vMII for Measurement of Oesophageal Bolus Transport and Reflux - Full Text View

Purpose

Recent work at St. Thomas' has validated an innovative new design of a multichannel intraluminal impedance (MII) catheter that is sensitive to variation in oesophageal volume in healthy volunteers and patients. This project will establish the clinical value of volume sensitive MII (vMII) compared to conventional MII acquired simultaneously by the same catheter (ROC analysis). Studies will assess:

The accuracy of volume measurements and correlation between symptoms and the volume of bolus retention in patients with dysphagia.
The accuracy of volume measurements and correlation between symptoms and reflux volume in patients with reflux disease.

Follow up studies after appropriate treatment will assess whether symptomatic improvement is associated with a reduction in oesophageal volume retention/reflux.

The vMII technique will be applied with high resolution manometry (HRM). These investigations are complementary in that vMII assesses the success or failure of bolus transport (or occurrence of reflux) and HRM can assess:

the oesophageal dysfunction that results in bolus escape
the abnormal events at the gastro−oesophageal junction (reflux barrier) that allow reflux to occur.

with a reduction in oesophageal volume retention / reflux.

Condition	Intervention
Achalasia GORD	Procedure: Heller's Myotomy Procedure: Nissen Fundoplication Drug: domperidone or esomeprazole (Conservative management) Drug: Esomeprazole 40 mg

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Diagnostic
Official Title:	Volume Sensitive Multichannel Intraluminal Impedance (vMII) for the Measurement of Oesophageal Bolus Transport and Reflux

Resource links provided by NLM:

MedlinePlus related topics: Esophagus Disorders GERD Swallowing Disorders

Drug Information available for: Domperidone Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by Guy's and St Thomas' NHS Foundation Trust:

Primary Outcome Measures:

Does vMII provide an accurate assessment of volume in disease? [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Does vMII assessment of volume improve the accuracy with which 'events' are associated with symp? [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Does symp improvement post treatment correlate with reduced 'volume events'?. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	140
Study Start Date:	November 2007
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Achalasia Long vs Short Myotomy repair of Achalasia	Procedure: Heller's Myotomy Long vs Short Heller's Myotomy for Achalasia
Experimental: Dysphagia control Conservative Management	Drug: domperidone or esomeprazole (Conservative management) Conservative management for dysphagia not referred for surgery. Conservative management: balloon dilatation or drugs such as domperidone 10 mg or esomeprazole 40 mg
Experimental: GORD for surgery Partial vs Full Fundoplication repair	Procedure: Nissen Fundoplication Partial vs Full Fundoplication for GORD
Experimental: GORD not for surgery esomeprazole 40 mg vs no esomeprazole	Drug: Esomeprazole 40 mg Esomeprazole vs no esomeprazole for GORD not referred for surgery

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

male or female
at least 18 years of age
have given informed consent for the vMII and Barium videofluoroscopy
have symptoms of reflux, dysphagia, have known achalasia or are planned for anti-reflux surgery

Exclusion Criteria:

with medications influencing gastrointestinal function within 3 days of the study
with those on anticoagulants
with any hematological abnormalities
with any evidence of infectious disease
who are pregnant or breast-feeding or sexually active and not on contraception.
with evidence or history of drug or alcohol abuse within the past two years
with diabetes mellitus
with severe physical or mental health concerns on screening which may contribute to the ability to comply with study requirements
with active co-morbid conditions
with oesophageal surgery or stent (dilation acceptable)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604942

Locations

United Kingdom
Oesophageal Laboratory, GSTT
London, United Kingdom, SE1 7EH

Sponsors and Collaborators

Guy's and St Thomas' NHS Foundation Trust

Investigators

Principal Investigator:

Mark Fox, MD

Honorary Consultant and Senior Lecturer

More Information

No publications provided

Responsible Party:	Dr Mark Fox, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:	NCT00604942 History of Changes
Other Study ID Numbers:	07/H0802/73
Study First Received:	January 15, 2008
Last Updated:	July 31, 2009
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:

Oesophagus
Dysphagia
Impedance
High Resolution Manometry

Peristalsis
Contractile Pressure
Coordination of contraction
Bolus transport

Additional relevant MeSH terms:

Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Domperidone
Omeprazole
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013