Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy
Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy
Sponsors
Source
Universitair Ziekenhuis Brussel
Oversight Info
Has Dmc
Yes
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.
Overall Status
Unknown status
Start Date
2014-04-01
Completion Date
2016-04-01
Primary Completion Date
2015-12-01
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
Los Angeles criteria for reflux esophagitis |
4 weeks after the last injection with lanreotide |
Enrollment
10
Conditions
Intervention
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.
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
Kim Moubax, Assistent |
Study Chair |
University hospital of Brussels, Laarbeeklaan, Jette |
Overall Contact
Last Name
Kim Moubax, Assistent
Phone
003224749346
Phone Ext
0032476486103
Location
Facility |
Status |
Contact |
Investigator |
University Hospital of Brussels Jette 1090 Belgium |
Not yet recruiting |
Last Name: Kim Moubax, Assistent Phone: 003224749346 Phone Ext: 0032476486103 Email: [email protected]com/[email protected] |
Last Name: kim moubax, assistent Role: Principal Investigator |
Location Countries
Country
Belgium
Verification Date
2014-01-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Universitair Ziekenhuis Brussel
Investigator Full Name
Kim Moubax
Investigator Title
Dr. Kim Moubax, gastro-enterology
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Intervention Browse
Mesh Term
Lanreotide
Angiopeptin
Somatostatin
Arm Group
Arm Group Label
Lanreotide
Arm Group Type
Experimental
Description
Lanreotide autogel 120mg injection every 4 weeks (every patient will receive 3 injections)
Firstreceived Results Date
N/A
Overall Contact Backup
Reference
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.
PMID
16240061
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.
PMID
12239969
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.
PMID
17314604
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.
PMID
19095503
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. Review.
PMID
22430616
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.
PMID
10223779
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.
PMID
9056054
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. Review.
PMID
21964965
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
January 29, 2014
Study First Submitted Qc
January 31, 2014
Study First Posted
February 4, 2014
Last Update Submitted
January 31, 2014
Last Update Submitted Qc
January 31, 2014
Last Update Posted
February 4, 2014
Last Known Status
Not yet recruiting
ClinicalTrials.gov processed this data on December 10, 2019
Conditions
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conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.