A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia

May 20, 2014 updated by: University Health Network, Toronto
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: David R Urbach, MD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

March 1, 2011

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

May 21, 2014

Last Update Submitted That Met QC Criteria

May 20, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCT-76449
  • ISRCTN05714772

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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