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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

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

NCT ID

NCT02054637

First Posted

January 29, 2014

Last Updated

January 31, 2014

Sponsor

Universitair Ziekenhuis Brussel

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

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

kimmoubax970@hotmail.com/kim.moubax@uzbrussel.be

First Name & Middle Initial & Last Name or Official Title & Degree

Daniël Urbain, Professor

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

kimmoubax970@hotmail.com/kim.moubax@uzbrussel.be

First Name & Middle Initial & Last Name & Degree

Daniël Urbain, Professor

daniel.urbain@uzbrussel.be

First Name & Middle Initial & Last Name & Degree

kim moubax, assistent

12. IPD Sharing Statement

Citations:

PubMed Identifier

16240061

Citation

Ishikawa M, Kitayama J, Kaizaki S, Nakayama H, Ishigami H, Fujii S, Suzuki H, Inoue T, Sako A, Asakage M, Yamashita H, Hatono K, Nagawa H. Prospective randomized trial comparing Billroth I and Roux-en-Y procedures after distal gastrectomy for gastric carcinoma. World J Surg. 2005 Nov;29(11):1415-20; discussion 1421. doi: 10.1007/s00268-005-7830-0.

Results Reference

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PubMed Identifier

12239969

Citation

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

17314604

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

19095503

Citation

Swartz DE, Mobley E, Felix EL. Bile reflux after Roux-en-Y gastric bypass: an unrecognized cause of postoperative pain. Surg Obes Relat Dis. 2009 Jan-Feb;5(1):27-30. doi: 10.1016/j.soard.2008.10.009. Epub 2008 Oct 30.

Results Reference

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PubMed Identifier

22430616

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.

Results Reference

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PubMed Identifier

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Citation

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.

Results Reference

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PubMed Identifier

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Citation

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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Citation

Ludlam WH, Anthony L. Safety review: dose optimization of somatostatin analogs in patients with acromegaly and neuroendocrine tumors. Adv Ther. 2011 Oct;28(10):825-41. doi: 10.1007/s12325-011-0062-9. Epub 2011 Sep 28.

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

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