vMII for Measurement of Oesophageal Bolus Transport and Reflux

• Status: Terminated
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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:

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

2. 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:

1. the oesophageal dysfunction that results in bolus escape

2. the abnormal events at the gastro-oesophageal junction (reflux barrier) that allow reflux to occur.

with a reduction in oesophageal volume retention / reflux.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Treatments: Domperidone; Esomeprazole

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)