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

• Status: Unknown status
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universitair Ziekenhuis Brussel
• Treatments: Angiopeptin; Lanreotide; Somatostatin

Criteria

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.