Clinical trial NCT02354768: Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study
Official title: Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: High Output Stoma
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: Ipsen
First posted: 2015-02-03
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of ileostomy bags used per day
timeFrame: 72 hours
Secondary outcomes:
measure: Number of ileostomy bags used per day
timeFrame: from Day 0 to Day 6
measure: Blood urea and creatinine rates
timeFrame: every 2 days until Day6 (Day 0, Day 2, Day 4, Day 6)
measure: Length of stay
timeFrame: duration of hospital stay, an expected average of 6 days
measure: Serious adverse events
timeFrame: Day 0, Day 1 Day 2, Day3, Day 4, Day 5, Day 6, 1 month
Other outcomes:
Locations:
city: Besançon
country: France
facility: Hôpital Jean Minjoz - Service de Chirurgie Digestive
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar - Service de Chirurgie Digestive
city: Dijon
country: France
facility: Hopital du Bocage - CHU Dijon- Service de Chirurgie Digestive
city: Mulhouse
country: France
facility: Hôpital Emile MULLER - Service de Chirurgie Digestive
city: Reims
country: France
facility: CHU Robert Debré Service de chirurgie générale, digestive et endocrinienne
city: Strasbourg
country: France
facility: Hôpital de Hautepierre-Service de Chirurgie Digestive
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Benoit ROMAIN, MD
role: PRINCIPAL_INVESTIGATOR
References: