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NCT02354768: ILEHOS

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

Terminated Phase 3 Last updated 7 March 2018
What this trial tests

Phase 3 trial testing Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide) in High Output Stoma in 19 participants. Terminated before completion.

Timeline
22 October 2015
Primary endpoint
31 December 2017
26 January 2018

Quick facts

Lead sponsorUniversity Hospital, Strasbourg, France
PhasePhase 3
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment19
Start date22 October 2015
Primary completion31 December 2017
Estimated completion26 January 2018
Sites6 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Strasbourg, France

Who can join

18 and older, any sex, with High Output Stoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Lanreotide in the prevention and management of high-output ileostomy after colorectal cancer surgery.
    Cuyle PJ, Engelen A, Moons V, Tollens T, et al · · 2018 · cited 3× · PMID 29888099 · DOI 10.1080/21556660.2018.1467916

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