AchalasiaPOEMNCT04180241
Development of Endoscopic Treatment for Achalasia
A study testing POEM in people with Achalasia, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
Per Oral Endoscopic Myotomy (POEM); comparison of two surgical techniques division all the esophageal muscle layers versus division the inner circular muscle layer of the esophagus only. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Achalasia
- What is being tested?
- POEM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesSweden
- Study dates
- 15 Apr 2019to 15 Sep 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed achalasia
- the patient should understand the nature and the purpose of the study and give informed consent
Who cannot join
- previous surgical treatment of achalasia
- inability to understand the contents of or follow the protocol
- other pathology as an explanation for the obstruction of the esophageal transition
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Karolinska Institutet, Ersta Hospital
Stockholm, Region Stockholm, SE-116 91
Karolinska Institutet
Stockholm, Stockholm County Council, 116 91
About this study
Official title: Development of Endoscopic Treatment for Achalasia, POEM (Per Oral Esophageal Myotomy): A Randomized Controlled Trial
Per Oral Endoscopic Myotomy (POEM); comparison of two surgical techniques division all the esophageal muscle layers versus division the inner circular muscle layer of the esophagus only.
Read the detailed description
Prior to surgery, all patients undergo upper endoscopy , x-ray "time barium" manometry, 24 hours pH registration. Moreover Quality of Life instrument (RAND-36), GSRS (Gastrointestinal Symptom Rating Scale) and a dysphagia score (Eckardt score) are completed by all patients.
Follow-up with surveys 3, 6, 12, and 36 months (GSRS, RAND-36 and Eckardt score).
At 3,12 and 36 months an x-ray "time barium" is performed and after 12 months a gastroscopy and at 24 hours esophageal pH monitoring are performed.
- Conditions
- Achalasia
- Being tested
- POEM
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POEMProcedure or surgery
Peroral endoscopic myotomy
| Study group | Role | What they receive |
|---|---|---|
| total division of the muscle layer | Active comparator | POEM- total division of the circular muscle layer into the gastroesophageal junction Receives: Procedure: POEM |
| partial division of the muscle layer | Active comparator | POEM - partial division of the circular muscle layer into the gastroesophageal junction Receives: Procedure: POEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who develop gastroesophageal reflux disease (GERD)
Measured as esophageal acid exposure (pH <4) > 4% of recorded time
Measured: 1 year
Secondary outcomes (5)
Esophageal emptying function
Measured by Time Barium Swallow X-ray
Measured: 1 year
Eckardt score
The Eckardt score consists of 4 components including dysphagia, chest pain, regurgitation, and weight loss.Each component is assigned a score from 0 to 3 based on the patient's self-reported response, resulting in a total score that can vary from 0 to 12, higher scores mean a worse outcome.
Measured: 1 year
RAND-36
The RAND-36 It is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. Physical and mental health summary scores are also derived from the eight RAND-36 scales. higher scores mean a better outcome.
Measured: 1 year
Dysmotility
measured by Manometry
Measured: 1 year
Gastrointestinal Symptom Rating Scale (GSRS)
Scoring;The questionnaire, which contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one.
A mean value for the items in each dimension should be calculated:
Diarrhoea syndrome: 11. Increased passage of stools 12. Loose stools 14. Urgent need for defecation Indigestion syndrome: 6. Borborygmus 7. Abdominal distension 8. Eructation 9. Increased flatus Constipation syndrome: 10. Decreased passage of stools 13. Hard stools 15. Feeling of incomplete evacuation Abdominal pain syndrome: 1. Abdominal pain 4. Sucking sensations 5. Nausea and vomiting Reflux syndrome: 2. Heartburn 3. Acid regurgitation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start15 Apr 2019
- Primary completion15 Jan 2024
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Model description
- POEM with division all the esophageal muscle layers compared to deviding only the inner circular muscle layer of the esophagus.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Thorell, Karolinska Institutet
- Investigators
- Anders Thorell, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180241
- Sponsor's protocol ID
- 2017/1630-31
- Acronym
- POEM
- Status last verified
- Oct 2026
- First submitted
- 7 Nov 2019
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Endoscopic Treatment for Achalasia, POEM (Per Oral Esophageal Myotomy): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04180241
- Acronym / sponsor ID
- POEM / 2017/1630-31
- Conditions
- Achalasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 27 Nov 2019 (actual)
- 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.
Per Oral Endoscopic Myotomy (POEM); comparison of two surgical techniques division all the esophageal muscle layers versus division the inner circular muscle layer of the esophagus only.
Detailed description
Prior to surgery, all patients undergo upper endoscopy , x-ray "time barium" manometry, 24 hours pH registration. Moreover Quality of Life instrument (RAND-36), GSRS (Gastrointestinal Symptom Rating Scale) and a dysphagia score (Eckardt score) are completed by all patients.
Follow-up with surveys 3, 6, 12, and 36 months (GSRS, RAND-36 and Eckardt score).
At 3,12 and 36 months an x-ray "time barium" is performed and after 12 months a gastroscopy and at 24 hours esophageal pH monitoring are performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- POEM with division all the esophageal muscle layers compared to deviding only the inner circular muscle layer of the esophagus.
| Arm | Type | Receives |
|---|---|---|
| total division of the muscle layer | Active comparator | Procedure: POEMPOEM- total division of the circular muscle layer into the gastroesophageal junction |
| partial division of the muscle layer | Active comparator | Procedure: POEMPOEM - partial division of the circular muscle layer into the gastroesophageal junction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosed achalasia
- the patient should understand the nature and the purpose of the study and give informed consent
Key exclusion criteria (3 listed)
- previous surgical treatment of achalasia
- inability to understand the contents of or follow the protocol
- other pathology as an explanation for the obstruction of the esophageal transition
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 |
|---|---|---|
| POEMPeroral endoscopic myotomy | Procedure or surgery | partial division of the muscle layer, total division of the muscle layer |
Primary outcome
The proportion of patients who develop gastroesophageal reflux disease (GERD)
Time frame: 1 year
Measured as esophageal acid exposure (pH <4) > 4% of recorded time
5 secondary outcomes
Esophageal emptying function
Time frame: 1 year
Eckardt score
Time frame: 1 year
RAND-36
Time frame: 1 year
Dysmotility
Time frame: 1 year
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: 1 year
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 20 Oct 2026.
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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.
Anders Thorell, Professor principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POEM in people with Achalasia, run by Karolinska Institutet at 2 sites 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 2 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 20 Oct 2026. 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 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?
The proportion of patients who develop gastroesophageal reflux disease (GERD) (time frame: 1 year). 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 20 Oct 2026.