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
Esophageal Achalasia	Procedure: pneumatic dilatation  Procedure: laparoscopic myotomy with partial fundoplication

Further Study Details: 

Primary Outcomes: The achalasia severity questionnaire score at 1 year.
Secondary Outcomes: Generic health related quality of life (SF-36); Gastrointestinal disease-specific quality of life (GIQLI); Measures of esophageal physiology; Gastroesophageal reflux as measured by ambulatory 24-hr esophageal pH measurement; Clinical outcomes of care including short term outcomes, major complications, and long-term clinical outcomes.
Expected Total Enrollment:  100

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 above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00188344

Julie Harnish      416-340-4800  Ext. 8316    jharnish@uhnres.utoronto.ca

Canada, Ontario
      St. Michael''''s Hospital, 30 Bond Street, Suite 16 048 Cardinal Carter Wing, Toronto,  Ontario,  M5B 1W8,  Canada
      University Health Network, Toronto,  Ontario,  M5G 2C4,  Canada

Study chairs or principal investigators

David R Urbach, MD,  Principal Investigator,  UNIVERSITY HEALTH NETWORK   

Study ID Numbers:  MCT-76449; ISRCTN05714772
Last Updated:  September 15, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00188344
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-20