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Sponsored by: |
Guy's and St Thomas' NHS Foundation Trust |
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Information provided by: | Guy's and St Thomas' NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT00604942 |
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:
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:
with a reduction in oesophageal volume retention / reflux.
Condition | Intervention |
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Achalasia GORD |
Procedure: Heller's Myotomy Procedure: Nissen Fundoplication Drug: domperidone or esomeprazole (Conservative management) Drug: Esomeprazole 40 mg |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Single Blind (Investigator), Parallel Assignment |
Official Title: | Volume Sensitive Multichannel Intraluminal Impedance (vMII) for the Measurement of Oesophageal Bolus Transport and Reflux |
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 |
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Achalasia: Experimental
Long vs Short Myotomy repair of Achalasia
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Procedure: Heller's Myotomy
Long vs Short Heller's Myotomy for Achalasia
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Dysphagia control: Experimental
Conservative Management
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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
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GORD for surgery: Experimental
Partial vs Full Fundoplication repair
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Procedure: Nissen Fundoplication
Partial vs Full Fundoplication for GORD
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GORD not for surgery: Experimental
esomeprazole 40 mg vs no esomeprazole
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Drug: Esomeprazole 40 mg
Esomeprazole vs no esomeprazole for GORD not referred for surgery
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rami Sweis, MBChB | +44 2071884194 | ramisweis@hotmail.com |
United Kingdom | |
Oesophageal Laboratory, GSTT | Recruiting |
London, United Kingdom, SE1 7EH | |
Principal Investigator: Rami Sweis, MBChB |
Principal Investigator: | Mark Fox, MD | Honorary Consultant and Senior Lecturer |
Responsible Party: | Guy's and St Thomas' NHS Foundation Trust ( Dr Mark Fox ) |
Study ID Numbers: | 07/H0802/73 |
Study First Received: | January 15, 2008 |
Last Updated: | January 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00604942 |
Health Authority: | United Kingdom: Research Ethics Committee |
Oesophagus Dysphagia Impedance High Resolution Manometry |
Peristalsis Contractile Pressure Coordination of contraction Bolus transport |
Deglutition Disorders Dopamine Domperidone Esophageal disorder Omeprazole |
Esophageal Achalasia Esophageal Diseases Cardiospasm Achalasia |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Antiemetics Enzyme Inhibitors Dopamine Antagonists |
Pharmacologic Actions Autonomic Agents Therapeutic Uses Anti-Ulcer Agents Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |