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

Sponsor

Universitair Ziekenhuis Brussel (Other)

Overall Status

Unknown status

CT.gov ID

NCT02054637

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acid Reflux Esophagitis Non-acid Reflux Esophagitis	Drug: Lanreotide	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lanreotide Lanreotide autogel 120mg injection every 4 weeks (every patient will receive 3 injections)	Drug: Lanreotide Other Names: Somatuline

Arm

Intervention/Treatment

Experimental: Lanreotide

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

Drug: Lanreotide

Other Names:

Somatuline

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.