Acid Reflux Esophagitis Clinical Trial
Official title:
Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment