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

Phase 2

• Conditions: Acid Reflux Esophagitis; Non-acid Reflux Esophagitis
• Interventions: Drug: Lanreotide

• Registration Number: NCT02054637
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

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

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.

Study Timeline

• Status Verified: 2014-01
• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-01-31
• Last Update Submitted: 2014-01-31
• Study First Posted: 2014-02-04
• Last Update Posted: 2014-02-04
• Study Start: 2014-04
• Primary Completion: 2015-12
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lanreotide	Lanreotide	Lanreotide autogel 120mg injection every 4 weeks (every patient will receive 3 injections)

Primary Outcome Measures

Name	Time	Method
Los Angeles criteria for reflux esophagitis	4 weeks after the last injection with lanreotide	Endoscopy at the start of the study will be compared with endoscopy at the end of the study.

Trial Locations

Locations (1)

University Hospital of Brussels; 🇧🇪 Jette, Belgium