Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2014
CompletedFirst Posted
Study publicly available on registry
February 4, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFebruary 4, 2014
January 1, 2014
1.7 years
January 29, 2014
January 31, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Lanreotide
EXPERIMENTALLanreotide autogel 120mg injection every 4 weeks (every patient will receive 3 injections)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Pregnancy or inadequate anticonception, breast feeding.
- Negative impedancemetry.
- Diabetes.
- Placement of a gastric ring for weight loss.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Brussels
Jette, 1090, Belgium
Related Publications (8)
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.
PMID: 16240061BACKGROUNDMontesani 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: 12239969BACKGROUNDGerard 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.
PMID: 17314604BACKGROUNDSwartz 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: 19095503BACKGROUNDGans 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.
PMID: 22430616BACKGROUNDDrewe 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.
PMID: 10223779BACKGROUNDLamrani 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.
PMID: 9056054BACKGROUNDLudlam 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.
PMID: 21964965BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kim Moubax, Assistent
University hospital of Brussels, Laarbeeklaan, Jette
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Kim Moubax, gastro-enterology
Study Record Dates
First Submitted
January 29, 2014
First Posted
February 4, 2014
Study Start
April 1, 2014
Primary Completion
December 1, 2015
Study Completion
April 1, 2016
Last Updated
February 4, 2014
Record last verified: 2014-01