Contact information
Type
Scientific
Primary contact
Dr David Robert Urbach
ORCID ID
Contact details
Toronto General Hospital
200 Elizabeth Street
Eaton Wing 9EN-236A
Toronto
Ontario
M5G 2C4
Canada
+1 416 340 4284
david.urbach@uhn.on.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00188344
Protocol/serial number
MCT-76449
Study information
Scientific title
A randomised comparison of laparoscopic myotomy and pneumatic dilatation for
achalasia
Acronym
Study hypothesis
In patients with achalasia, is symptom relief at one year better with laparoscopic Heller myotomy with partial fundoplication, or pneumatic dilatation?
Ethics approval
University Health Network Research Ethics Board, approval gained initially on May 19, 2005; renewed and continued approval until May 19, 2007 (reference number: 05-0065-A).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Achalasia
Intervention
Intervention Arm #1 (primary achalasia) will receive pneumatic dilatation
Intervention Arm #2 (primary achalasia) will receive Heller myotomy with partial fundoplication
Intervention Arm #3 (recurrent achalasia) will receive pneumatic dilatation
Intervention Arm #4 (recurrent achalasia) will receive Heller myotomy with partial fundoplication
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The achalasia severity questionnaire score at 1 year.
Secondary outcome measures
1. Generic health related quality of life (SF-36)
2. Gastrointestinal disease-specific quality of life (GIQLI)
3. Measures of oesophageal physiology (lower oesophageal sphincter pressure, mean amplitude of oesophageal contractions, presence of any contractions after intervention)
4. Gastroesophageal reflux as measured by ambulatory 24-hour oesophageal pH measurement
5. Oesophageal emptying, as quantified by times barium oesophagram
6. Clinical outcomes of care including short term outcomes (i.e. death within 30 days of treatment); major complications (i.e. oesophageal perforation, prolonged hospitalisation, myocardial infarction etc.) and long-term clinical outcomes (i.e. survival after randomisation, incidence of oesophageal cancer, reintervention, clinical gastroesophageal reflux disease, use of antisecretory medications)
Overall trial start date
01/08/2005
Overall trial end date
31/08/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Persons of either sex age groups 18 and up
2. Clinical diagnosis of achalasia by a physician
3. Manometric diagnosis of achalasia including both: incomplete relaxation of the lower oesophageal sphincter during swallowing (<80% of elevation over intragastric pressure) and absence of oesophageal peristalsis (peristalsis in <20% of initiated contractions)
4. Facility with English, ability to complete English-language questionnaires
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Pseudoachalasia: oesophageal carcinoma; oesophageal stricture; previous oesophageal or gastric surgery; previous instrumentation of the lower oesophageal sphincter i.e. suture, polymer injection, silicone band
2. Previous gastric or oesophageal surgery: fundoplication; Heller myotomy; gastric resection; vagotomy with or without gastric drainage
3. Age 17 years or less
4. Pregnancy
5. 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
Recruitment start date
01/08/2005
Recruitment end date
31/08/2012
Locations
Countries of recruitment
Canada
Trial participating centre
Toronto General Hospital
Toronto, Ontario
M5G 2C4
Canada
Sponsor information
Organisation
University Health Network, Toronto (Canada)
Sponsor details
200 Elizabeth Street
Toronto
Ontario
M5G 2C4
Canada
+1 416 340 4800
carolynm@uhnresearch.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-76449)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary