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

Universitair Ziekenhuis Brussel

Status and phase: Unknown; Phase 2

Conditions: Non-acid Reflux Esophagitis; Acid Reflux Esophagitis

Treatments: Drug: Lanreotide

Study type: Interventional

Funder types: Other

Identifiers

NCT02054637

PHV106-B.05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Lanreotide

Experimental group

Description:

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

Treatment:

Drug: Lanreotide