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

Primary Purpose

Acid Reflux Esophagitis, Non-acid Reflux Esophagitis

Status
Unknown status
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Lanreotide
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acid Reflux Esophagitis focused on measuring Bile reflux, Reflux esophagitis, Lanreotide autogel, Somatuline, Endoscopy, Impedancemetry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • University Hospital of Brussels

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lanreotide

Arm Description

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

Outcomes

Primary Outcome Measures

Los Angeles criteria for reflux esophagitis
Endoscopy at the start of the study will be compared with endoscopy at the end of the study.

Secondary Outcome Measures

Full Information

First Posted
January 29, 2014
Last Updated
January 31, 2014
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT02054637
Brief Title
Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy
Official Title
Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acid Reflux Esophagitis, Non-acid Reflux Esophagitis
Keywords
Bile reflux, Reflux esophagitis, Lanreotide autogel, Somatuline, Endoscopy, Impedancemetry

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lanreotide
Arm Type
Experimental
Arm Description
Lanreotide autogel 120mg injection every 4 weeks (every patient will receive 3 injections)
Intervention Type
Drug
Intervention Name(s)
Lanreotide
Other Intervention Name(s)
Somatuline
Primary Outcome Measure Information:
Title
Los Angeles criteria for reflux esophagitis
Description
Endoscopy at the start of the study will be compared with endoscopy at the end of the study.
Time Frame
4 weeks after the last injection with lanreotide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kim Moubax, Assistent
Phone
003224749346
Ext
0032476486103
Email
kimmoubax970@hotmail.com/kim.moubax@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Daniël Urbain, Professor
Email
daniel.urbain@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Moubax, Assistent
Organizational Affiliation
University hospital of Brussels, Laarbeeklaan, Jette
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of Brussels
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Moubax, Assistent
Phone
003224749346
Ext
0032476486103
Email
kimmoubax970@hotmail.com/kim.moubax@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Daniël Urbain, Professor
Email
daniel.urbain@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
kim moubax, assistent

12. IPD Sharing Statement

Citations:
PubMed Identifier
16240061
Citation
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Results Reference
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Montesani C, D'Amato A, Santella S, Pronio A, Giovannini C, Cristaldi M, Ribotta G. Billroth I versus Billroth II versus Roux-en-Y after subtotal gastrectomy. Prospective [correction of prespective] randomized study. Hepatogastroenterology. 2002 Sep-Oct;49(47):1469-73.
Results Reference
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PubMed Identifier
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Citation
Gerard PS, Gerczuk P, Finestone H. Bile reflux in the esophagus demonstrated by HIDA scintigraphy. Clin Nucl Med. 2007 Mar;32(3):224-5. doi: 10.1097/01.rlu.0000255039.24698.48. No abstract available.
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
Gans SL, van Westreenen HL, Kiewiet JJ, Rauws EA, Gouma DJ, Boermeester MA. Systematic review and meta-analysis of somatostatin analogues for the treatment of pancreatic fistula. Br J Surg. 2012 Jun;99(6):754-60. doi: 10.1002/bjs.8709. Epub 2012 Mar 20.
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Drewe J, Sieber CC, Mottet C, Wullschleger C, Larsen F, Beglinger C. Dose-dependent gastrointestinal effects of the somatostatin analog lanreotide in healthy volunteers. Clin Pharmacol Ther. 1999 Apr;65(4):413-9. doi: 10.1016/S0009-9236(99)70136-0.
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Lamrani A, Vidon N, Sogni P, Nepveux P, Catus F, Blumberg J, Chaussade S. Effects of lanreotide, a somatostatin analogue, on postprandial gastric functions and biliopancreatic secretions in humans. Br J Clin Pharmacol. 1997 Jan;43(1):65-70. doi: 10.1111/j.1365-2125.1997.tb00034.x.
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Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy

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