vMII for Measurement of Oesophageal Bolus Transport and Reflux (vMII)
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.
|Achalasia GORD||Procedure: Heller's Myotomy Procedure: Nissen Fundoplication Drug: domperidone or esomeprazole (Conservative management) Drug: Esomeprazole 40 mg|
|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|
- 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 ]
|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)|
Long vs Short Myotomy repair of Achalasia
Procedure: Heller's Myotomy
Long vs Short Heller's Myotomy for Achalasia
Experimental: Dysphagia control
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604942
|Oesophageal Laboratory, GSTT|
|London, United Kingdom, SE1 7EH|
|Principal Investigator:||Mark Fox, MD||Honorary Consultant and Senior Lecturer|