Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy

Study Overview
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Brief Summary
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Somatostatine induces a dose-dependent reduction of postprandial plasma cholecystokinin (CCK) secretion with a concomitant inhibition of postprandial gallbladder contraction, abolishing almost completely bile salts output from the gallbladder. Somatostatine is also known to decrease acid production with significant increase of intragastric pH. In this way, somatostatine could influence acid as well as non-acid reflux by decreasing gallbladder emptying and decreasing acid secretion. Purpose of the study is to evaluate the efficacy of lanreotide autogel 120 mg on symptoms and endoscopic lesions in patients with an endoscopic gastrointestinal reflux esophagitis that cannot be controlled with classic therapy.

Detailed Description
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Patients presenting with persistent esophagitis on endoscopy while on proton pump inhibitors (PPI) treatment will receive a maximal therapy consisting of 2 x 40 mg of PPI before the meals (morning and evening) and a H2 blocker before bedtime (standard practice). They will be reevaluated endoscopically and clinically 2 months later (standard practice). If reflux persists, objectivized by impedancemetry (standard practice), they will be asked to participate in this study. Lanreotide autogel 120 mg deep subcutaneously every 4 weeks will be added to the treatment. A total of 3 injections per patient have been foreseen in this proof of concept study. Patients will be reevaluated clinically after 2, 4 and 8 weeks. At the end of the study a new upper gastrointestinal endoscopy and impedancemetry will be performed.

Official Title
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Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy

Conditions
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Acid Reflux Esophagitis, Non-acid Reflux Esophagitis

Intervention / Treatment
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* Drug: Lanreotide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persistent endoscopic reflux in spite of maximal medical therapy with PPI 2 x 40 mg (before breakfast and dinner) and 300 mg of H2 blocker ranitidine (at bedtime). The Los Angeles classification (LA) will be used to evaluate endoscopic reflux. Any distal esophageal ulcer with negative biopsy is also diagnostic for reflux. Persistent reflux is defined as: No reflux complaints but continuing endoscopic lesions and positive impedancemetry. Reflux complaints with continuing endoscopic lesions and positive impedancemetry. Reflux complaints without endoscopic lesions but positive impedancemetry. Exclusion Criteria: Pregnancy or inadequate anticonception, breast feeding. Negative impedancemetry. Diabetes. Placement of a gastric ring for weight loss.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lanreotide<br>Lanreotide autogel 120mg injection every 4 weeks (every patient will receive 3 injections) | Drug: Lanreotide<br> <br> * Other names: Somatuline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Los Angeles criteria for reflux esophagitis | Endoscopy at the start of the study will be compared with endoscopy at the end of the study. | 4 weeks after the last injection with lanreotide | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lanreotide autogel, Bile reflux, Reflux esophagitis, Somatuline, Endoscopy, Impedancemetry