AchalasiaPhase 2NCT02086669
Pneumatic Dilatation or Surgical Myotomy for Achalasia
A Phase 2 study testing Pneumatic dilatation and Laparoscopic myotomy in people with Achalasia, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Achalasia
- What is being tested?
- Pneumatic dilatation and Laparoscopic myotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2000to Jan 2014
- Phase
- Phase 2
- 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
- Newly diagnosed achalasia
- Age 18-80 years
- Informed consent
Who cannot join
- Previous treatment for achalasia.
- Stage IV achalasia.
- Unwillingness to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study to Compare Pneumatic Dilatation With Surgical Myotomy for Treatment of Achalasia - Long Term Follow up
Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.
Read the detailed description
Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.
During follow up patients have been interviewed with regular intervals, by use validated questionnaires. The level of symptom control has been assessed as well as the scoring cumulative incidence of treatment failures.
Health Related Quality of Life (HRQL) has been regularly checked.
- Conditions
- Achalasia
- Being tested
- Pneumatic dilatation, Laparoscopic 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.
Pneumatic dilatationProcedure or surgery
Laparoscopic myotomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pneumatic dilatation | Experimental | Repetitive pneumatic dilatation as the initial treatment followed by repetitive dilatation in case of dysphagia recurrence. Receives: Procedure: Pneumatic dilatation |
| Surgical myotomy | Active comparator | Laparoscopic myotomy and subsequent follow up. Receives: Procedure: Laparoscopic myotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failures
Treatment failure is defined as a Composite variabel containing a number of different Clinically relevant outcomes.
Measured: At least five years after intervention
Secondary outcomes (3)
Dysphagia scoring
Dysphagia score according to standardized, validated scoring system.
Measured: At least five years after intervention
Health Related Quality of Life
Universally adopted and validated instruments are used.
Measured: At least five years after intervention.
Direct medical costs.
Charges for the average hospital in respective countries.
Measured: At least five years after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startJan 2000
- Primary completionJan 2009
- Study completionJan 2014
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.
- More trials run by Karolinska University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Principal investigator, Lars Lundell, Karolinska University Hospital
- Investigators
- Lars Lundell, Professor, Study chair, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086669
- Sponsor's protocol ID
- S500-00
- Status last verified
- Apr 2016
- First submitted
- 3 Mar 2014
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Persson J, Johnsson E, Kostic S, Lundell L, Smedh U. Treatment of achalasia with laparoscopic myotomy or pneumatic dilatation: long-term results of a prospective, randomized study. World J Surg. 2015 Mar;39(3):713-20. doi: 10.1007/s00268-014-2869-4.
PubMed 25409838
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study to Compare Pneumatic Dilatation With Surgical Myotomy for Treatment of Achalasia - Long Term Follow up
- ClinicalTrials.gov ID
- NCT02086669
- Acronym / sponsor ID
- S500-00
- Conditions
- Achalasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Study start
- Jan 2000
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Mar 2014 (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.
Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.
Detailed description
Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.
During follow up patients have been interviewed with regular intervals, by use validated questionnaires. The level of symptom control has been assessed as well as the scoring cumulative incidence of treatment failures.
Health Related Quality of Life (HRQL) has been regularly checked.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumatic dilatation | Experimental | Procedure: Pneumatic dilatationRepetitive pneumatic dilatation as the initial treatment followed by repetitive dilatation in case of dysphagia recurrence. |
| Surgical myotomy | Active comparator | Procedure: Laparoscopic myotomyLaparoscopic myotomy and subsequent follow up. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly diagnosed achalasia
- Age 18-80 years
- Informed consent
Key exclusion criteria (3 listed)
- Previous treatment for achalasia.
- Stage IV achalasia.
- Unwillingness to participate.
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 dilatation | Procedure or surgery | Pneumatic dilatation |
| Laparoscopic myotomy | Procedure or surgery | Surgical myotomy |
Primary outcome
Treatment failures
Time frame: At least five years after intervention
Treatment failure is defined as a Composite variabel containing a number of different Clinically relevant outcomes.
3 secondary outcomes
Dysphagia scoring
Time frame: At least five years after intervention
Health Related Quality of Life
Time frame: At least five years after intervention.
Direct medical costs.
Time frame: At least five years after 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 5 Apr 2016.
- Derived from this study: PubMed 25409838Persson J, Johnsson E, Kostic S, Lundell L, Smedh U. Treatment of achalasia with laparoscopic myotomy or pneumatic dilatation: long-term results of a prospective, randomized study. World J Surg. 2015 Mar;39(3):713-20. doi: 10.1007/s00268-014-2869-4.
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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.
Lars Lundell, Professor study chair
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pneumatic dilatation and Laparoscopic myotomy 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 3 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 5 Apr 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Treatment failures (time frame: At least five years after intervention). 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 NCT02086669, 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 5 Apr 2016.