A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188344
First received: September 9, 2005
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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 ]

Enrollment: 56
Study Start Date: September 2005
Estimated Study Completion Date: March 2015
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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)
Investigators
Principal Investigator: David R Urbach, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00188344     History of Changes
Other Study ID Numbers: MCT-76449, ISRCTN05714772
Study First Received: September 9, 2005
Last Updated: May 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
laparoscopic myotomy
pneumatic dilatation
motility disorder
dysphasia
health-related quality of life

Additional relevant MeSH terms:
Dilatation, Pathologic
Esophageal Achalasia
Pathological Conditions, Anatomical
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 19, 2014