Esophageal AchalasiaPOETANCT02518542
Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia
A study testing Endoscopic intervention A, Endoscopic intervention B and Endoscopic intervention C in people with Esophageal Achalasia, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Achalasia is an esophageal motility disorder, which leads to clinical symptoms such as dysphagia, regurgitation, chest pain and consecutive weight loss. Although conventional treatment such as laparoscopic Heller myotomy (LHM) and balloon dilatation (BD) can provide sufficient symptom relief in many patients, both… 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?
- Endoscopic intervention A, Endoscopic intervention B and Endoscopic intervention C
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2014to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Confirmed diagnosis of achalsia, hypertensive lower esophageal sphincter, nutcracker esophagus, or diffuse esophageal spasm
Who cannot join
- Contraindication for EGD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Department of Surgery, Medical University of Vienna contact
sebastian.schoppmann@meduniwien.ac.at; erwin.rieder@meduniwien.ac.at
Austria1 site, 1 recruiting
- Recruiting
Department of Surgery, Medical University of Vienna
Vienna, 1090
Sebastian F Schoppmann, MD, +43 1 40400 ext. 5621, sebastian.schoppmann@meduniwien.ac.at
Erwin Rieder, MD, +43 1 40400 ext. 5621, erwin.rieder@meduniwien.ac.at
About this study
Official title: Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) as Additional Endoscopic Treatment Options for Achalasia and Other Esophageal Motility Disorders
Achalasia is an esophageal motility disorder, which leads to clinical symptoms such as dysphagia, regurgitation, chest pain and consecutive weight loss.
Although conventional treatment such as laparoscopic Heller myotomy (LHM) and balloon dilatation (BD) can provide sufficient symptom relief in many patients, both interventions have their individual drawbacks. Additionally, treatment after failed LHM or BD can be challenging and in few might even lead to esophagectomy.
Read more
Per oral endoscopic myotomy (POEM) and prolonged dilatation (PRD) are two novel endoscopically performed therapeutic options for achalasia and other esophageal motility disorders. Both not only appear to provide good results, when performed as initial treatment but also might be an excellent option after e.g failed LHM.
The purpose of this study is to evaluate the long-term efficacy of four different treatment options, such as POEM, PRD with stent-fixation, PD and conventional LHM for achalasia in an individualized treatment setting.
- Conditions
- Esophageal Achalasia
- Being tested
- Endoscopic intervention A, Endoscopic intervention B, Endoscopic intervention C, Laparoscopic Surgery
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic intervention AProcedure or surgery
POEM: Per oral endoscopic myotomy
Endoscopic intervention BProcedure or surgery
PRD: Prolonged dilatation by temporary implantation of large diameter stent . Stents are additionally attached to the esophageal wall by different technical options.
Endoscopic intervention CProcedure or surgery
Endoscopic balloon dilatation
Laparoscopic SurgeryProcedure or surgery
Laparoscopic Heller myotomy
| Study group | Role | What they receive |
|---|---|---|
| Per oral endoscopic therapy A | Active comparator | Per oral endoscopic myotomy Receives: Procedure: Endoscopic intervention A |
| Per oral endoscopic therapy B | Active comparator | Prolonged dilatation by implantation of large diameter stents. Receives: Procedure: Endoscopic intervention B |
| Per oral endoscopic therapy C | Active comparator | Dilatation Receives: Procedure: Endoscopic intervention C |
| Laparoscopic surgery | Active comparator | Laparoscopic Heller myotomy Receives: Procedure: Laparoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achalasia specific symptoms according to the Eckardt score (0-12)
Eckardt score: Weight loss 0kg (0), less than 5kg (1), 5-10 kg (2), more than 10 kg (3); Dysphagia none(0), occasional (1), daily (2), every meal (3); Regurgitation none(0), occasional (1), daily (2), every meal (3); Retrosternal pain none(0), occasional (1), daily (2), every meal (3)
Measured: 6 mo post-op
Secondary outcomes (4)
Barium column height (cm) in esophagogram
Measured: 6 mo post-op
Resting pressure (mmHg) at the lower esophageal sphincter
Measured: 6 mo post-op
Stent migration
Analysis: On the first postoperative day a routine esophagogram will be used to evaluate the appropriate location of the esophageal stent. Early distal stent dislocation/migration into the stomach will be registered.
Measured: p.o. day 1
Percent of time (min)/24h that the pH is less than 4.0 in pH-metry
Measured: 6 mo post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2024 (estimated)
- Study completionJun 2027 (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 Medical University of ViennaThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erwin Rieder, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518542
- Sponsor's protocol ID
- POETA
- Acronym
- POETA
- Status last verified
- Aug 2015
- First submitted
- 8 Dec 2014
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) as Additional Endoscopic Treatment Options for Achalasia and Other Esophageal Motility Disorders
- ClinicalTrials.gov ID
- NCT02518542
- Acronym / sponsor ID
- POETA / POETA
- Conditions
- Esophageal Achalasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 Aug 2015 (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 an esophageal motility disorder, which leads to clinical symptoms such as dysphagia, regurgitation, chest pain and consecutive weight loss.
Although conventional treatment such as laparoscopic Heller myotomy (LHM) and balloon dilatation (BD) can provide sufficient symptom relief in many patients, both interventions have their individual drawbacks. Additionally, treatment after failed LHM or BD can be challenging and in few might even lead to esophagectomy.
Per oral endoscopic myotomy (POEM) and prolonged dilatation (PRD) are two novel endoscopically performed therapeutic options for achalasia and other esophageal motility disorders. Both not only appear to provide good results, when performed as initial treatment but also might be an excellent option after e.g failed LHM.
The purpose of this study is to evaluate the long-term efficacy of four different treatment options, such as POEM, PRD with stent-fixation, PD and conventional LHM for achalasia in an individualized treatment setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Per oral endoscopic therapy A | Active comparator | Procedure: Endoscopic intervention APer oral endoscopic myotomy |
| Per oral endoscopic therapy B | Active comparator | Procedure: Endoscopic intervention BProlonged dilatation by implantation of large diameter stents. |
| Per oral endoscopic therapy C | Active comparator | Procedure: Endoscopic intervention CDilatation |
| Laparoscopic surgery | Active comparator | Procedure: Laparoscopic SurgeryLaparoscopic Heller myotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed diagnosis of achalsia, hypertensive lower esophageal sphincter, nutcracker esophagus, or diffuse esophageal spasm
Key exclusion criteria (1 listed)
- Contraindication for EGD
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 |
|---|---|---|
| Endoscopic intervention APOEM: Per oral endoscopic myotomy | Procedure or surgery | Per oral endoscopic therapy A |
| Endoscopic intervention BPRD: Prolonged dilatation by temporary implantation of large diameter stent . Stents are additionally attached to the esophageal wall by different technical options. | Procedure or surgery | Per oral endoscopic therapy B |
| Endoscopic intervention CEndoscopic balloon dilatation | Procedure or surgery | Per oral endoscopic therapy C |
| Laparoscopic SurgeryLaparoscopic Heller myotomy | Procedure or surgery | Laparoscopic surgery |
Primary outcome
Achalasia specific symptoms according to the Eckardt score (0-12)
Time frame: 6 mo post-op
Eckardt score: Weight loss 0kg (0), less than 5kg (1), 5-10 kg (2), more than 10 kg (3); Dysphagia none(0), occasional (1), daily (2), every meal (3); Regurgitation none(0), occasional (1), daily (2), every meal (3); Retrosternal pain none(0), occasional (1), daily (2), every meal (3)
4 secondary outcomes
Barium column height (cm) in esophagogram
Time frame: 6 mo post-op
Resting pressure (mmHg) at the lower esophageal sphincter
Time frame: 6 mo post-op
Stent migration
Time frame: p.o. day 1
Percent of time (min)/24h that the pH is less than 4.0 in pH-metry
Time frame: 6 mo post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 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.
Department of Surgery, Medical University of Vienna contact
sebastian.schoppmann@meduniwien.ac.at; erwin.rieder@meduniwien.ac.at
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic intervention A, Endoscopic intervention B and Endoscopic intervention C in people with Esophageal Achalasia, run by Medical University of Vienna at 1 site in Austria.
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: looking for participants now, as of the sponsor's last update on 10 Aug 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Department of Surgery, Medical University of Vienna (+43 1 40400 ext. 5621, sebastian.schoppmann@meduniwien.ac.at; erwin.rieder@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achalasia specific symptoms according to the Eckardt score (0-12) (time frame: 6 mo post-op). 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 10 Aug 2015.