AchalasiaNCT01933373
A Prospective Study Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia
A study testing Toupet and Dor in people with Achalasia, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Achalasia is a rare motor disorder of the gastroesophageal junction which is associated with an increased pressure of the esophageal sphincter. This leads to impairment to swallow and heartburn. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Achalasia
- What is being tested?
- Toupet and Dor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- May 2007to Dec 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- Typical achalasia according to manometry
- Eckhardt score >3
- Informed consent
Who cannot join
- Severe comorbidity precluding surgery
- Pseudo achalasia
- Inability to participate in follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Trial Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia. Comparing Toupet Versus DOR.
Achalasia is a rare motor disorder of the gastroesophageal junction which is associated with an increased pressure of the esophageal sphincter. This leads to impairment to swallow and heartburn. Esophageal myotomy, which is a surgical longitudinal incision of the esophageal muscle layer extending over to the gastroesophageal junction is the treatment of choice for achalasia. In order to prevent reflux of stomach content into the esophagus this has to be combined with an antireflux procedure where the upper part of the stomach (fundus) is wrapped around the esophagus (fundoplication). This procedure can be performed with the wrapped fundus either in front of the esophagus (Dor procedure) or behind (Toupet). The latter introduces an angulation of the esophagus, which possibly may lead to an impairment of swallowing ability and passage of food to the stomach. On the other hand, the Toupet procedure may give a better control of reflux. The primary endpoint of the study is symptoms of impaired swallowing 1 year after treatment. Secondary outcomes include reflux (pH measurements in the esophagus), radiological imaging of swallowing and quality of life.
Read the detailed description
By the end of 2012 40 patients have been enrolled and passed the one year follow up.
- Conditions
- Achalasia
- Being tested
- Toupet, Dor
- Keywords
- Randomized, Toupet, Dor, Achalasia
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToupetProcedure or surgery
Also called Laparascopic posterior partial fundoplication plus myotomy.
Laparoscopic posterior partial fundoplication plus myotomy.
DorProcedure or surgery
Also called Anterior partial fundoplication plus myotomy.
Anterior partial fundoplication plus myotomy.
| Study group | Role | What they receive |
|---|---|---|
| Toupet | Active comparator | Laparoscopic Myotomy + Toupet 180 degree partial posterior fundoplication. Receives: Procedure: Toupet |
| Dor | Experimental | Laparoscopic Myotomy + Dor anterior partial fundoplication. 90 degree partial fundoplication being the standard of care. Receives: Procedure: Dor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysphagia symptoms according to Eckhardt
Measured: up to five years follow up
Secondary outcomes (3)
Ambulatory esophageal PH
Measured: One and five years follow up
Health-related quality of life according to Velanovich
Measured: One and five years follow up
Timed barium esophagogram at 1, 2 and 5 minutes
Measured: One and five years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startMay 2007
- Primary completionDec 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ersta Hospital, Sweden
- Responsible party
- Principal investigator, Lars Lundell, Karolinska University Hospital
- Investigators
- Lars R Lundell, Professor, Principal investigator, Gastrocentrum Karolinska University Hospital, Stockholm Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933373
- Sponsor's protocol ID
- 2007/595-32
- Status last verified
- Aug 2013
- First submitted
- 19 Jun 2013
- Last updated
- 2 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kumagai K, Kjellin A, Tsai JA, Thorell A, Granqvist S, Lundell L, Hakanson B. Toupet versus Dor as a procedure to prevent reflux after cardiomyotomy for achalasia: results of a randomised clinical trial. Int J Surg. 2014;12(7):673-80. doi: 10.1016/j.ijsu.2014.05.077. Epub 2014 Jun 2.
PubMed 24892729
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia. Comparing Toupet Versus DOR.
- ClinicalTrials.gov ID
- NCT01933373
- Acronym / sponsor ID
- 2007/595-32
- Conditions
- Achalasia
- Keywords
- Randomized, Toupet, Dor, Achalasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Ersta Hospital, Sweden
- Study start
- May 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Sep 2013 (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.
Achalasia is a rare motor disorder of the gastroesophageal junction which is associated with an increased pressure of the esophageal sphincter. This leads to impairment to swallow and heartburn. Esophageal myotomy, which is a surgical longitudinal incision of the esophageal muscle layer extending over to the gastroesophageal junction is the treatment of choice for achalasia. In order to prevent reflux of stomach content into the esophagus this has to be combined with an antireflux procedure where the upper part of the stomach (fundus) is wrapped around the esophagus (fundoplication). This procedure can be performed with the wrapped fundus either in front of the esophagus (Dor procedure) or behind (Toupet). The latter introduces an angulation of the esophagus, which possibly may lead to an impairment of swallowing ability and passage of food to the stomach. On the other hand, the Toupet procedure may give a better control of reflux. The primary endpoint of the study is symptoms of impaired swallowing 1 year after treatment. Secondary outcomes include reflux (pH measurements in the esophagus), radiological imaging of swallowing and quality of life.
Detailed description
By the end of 2012 40 patients have been enrolled and passed the one year follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toupet | Active comparator | Procedure: ToupetLaparoscopic Myotomy + Toupet 180 degree partial posterior fundoplication. |
| Dor | Experimental | Procedure: DorLaparoscopic Myotomy + Dor anterior partial fundoplication. 90 degree partial fundoplication being the standard of care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18 years of age
- Typical achalasia according to manometry
- Eckhardt score >3
- Informed consent
Key exclusion criteria (3 listed)
- Severe comorbidity precluding surgery
- Pseudo achalasia
- Inability to participate in follow-up
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 |
|---|---|---|
| ToupetAlso: Laparascopic posterior partial fundoplication plus myotomy.Laparoscopic posterior partial fundoplication plus myotomy. | Procedure or surgery | Toupet |
| DorAlso: Anterior partial fundoplication plus myotomy.Anterior partial fundoplication plus myotomy. | Procedure or surgery | Dor |
Primary outcome
Dysphagia symptoms according to Eckhardt
Time frame: up to five years follow up
3 secondary outcomes
Ambulatory esophageal PH
Time frame: One and five years follow up
Health-related quality of life according to Velanovich
Time frame: One and five years follow up
Timed barium esophagogram at 1, 2 and 5 minutes
Time frame: One and five years follow up
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 2 Sep 2013.
- Derived from this study: PubMed 24892729Kumagai K, Kjellin A, Tsai JA, Thorell A, Granqvist S, Lundell L, Hakanson B. Toupet versus Dor as a procedure to prevent reflux after cardiomyotomy for achalasia: results of a randomised clinical trial. Int J Surg. 2014;12(7):673-80. doi: 10.1016/j.ijsu.2014.05.077. Epub 2014 Jun 2.
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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.
Lars R Lundell, Professor principal investigator
Gastrocentrum Karolinska University Hospital, Stockholm Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toupet and Dor in people with Achalasia, run by Karolinska University Hospital at 1 site in Sweden.
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 4 inclusion and 3 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 2 Sep 2013. 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 Sweden. 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?
Dysphagia symptoms according to Eckhardt (time frame: up to five years follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01933373, which also lists 1 linked publication.
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 2 Sep 2013.