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A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00188344
Recruitment Status : Unknown
Verified May 2014 by University Health Network, Toronto.
Recruitment status was:  Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : May 21, 2014
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University Health Network, Toronto

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 patients in the future.

Condition or disease Intervention/treatment Phase
Esophageal Achalasia Procedure: pneumatic dilatation Procedure: laparoscopic myotomy with partial fundoplication Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia
Study Start Date : September 2005
Actual Primary Completion Date : March 2011
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. The achalasia severity questionnaire score at 1 year. [ Time Frame: Baseline, M2, M6, Yrs 1 to 5 ]

Secondary Outcome Measures :
  1. Generic health related quality of life (SF-36) [ Time Frame: baseline, M2, M6, Yrs 1 to 5 ]
  2. Gastrointestinal disease-specific quality of life (GIQLI) [ Time Frame: baseline, M2, M6, Yrs 1 to 5 ]
  3. Measures of esophageal physiology [ Time Frame: baseline, M6 ]
  4. Gastroesophageal reflux as measured by ambulatory 24-hr esophageal pH measurement [ Time Frame: M6 ]
  5. Clinical outcomes of care including short term outcomes, major complications, and long-term clinical outcomes. [ Time Frame: Yrs 1 to 5 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00188344

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Canada, Ontario
St. Michael's Hospital, 30 Bond Street, Suite 16 048 Cardinal Carter Wing
Toronto, Ontario, Canada, M5B 1W8
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)
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Principal Investigator: David R Urbach, MD University Health Network, Toronto
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Responsible Party: University Health Network, Toronto Identifier: NCT00188344    
Other Study ID Numbers: MCT-76449
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014
Keywords provided by University Health Network, Toronto:
laparoscopic myotomy
pneumatic dilatation
motility disorder
health-related quality of life
Additional relevant MeSH terms:
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Esophageal Achalasia
Dilatation, Pathologic
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases