Esophageal AchalasiaNCT00490750
Laparoscopic Dor Versus Toupet Fundoplication for the Treatment of Idiopathic Esophageal Achalasia
A study testing Dor fundoplication and Toupet fundoplication in people with Esophageal Achalasia, run by L. Michael Brunt at 1 site in United States.
Trial summary
The primary aim of this study is to test the hypothesis that Heller myotomy and Toupet fundoplication result in a lower rate of reflux symptoms and positive 24-hour pH testing when compared to Heller myotomy and Dor fundoplication. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Esophageal Achalasia
- What is being tested?
- Dor fundoplication and Toupet fundoplication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Aug 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of Achalasia
Who cannot join
- Prior heller myotomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Randomized Prospective Trial of Laparoscopic Heller Myotomy and Partial Fundoplication for the Treatment of Idiopathic Esophageal Achalasia
The primary aim of this study is to test the hypothesis that Heller myotomy and Toupet fundoplication result in a lower rate of reflux symptoms and positive 24-hour pH testing when compared to Heller myotomy and Dor fundoplication.
Read the detailed description
Idiopathic achalasia is an uncommon motor disorder of the esophagus which occasionally requires surgical intervention. Although there are several controversial aspects of therapy for achalasia, laparoscopic myotomy is emerging as the procedure of choice. Several studies report having good to excellent outcomes following a laparoscopic procedure in approximately 90% of patients. However, a main deterrent to long-term success is the development of gastroesophageal reflux disease (GERD) despite the use of an antireflux procedure. For this reason, most surgeons add a partial fundoplication to the myotomy. The gastric fundus can either be wrapped anterior to the esophagus (Dor fundoplication), or posterior to the esophagus (Toupet fundoplication). Currently, the type of fundoplication is determined by surgeon's choice. There exists no systematic comparison of the two procedures. This multicenter, randomized study aims to evaluate patient outcomes following myotomy and Dor versus Toupet fundoplication.
- Conditions
- Esophageal Achalasia
- Being tested
- Dor fundoplication, Toupet fundoplication
- Keywords
- Heller Dor, Heller Toupet, Myotomy
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dor fundoplicationProcedure or surgery
Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Dor fundoplication
Toupet fundoplicationProcedure or surgery
Subjects are randomized to undergo Heller myotomy followed by Laparoscopic Toupet fundoplication
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Dor fundoplication | Active comparator | Heller myotomy followed by Dor fundoplication Receives: Procedure: Dor fundoplication |
| Laparoscopic Toupet fundoplication | Active comparator | Heller myotomy followed by Toupet fundoplication Receives: Procedure: Toupet fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcomes are 24 hour pH testing results
Measured: pH testing at 6-12 months after surgical treatment
Secondary outcomes (1)
Symptomatic response measured by detailed patient questionnaire and results of barium swallow radiographs
Measured: 6-12 months after surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2007 (estimated)
- Study startMar 2003
- Primary completionAug 2011
- Study completionAug 2011
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.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- L. Michael Brunt
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Northwestern University, University of Oregon, Duke University
- Responsible party
- Sponsor-investigator, L. Michael Brunt, Washington University School of Medicine
- Investigators
- L. Michael Brunt, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490750
- Sponsor's protocol ID
- 03-0241
- Status last verified
- Dec 2015
- First submitted
- 21 Jun 2007
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Trial of Laparoscopic Heller Myotomy and Partial Fundoplication for the Treatment of Idiopathic Esophageal Achalasia
- ClinicalTrials.gov ID
- NCT00490750
- Acronym / sponsor ID
- 03-0241
- Conditions
- Esophageal Achalasia
- Keywords
- Heller Dor, Heller Toupet, Myotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- L. Michael BruntUniversity, hospital or other
- Collaborators
- University of Washington, Northwestern University, University of Oregon, Duke University
- Study start
- Mar 2003
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 25 Jun 2007 (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 primary aim of this study is to test the hypothesis that Heller myotomy and Toupet fundoplication result in a lower rate of reflux symptoms and positive 24-hour pH testing when compared to Heller myotomy and Dor fundoplication.
Detailed description
Idiopathic achalasia is an uncommon motor disorder of the esophagus which occasionally requires surgical intervention. Although there are several controversial aspects of therapy for achalasia, laparoscopic myotomy is emerging as the procedure of choice. Several studies report having good to excellent outcomes following a laparoscopic procedure in approximately 90% of patients. However, a main deterrent to long-term success is the development of gastroesophageal reflux disease (GERD) despite the use of an antireflux procedure. For this reason, most surgeons add a partial fundoplication to the myotomy. The gastric fundus can either be wrapped anterior to the esophagus (Dor fundoplication), or posterior to the esophagus (Toupet fundoplication). Currently, the type of fundoplication is determined by surgeon's choice. There exists no systematic comparison of the two procedures. This multicenter, randomized study aims to evaluate patient outcomes following myotomy and Dor versus Toupet fundoplication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Dor fundoplication | Active comparator | Procedure: Dor fundoplicationHeller myotomy followed by Dor fundoplication |
| Laparoscopic Toupet fundoplication | Active comparator | Procedure: Toupet fundoplicationHeller myotomy followed by Toupet fundoplication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Achalasia
Key exclusion criteria (1 listed)
- Prior heller myotomy
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 |
|---|---|---|
| Dor fundoplicationSubjects are randomized to undergo Heller myotomy followed by Laparoscopic Dor fundoplication | Procedure or surgery | Laparoscopic Dor fundoplication |
| Toupet fundoplicationSubjects are randomized to undergo Heller myotomy followed by Laparoscopic Toupet fundoplication | Procedure or surgery | Laparoscopic Toupet fundoplication |
Primary outcome
Primary outcomes are 24 hour pH testing results
Time frame: pH testing at 6-12 months after surgical treatment
1 secondary outcome
Symptomatic response measured by detailed patient questionnaire and results of barium swallow radiographs
Time frame: 6-12 months after surgical intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
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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.
L. Michael Brunt, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dor fundoplication and Toupet fundoplication in people with Esophageal Achalasia, run by L. Michael Brunt at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary outcomes are 24 hour pH testing results (time frame: pH testing at 6-12 months after surgical treatment). 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 9 Dec 2015.