A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia

A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia
This study is currently recruiting participants.
Verified January 2010 by University Health Network, Toronto

First Received on September 9, 2005.  
Last Updated on January 22, 2010  
History of Changes
Sponsor: University Health Network, Toronto
Collaborator: Canadian Institutes of Health Research (CIHR)
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
Esophageal Achalasia Procedure: pneumatic dilatation
Procedure: laparoscopic myotomy with partial fundoplication

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia

Resource links provided by NLM:

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

  • The achalasia severity questionnaire score at 1 year. [ Time Frame: Baseline, M2, M6, Yrs 1 to 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • Generic health related quality of life (SF-36) [ Time Frame: baseline, M2, M6, Yrs 1 to 5 ] [ Designated as safety issue: No ]
  • Gastrointestinal disease-specific quality of life (GIQLI) [ Time Frame: baseline, M2, M6, Yrs 1 to 5 ] [ Designated as safety issue: No ]
  • Measures of esophageal physiology [ Time Frame: baseline, M6 ] [ Designated as safety issue: No ]
  • Gastroesophageal reflux as measured by ambulatory 24-hr esophageal pH measurement [ Time Frame: M6 ] [ Designated as safety issue: No ]
  • Clinical outcomes of care including short term outcomes, major complications, and long-term clinical outcomes. [ Time Frame: Yrs 1 to 5 ] [ Designated as safety issue: No ]

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)


Assigned Interventions
Active Comparator: 1

pneumatic dilatation
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.

Active Comparator: 2

Laparoscopic myotomy
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.

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 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:

  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188344

Contact: Julie Takata, MA 416-340-4800 ext 8316 julie.takata@uhnresearch.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: Julie Takata, MA     416-340-4800 ext 8316     julie.takata@uhnresearch.ca    
Sponsors and Collaborators
University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)
Principal Investigator: David R Urbach, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Dr. David Urbach, UHN Toronto General Hospital
ClinicalTrials.gov Identifier: NCT00188344    
History of Changes
Other Study ID Numbers: MCT-76449, ISRCTN05714772
Study First Received: September 9, 2005
Last Updated: January 22, 2010
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:

laparoscopic myotomy
pneumatic dilatation
motility disorder
health-related quality of life

Additional relevant MeSH terms:

Dilatation, Pathologic
Esophageal Achalasia
Esophageal Diseases
Pathological Conditions, Anatomical
Esophageal Motility Disorders
Deglutition Disorders
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 21, 2012

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