vMII for Measurement of Oesophageal Bolus Transport and Reflux

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.

Conditions

• Achalasia
• GORD

Interventions

PROCEDURE

Heller's Myotomy

Long vs Short Heller's Myotomy for Achalasia

PROCEDURE

Nissen Fundoplication

Partial vs Full Fundoplication for GORD

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

DRUG

Esomeprazole 40 mg

Esomeprazole vs no esomeprazole for GORD not referred for surgery

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust

  lead OTHER

Principal Investigators

• Mark Fox, MD · Honorary Consultant and Senior Lecturer

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-11-30

Primary Completion

2010-10-31

Completion

2010-10-31

Countries

• United Kingdom

Study Locations