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Sponsors and Collaborators: |
University Health Network, Toronto Canadian Institutes of Health Research (CIHR) |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00188344 |
The purpose of this study is to compare pneumatic dilatation and laparoscopic Heller myotomy in patients with achalasia in order to learn which of these two treatments should be recommended to patients in the future.
Condition | Intervention |
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Esophageal Achalasia |
Procedure: pneumatic dilatation Procedure: laparoscopic myotomy with partial fundoplication |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia |
Estimated Enrollment: | 100 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
pneumatic dilatation
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Procedure: pneumatic dilatation
The patient is on a liquid diet for 2 days prior to procedure. A sedative and pain killer by IV are given and the throat will be sprayed with local anesthetic. The gastroenterologist may perform an endoscopy prior to the dilatation to safely guide the dilator into position. A special dilator with a small balloon will be passed down the esophagus until it meets the stomach then the balloon will be inflated with air until the narrow part of the esophagus is opened. The patient will then be assessed for any perforation of the esophagus and monitored in the post-procedure unit for a few hours.
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2: Active Comparator
Laparoscopic myotomy
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Procedure: laparoscopic myotomy with partial fundoplication
The abdomen is inflated with gas and cameras and instruments are inserted. The junction between the esophagus and stomach is identified. The muscle of the lower esophageal sphincter is divided. A portion of the stomach wall is secured to the lower esophagus. After surgery the patient is taken to the recovery room and when well enough moved to a ward. The patient may be discharged the following day.
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Achalasia is a rare disease of the esophagus. It can cause difficulty swallowing, regurgitation of swallowed food, and chest pain. In achalasia, there are two problems in the esophagus. First, the esophagus does not properly push swallowed food down towards the stomach. Second, the valve at the lower end of the esophagus, called the lower esophageal sphincter, does not relax to allow food to pass from the esophagus into the stomach.
Achalasia cannot be "cured". However, the symptoms of achalasia can be improved by treatment. Treatment is usually directed towards reducing the degree of blockage caused by the lower esophageal sphincter. the muscle of the lower esophageal sphincter can be stretched using a technique called pneumatic dilatation, or it can be divided (cut in half) during a surgical operation. The operation is called laparoscopic Heller myotomy, and is done by laparoscopic ("keyhole") surgery, where small incisions are used and patients usually stay in hospital 1-2 nights. Other treatments for achalasia, such as medications or injection of Botulinum Toxin Type A are not often used because they do not provide effective long-term improvement.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stacey Stegienko | 416-340-4800 ext 2621 | stacey.stegienko@uhnres.utoronto.ca |
Canada, Ontario | |
St. Michael's Hospital, 30 Bond Street, Suite 16 048 Cardinal Carter Wing | Recruiting |
Toronto, Ontario, Canada, M5B 1W8 | |
Contact: Paul P Kortan, MD 416-864-3094 kortanp@smh.toronto.on.ca | |
Principal Investigator: David R Urbach, MD | |
University Health Network | Recruiting |
Toronto, Ontario, Canada, M5G 2C4 | |
Contact: David R Urbach, MD 416-340-4284 david.urbach@uhn.on.ca | |
Contact: Stacey Stegienko 416-340-4800 ext 2621 stacey.stegienko@uhnres.utoronto.ca |
Principal Investigator: | David R Urbach, MD | University Health Network, Toronto |
Responsible Party: | UHN Toronto General Hospital ( Dr. David Urbach ) |
Study ID Numbers: | MCT-76449, ISRCTN05714772 |
Study First Received: | September 9, 2005 |
Last Updated: | March 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00188344 History of Changes |
Health Authority: | Canada: Health Canada |
laparoscopic myotomy pneumatic dilatation motility disorder dysphasia health-related quality of life |
Dilatation, Pathologic Gastrointestinal Diseases Quality of Life Anesthetics Anesthetics, Local Achalasia Cardiospasm |
Esophageal Motility Disorders Deglutition Disorders Digestive System Diseases Esophageal Disorder Esophageal Achalasia Esophageal Diseases |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases |
Gastrointestinal Diseases Esophageal Achalasia Esophageal Diseases |