Volume Sensitive Multichannel Intraluminal Impedance (vMII) for the Measurement of Oesophageal Bolus Transport and Reflux
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Does vMII provide an accurate assessment of volume in disease?
Study Overview
Brief Summary
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.
Detailed Description
Swallowing problems and gastro-oesophageal reflux disease (GORD) are common in the community with important effects on health, quality of life and NHS costs. Furthermore, these problems may explain the increasing rate of oesophageal cancer. These concerns highlight the importance of appropriate investigation and management of these symptoms.
Medications that suppress gastric acid relieve symptoms in many patients; however this does not improve oesophageal function or reduce 'non-acid' reflux from the stomach. At least 1 in 4 patients have symptoms despite treatment and further management of these individuals is challenging. Conventional multichannel intraluminal impedance (MII) studies assess swallowing function and reflux, but cannot assess volume. This is important because larger volumes of food stuck in the oesophagus and failure to clear larger amounts of irritant reflux from the stomach are more likely to cause symptoms and damage to the lining of the oesophagus.
The proposed project builds on recent work at St. Thomas' in which a new MII technique was shown to detect changes in oesophageal volume. The aim is to assess whether this volume sensitive MII (vMII) is useful in clinical practice.
Patients with swallowing problems and reflux symptoms will undergo vMII and High Resolution Manometry in unison in a combined Catheter Assembly during a test meal containing barium (known as videofluoroscopy) as it is visible on x-ray. The volume of fluid stuck in the oesophagus or refluxing from the stomach will be measured by both vMII and videofluoroscopy and the problems with motility will be assessed with HRM. The results will be compared and the link between oesophageal volume, dysmotility and symptoms will be examined. Finally the studies will be repeated after treatment (videofluoroscopy being offered only males and women over 40) to see if improvements are linked to reduced volume measurements.
In routine clinical practice, successful vMII would reduce the need for barium swallows (therefore reducing exposure to radiation) and improve the ability to link oesophageal dysfunction and reflux events with symptoms, and thus guide further management in patients that fail to respond to standard treatments.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Dysphagia control
Conservative Management
Intervention: domperidone or esomeprazole (Conservative management) (Drug)
Achalasia
Long vs Short Myotomy repair of Achalasia
Intervention: Heller's Myotomy (Procedure)
GORD for surgery
Partial vs Full Fundoplication repair
Intervention: Nissen Fundoplication (Procedure)
GORD not for surgery
esomeprazole 40 mg vs no esomeprazole
Intervention: Esomeprazole 40 mg (Drug)
Outcomes
Primary Outcomes
Does vMII provide an accurate assessment of volume in disease?
Time Frame: 3 years
Does vMII assessment of volume improve the accuracy with which 'events' are associated with symp?
Time Frame: 3 years
Does symp improvement post treatment correlate with reduced 'volume events'?.
Time Frame: 3 years
Secondary Outcomes
No secondary outcomes reported