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.
| Status | Not yet recruiting |
| Enrollment | 10 |
| Est. completion date | April 2016 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital of Brussels | Jette |
| Lead Sponsor | Collaborator |
|---|---|
| Universitair Ziekenhuis Brussel |
Belgium,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Los Angeles criteria for reflux esophagitis | Endoscopy at the start of the study will be compared with endoscopy at the end of the study. | 4 weeks after the last injection with lanreotide | No |