Esophageal AchalasiaNCT00188344
A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia
A study testing pneumatic dilatation and laparoscopic myotomy with partial fundoplication in people with Esophageal Achalasia, run by University Health Network, Toronto at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Achalasia
- What is being tested?
- pneumatic dilatation and laparoscopic myotomy with partial fundoplication
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2005to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Michael's Hospital, 30 Bond Street, Suite 16 048 Cardinal Carter Wing
Toronto, Ontario, M5B 1W8
University Health Network
Toronto, Ontario, M5G 2C4
About this study
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.
Read the 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.
- Conditions
- Esophageal Achalasia
- Being tested
- pneumatic dilatation, laparoscopic myotomy with partial fundoplication
- Keywords
- laparoscopic myotomy, pneumatic dilatation, motility disorder, dysphasia, health-related quality of life
- Medical subject headings
- Esophageal Achalasia, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumatic dilatationProcedure or surgery
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.
laparoscopic myotomy with partial fundoplicationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | pneumatic dilatation Receives: Procedure: pneumatic dilatation |
| 2 | Active comparator | Laparoscopic myotomy Receives: Procedure: laparoscopic myotomy with partial fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
The achalasia severity questionnaire score at 1 year.
Measured: Baseline, M2, M6, Yrs 1 to 5
Secondary outcomes (5)
Generic health related quality of life (SF-36)
Measured: baseline, M2, M6, Yrs 1 to 5
Gastrointestinal disease-specific quality of life (GIQLI)
Measured: baseline, M2, M6, Yrs 1 to 5
Measures of esophageal physiology
Measured: baseline, M6
Gastroesophageal reflux as measured by ambulatory 24-hr esophageal pH measurement
Measured: M6
Clinical outcomes of care including short term outcomes, major complications, and long-term clinical outcomes.
Measured: Yrs 1 to 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionMar 2011
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AchalasiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- David R Urbach, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188344
- Sponsor's protocol ID
- MCT-76449
- Other IDs
- ISRCTN05714772
- Status last verified
- May 2014
- First submitted
- 9 Sep 2005
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia
- ClinicalTrials.gov ID
- NCT00188344
- Acronym / sponsor ID
- MCT-76449
- Conditions
- Esophageal Achalasia
- Keywords
- laparoscopic myotomy, pneumatic dilatation, motility disorder, dysphasia, health-related quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2005
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2015 (estimated)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: pneumatic dilatationpneumatic dilatation |
| 2 | Active comparator | Procedure: laparoscopic myotomy with partial fundoplicationLaparoscopic myotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pneumatic dilatationThe 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. | Procedure or surgery | 1 |
| laparoscopic myotomy with partial fundoplicationThe 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. | Procedure or surgery | 2 |
Primary outcome
The achalasia severity questionnaire score at 1 year.
Time frame: Baseline, M2, M6, Yrs 1 to 5
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Urbach, MD principal investigator
University Health Network, Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pneumatic dilatation and laparoscopic myotomy with partial fundoplication in people with Esophageal Achalasia, run by University Health Network, Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The achalasia severity questionnaire score at 1 year. (time frame: Baseline, M2, M6, Yrs 1 to 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2014.