Structure and Function of the Gastro-esophageal Junction
Combined Magnetic Resonance Imaging and High Resolution Manometry Studies
1 other identifier
interventional
24
1 country
1
Brief Summary
Aims of research project: To identify key features of the gastro-esophageal junction (structure and function) that protects the esophagus from gastro-esophageal reflux investigated by combined high resolution manometry and magnetic resonance imaging. Hypothesis:
- 1.Functional factors including GEJ function (e.g. sphincter pressure) and proximal gastric distension determine whether or not TLESR occurs; however
- 2.Structural factors including separation of GEJ anatomy, intra-gastric distribution of the meal and secretions determine whether TLESR is accompanied by no reflux event, gas reflux (belching) or reflux of ingested food and gastric secretion ('true reflux').
- 3.Initial findings by descriptive studies in healthy volunteers (study #1) and patients with mild to moderate gastro-esophageal reflux disease (study #2) will be further interrogated by a randomized, double-blind control trial of baclofen in patients with GORD; a medication that inhibits reflux by effects on GOJ function (study #3) .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2007
Longer than P75 for not_applicable
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
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 21, 2009
CompletedFirst Posted
Study publicly available on registry
January 21, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedJune 2, 2011
May 1, 2011
4.2 years
July 21, 2009
June 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gastro-oesophageal insertion angle, contact span (of stomach on oesophagus)
Gastro-oesophageal morphology from MRI imaging: insertion angle, contact span (of stomach on oesophagus) assessed from 3D models of stomach reconstructed from MRI imaging
Pre- and post-meal ingestion
Secondary Outcomes (3)
gastric emptying
post-meal
gastric accommodation
post-meal
number of reflux events
post-meal
Study Arms (2)
Baclofen
ACTIVE COMPARATORBaclofen suspension 40mg (single dose 90 minutes prior to physiologic measurement)
Placebo
PLACEBO COMPARATORPlacebo suspension (single dose 90 minutes prior to physiologic measurement)
Interventions
Eligibility Criteria
You may qualify if:
- Study #1:
- healthy male and female volunteers
- aged at least 18 and not more than 49 y
- no history of gastrointestinal symptoms
- able to communicate well with the investigators and to comply with the requirements for the entire study
- who provided written informed consent before participating in the study, after being given a full description of the trail.
- Study #2 and #3:
- male and female patients with mild to moderate gastro-oesophageal reflux disease defined by presence of (1) reflux symptoms (2) pathological esophageal acid exposure between 5-10% on 24 hour ambulatory testing
- aged at least 18 and not more than 49 y
- no history of gastrointestinal symptoms
- able to communicate well with the investigators and to comply with the requirements for the entire study
- who provided written informed consent before participating in the study, after being given a full description of the trail.
You may not qualify if:
- with present psychiatric disorders or mental impairment limiting the ability to comply with study requirements
- with use of medications influencing upper GI motility within one week of the study (i.e. beta- blocker, calcium channel blockers, nitrates, prokinetic drugs, macrolide antibiotics)
- with regular intake of medication; occasional use of analgesic e.g. aspirin, paracetamol is allowed
- with symptoms or a history of gastrointestinal disease other than gastro-esophageal reflux disease (in study #2 and #3)
- suffering from known liver, kidney, cardiovascular, neurological or pulmonary disease
- with any evidence of infectious disease
- with evidence or history of drug or alcohol abuse
- with insufficient knowledge of the German language • who, for any reason, are unable to complete the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Gastroenterology
Zurich, Canton of Zurich, CH-8091, Switzerland
Related Publications (1)
Curcic J, Roy S, Schwizer A, Kaufman E, Forras-Kaufman Z, Menne D, Hebbard GS, Treier R, Boesiger P, Steingoetter A, Fried M, Schwizer W, Pal A, Fox M. Abnormal structure and function of the esophagogastric junction and proximal stomach in gastroesophageal reflux disease. Am J Gastroenterol. 2014 May;109(5):658-67. doi: 10.1038/ajg.2014.25. Epub 2014 Mar 4.
PMID: 24589669DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
01 Studienregister MasterAdmins
UniversitaetsSpital Zuerich
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 21, 2009
First Posted
January 21, 2010
Study Start
February 1, 2007
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
June 2, 2011
Record last verified: 2011-05