Status:
UNKNOWN
A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Esophageal Achalasia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 patient...
Detailed Description
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 eso...
Eligibility Criteria
Inclusion
- Clinical diagnosis of achalasia by a physician
- manometric diagnosis of achalasia including both: Incomplete relaxation of the lower esophageal sphincter during swallowing (\<80% of elevation over intragastric pressure and absence of esophageal peristalsis (peristalsis in \<20% of initiated contractions)
- Facility with English, ability to complete English language questionnaires
Exclusion
- Pseudoachalasia: esophageal carcinoma; esophageal stricture; previous esophageal or gastric surgery; previous instrumentation of the lower esophageal sphincter i.e. suture, polymer injection, silicone band
- Previous gastric or esophageal surgery: fundoplication; Heller myotomy; gastric resection; vagotomy with or without gastric drainage
- Age 17 year or less
- Pregnancy
- Presence of severe comorbid illness: unstable angina; recent myocardial infarction (\<6 months), cancer (except integumentary), unless free of disease for more than 5 years; end stage renal disease; previous stroke with cognitive, motor speech, or swallowing deficit persisting longer than one month; severe respiratory disease; cognitive impairment
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00188344
Start Date
September 1 2005
End Date
March 1 2015
Last Update
May 21 2014
Active Locations (2)
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1
St. Michael's Hospital, 30 Bond Street, Suite 16 048 Cardinal Carter Wing
Toronto, Ontario, Canada, M5B 1W8
2
University Health Network
Toronto, Ontario, Canada, M5G 2C4