vMII for Measurement of Oesophageal Bolus Transport and Reflux

This study has been terminated.
(prototype catheter never delivered)
Sponsor:
Information provided by:
Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00604942
First received: January 15, 2008
Last updated: July 31, 2009
Last verified: July 2009
  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:

  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.


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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Domperidone
Esomeprazole
Anti-Ulcer Agents
Antiemetics
Autonomic Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Antagonists
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014