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

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

Study Overview

• Status: Terminated
• Conditions: High Output Stoma
• Intervention / Treatment: Drug: Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide); Drug: Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • Hôpital Jean Minjoz - Service de Chirurgie Digestive
  • Colmar, France, 68024
    • Hôpitaux Civils de Colmar - Service de Chirurgie Digestive
  • Dijon, France
    • Hopital du Bocage - CHU Dijon- Service de Chirurgie Digestive
  • Mulhouse, France, 68070
    • Hôpital Emile MULLER - Service de Chirurgie Digestive
  • Reims, France, 51100
    • CHU Robert Debré Service de chirurgie générale, digestive et endocrinienne
  • Strasbourg, France, 67098
    • Hôpital de Hautepierre-Service de Chirurgie Digestive

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lanreotide and anti-diarrheal treatments; 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	Drug: Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide)
Active Comparator: Current anti-diarrheal treatments 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	Drug: Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of ileostomy bags used per day	72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Collaborators: Ipsen
• Investigators: Principal Investigator: Benoit ROMAIN, MD, Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2015
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): January 26, 2018

Study Registration Dates

• First Submitted: January 26, 2015
• First Submitted That Met QC Criteria: January 29, 2015
• First Posted (Estimate): February 3, 2015

Study Record Updates

• Last Update Posted (Actual): March 7, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Gastrointestinal Agents; Lanreotide; Loperamide; Antidiarrheals
• Other Study ID Numbers: 5971

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No