Overview

This trial is active, not recruiting.

Condition esophageal achalasia
Treatments pneumatic dilatation, laparoscopic myotomy with partial fundoplication
Sponsor University Health Network, Toronto
Collaborator Canadian Institutes of Health Research (CIHR)
Start date September 2005
End date March 2011
Trial size 56 participants
Trial identifier NCT00188344, ISRCTN05714772, MCT-76449

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
pneumatic dilatation
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)
Laparoscopic myotomy
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 Outcomes

Measure
The achalasia severity questionnaire score at 1 year.
time frame: Baseline, M2, M6, Yrs 1 to 5

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia
Principal investigator David R Urbach, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.