lanreotide for the experimental group and for the control group: 4 days after the last dose of chlorhydrate of loperamide
• People able to understand the objectives, modalities and risks related to the study and give written informed consent

Exclusion Criteria

• people with guardianship or with judicial protection
• simultaneous participation in another biomedical research protocol involving a drug or topic exclusion period
• pregnancy or breastfeeding
• administration of lanreotide or related peptide between surgery and D0
• hypersensitivities to lanreotide or related peptides and / or diosmectite and / or loperamide and / or one of their excipients
• acute hemorrhagic colitis
• bloody diarrhea and / or high fever
• Clostridium Difficile Infection at the inclusion
• uncontrolled diabetis defined by HbA1c> 7% at D0

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Current anti-diarrheal treatments alone	Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone	* Diosmectite (3 g) 6 / day for 72 hours (fromD0 to D3) * Chlorhydrate of Loperamide (2 mg capsule or tablet) 6 / day for 72 hours (D0 to D3) * Hydration
lanreotide and anti-diarrheal treatments	Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide)	* Lanreotide: 1 single injection at day 0 (lanreotide 120 mg) * Diosmectite (3 g) 6 / day for 72 hours (fromD0 to D3) * Chlorhydrate of Loperamide (2 mg capsule or tablet) 6 / day for 72 hours (D0 to D3) * hydration

Primary Outcome Measures

Name	Time	Method
Number of ileostomy bags used per day	72 hours

Secondary Outcome Measures

Name	Time	Method
Number of ileostomy bags used per day	from Day 0 to Day 6
Blood urea and creatinine rates	every 2 days until Day6 (Day 0, Day 2, Day 4, Day 6)
Length of stay	duration of hospital stay, an expected average of 6 days
Serious adverse events	Day 0, Day 1 Day 2, Day3, Day 4, Day 5, Day 6, 1 month

Trial Locations

Locations (6)

Hôpital Jean Minjoz - Service de Chirurgie Digestive; 🇫🇷 Besançon, France

Hôpital Emile MULLER - Service de Chirurgie Digestive; 🇫🇷 Mulhouse, France

Hôpitaux Civils de Colmar - Service de Chirurgie Digestive; 🇫🇷 Colmar, France

Hopital du Bocage - CHU Dijon- Service de Chirurgie Digestive; 🇫🇷 Dijon, France

CHU Robert Debré Service de chirurgie générale, digestive et endocrinienne; 🇫🇷 Reims, France

Hôpital de Hautepierre-Service de Chirurgie Digestive; 🇫🇷 Strasbourg, France