Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study
ILEHOS
1 other identifier
interventional
19
1 country
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2015
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2015
CompletedFirst Posted
Study publicly available on registry
February 3, 2015
CompletedStudy Start
First participant enrolled
October 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2018
CompletedMarch 7, 2018
March 1, 2018
2.2 years
January 26, 2015
March 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of ileostomy bags used per day
72 hours
Secondary Outcomes (4)
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
Study Arms (2)
lanreotide and anti-diarrheal treatments
EXPERIMENTAL* 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
Current anti-diarrheal treatments alone
ACTIVE COMPARATOR* 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- people with guardianship or with judicial protection
- 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
- uncontrolled diabetis defined by HbA1c\> 7% at D0
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Strasbourg, Francelead
- Ipsencollaborator
Study Sites (6)
Hôpital Jean Minjoz - Service de Chirurgie Digestive
Besançon, 25030, France
Hôpitaux Civils de Colmar - Service de Chirurgie Digestive
Colmar, 68024, France
Hopital du Bocage - CHU Dijon- Service de Chirurgie Digestive
Dijon, France
Hôpital Emile MULLER - Service de Chirurgie Digestive
Mulhouse, 68070, France
CHU Robert Debré Service de chirurgie générale, digestive et endocrinienne
Reims, 51100, France
Hôpital de Hautepierre-Service de Chirurgie Digestive
Strasbourg, 67098, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benoit ROMAIN, MD
Hôpitaux Universitaires de Strasbourg
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2015
First Posted
February 3, 2015
Study Start
October 22, 2015
Primary Completion
December 31, 2017
Study Completion
January 26, 2018
Last Updated
March 7, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share