Clinical trial NCT00188344: A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia
Official title: A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Achalasia
Keywords: laparoscopic myotomy
pneumatic dilatation
motility disorder
dysphasia
health-related quality of life
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-09-16
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: The achalasia severity questionnaire score at 1 year.
timeFrame: Baseline, M2, M6, Yrs 1 to 5
Secondary outcomes:
measure: Generic health related quality of life (SF-36)
timeFrame: baseline, M2, M6, Yrs 1 to 5
measure: Gastrointestinal disease-specific quality of life (GIQLI)
timeFrame: baseline, M2, M6, Yrs 1 to 5
measure: Measures of esophageal physiology
timeFrame: baseline, M6
measure: Gastroesophageal reflux as measured by ambulatory 24-hr esophageal pH measurement
timeFrame: M6
measure: Clinical outcomes of care including short term outcomes, major complications, and long-term clinical outcomes.
timeFrame: Yrs 1 to 5
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital, 30 Bond Street, Suite 16 048 Cardinal Carter Wing
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: David R Urbach, MD
role: PRINCIPAL_INVESTIGATOR
References: