AchalasiaPOEMNCT02482337
Per-Oral Endoscopic Myotomy for Esophageal Swallowing Disorders
A study testing POEM in people with Achalasia, run by Baylor Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to show that the Per-Oral Endoscopic Myotomy (POEM) procedure is an effective treatment for people with achalasia. Read more about this study
- Who is it for?
- Ages 18 to 85 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
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Oct 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with symptomatic achalasia or EGJ outflow obstruction with a motility study, esophagram, and EGD consistent with EGJ outflow obstruction.
- Medical indication for surgical myotomy.
- Ability to undergo general anesthesia
- Age > 18 yrs. of age and <85 yrs. of age with ability to give informed consent
- Candidate for laparoscopic esophageal myotomy.
Who cannot join
- Previous chest radiotherapy.
- Eosinophilic esophagitis
- Barrett's esophagus
- Stricture of esophagus
- Malignant or premalignant esophageal lesion
- Contraindications for EGD.
- Unable to provide informed consent.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
Official title: Prospective Evaluation of Per-Oral Endoscopic Myotomy (POEM) of the Lower Esophageal Sphincter for the Treatment of Esophageal Swallowing Disorders
The purpose of this study is to show that the Per-Oral Endoscopic Myotomy (POEM) procedure is an effective treatment for people with achalasia.
Read the detailed description
Currently the most commonly performed definitive treatment for symptomatic esophago-gastric junction outflow obstruction is a laparoscopic esophageal myotomy (LEM). In this procedure the outer longitudinal and inner circular muscle fibers of the distal esophagus and proximal stomach are divided, releasing the spasm and resulting in an open lumen. Although this procedure is effective in relieving troubles swallowing and in improving esophageal emptying, it is often accompanied by the development of GERD (as the muscle division results in incompetence of the antireflux barrier, the lower esophageal sphincter). For this reason a laparoscopic esophageal myotomy is most often accompanied by a fundoplication, in which part of the fundus of the stomach is folded around the distal esophagus and sutured in place, recreating a flap-valve mechanism. (It is best to perform this at the time of the laparoscopic myotomy as reoperation in that area is difficult). The fundoplication however may be imperfect, and may result in some degree of outflow obstruction itself or fail to control reflux. LEM results in 80% to 90% global patient satisfaction; but 10-20% continue to experience moderate dysphagia and 10-35% will have GERD by esophageal pH testing.
Others have evaluated the possibility of surgically dividing the muscle fibers from within the esophagus, using an endoscope rather than a laparoscope, in an animal model. The first human experience was reported in Japan using a per-oral endoscope to (a) incise the mucosa in the proximal esophagus as an entry point, (b) create a submucosal tunnel downwards, (c) perform an esophageal myotomy of the distal esophageal circular muscle, and (d) close the mucosal entry site with clips. The creation of the submucosal tunnel for some distance before the myotomy is a safety measure, so that should the mucosal closure fail, native tissues will appose and help seal any leak (rather like the Z-entry for a thoracentesis). Subsequent to this initial report, multiple single-arm studies have reported that the technique is safe and is associated with excellent medium-term relief of dysphagia..
In the POEM technique no fundoplication is performed. By the endoscopic creation of an esophageal submucosal tunnel the inner circular muscle layer could be easily visualized and in contrast to conventional laparoscopic esophageal myotomy, the authors described the division of only this inner circular esophageal muscle layer leaving the outer longitudinal muscle layer intact. The distal esophagus is exposed in LEM, hence disrupting the attachments to the diaphragm. These attachments contribute to the overall antireflux mechanism. It is hypothesized that by only dividing the inner circular muscle, and not disrupting the contribution of the outer longitudinal muscle or the diaphragmatic attachments to the antireflux mechanism, POEM may not have the same potential for reflux as a LEM. If this is the case then an antireflux procedure may not be needed after the POEM procedure.
- 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
POEM procedure in the OR
| Study group | Role | What they receive |
|---|---|---|
| POEM procedure | Experimental | Patients who underwent POEM Receives: Procedure: POEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in swallowing
Outcome measure will be assessed by a questionnaire based on the patient's ability to swallow, by radiographic study, upper gastrointestinal endoscopy and ambulatory reflux testing.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startJun 2014
- Primary completionOct 2024
- Study completionOct 2024
Why it stopped: The study was terminated by the Principal Investigator's to redesign it using more efficient processes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Leeds, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482337
- Sponsor's protocol ID
- 014-103
- Acronym
- POEM
- Status last verified
- Mar 2025
- First submitted
- 7 May 2015
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pescarus R, Shlomovitz E, Swanstrom LL. Per-oral endoscopic myotomy (POEM) for esophageal achalasia. Curr Gastroenterol Rep. 2014 Jan;16(1):369. doi: 10.1007/s11894-013-0369-6.
PubMed 24362953Pasricha PJ, Hawari R, Ahmed I, Chen J, Cotton PB, Hawes RH, Kalloo AN, Kantsevoy SV, Gostout CJ. Submucosal endoscopic esophageal myotomy: a novel experimental approach for the treatment of achalasia. Endoscopy. 2007 Sep;39(9):761-4. doi: 10.1055/s-2007-966764.
PubMed 17703382Inoue H, Minami H, Satodate H, Kudo S. First clinical experience of submucosal endoscopic esophageal myotomy for esophageal achalasia with no skin incision. Gastrointestinal Endoscopy 69(5): AB122, 2009.
Luketich JD, Fernando HC, Christie NA, Buenaventura PO, Keenan RJ, Ikramuddin S, Schauer PR. Outcomes after minimally invasive esophagomyotomy. Ann Thorac Surg. 2001 Dec;72(6):1909-12; discussion 1912-3. doi: 10.1016/s0003-4975(01)03127-7.
PubMed 11789770
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Per-Oral Endoscopic Myotomy (POEM) of the Lower Esophageal Sphincter for the Treatment of Esophageal Swallowing Disorders
- ClinicalTrials.gov ID
- NCT02482337
- Acronym / sponsor ID
- POEM / 014-103
- Conditions
- Achalasia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated by the Principal Investigator's to redesign it using more efficient processes.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Oct 2024 (actual)
- Study completion
- Oct 2024 (actual)
- First posted
- 26 Jun 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.
The purpose of this study is to show that the Per-Oral Endoscopic Myotomy (POEM) procedure is an effective treatment for people with achalasia.
Detailed description
Currently the most commonly performed definitive treatment for symptomatic esophago-gastric junction outflow obstruction is a laparoscopic esophageal myotomy (LEM). In this procedure the outer longitudinal and inner circular muscle fibers of the distal esophagus and proximal stomach are divided, releasing the spasm and resulting in an open lumen. Although this procedure is effective in relieving troubles swallowing and in improving esophageal emptying, it is often accompanied by the development of GERD (as the muscle division results in incompetence of the antireflux barrier, the lower esophageal sphincter). For this reason a laparoscopic esophageal myotomy is most often accompanied by a fundoplication, in which part of the fundus of the stomach is folded around the distal esophagus and sutured in place, recreating a flap-valve mechanism. (It is best to perform this at the time of the laparoscopic myotomy as reoperation in that area is difficult). The fundoplication however may be imperfect, and may result in some degree of outflow obstruction itself or fail to control reflux. LEM results in 80% to 90% global patient satisfaction; but 10-20% continue to experience moderate dysphagia and 10-35% will have GERD by esophageal pH testing.
Others have evaluated the possibility of surgically dividing the muscle fibers from within the esophagus, using an endoscope rather than a laparoscope, in an animal model. The first human experience was reported in Japan using a per-oral endoscope to (a) incise the mucosa in the proximal esophagus as an entry point, (b) create a submucosal tunnel downwards, (c) perform an esophageal myotomy of the distal esophageal circular muscle, and (d) close the mucosal entry site with clips. The creation of the submucosal tunnel for some distance before the myotomy is a safety measure, so that should the mucosal closure fail, native tissues will appose and help seal any leak (rather like the Z-entry for a thoracentesis). Subsequent to this initial report, multiple single-arm studies have reported that the technique is safe and is associated with excellent medium-term relief of dysphagia..
In the POEM technique no fundoplication is performed. By the endoscopic creation of an esophageal submucosal tunnel the inner circular muscle layer could be easily visualized and in contrast to conventional laparoscopic esophageal myotomy, the authors described the division of only this inner circular esophageal muscle layer leaving the outer longitudinal muscle layer intact. The distal esophagus is exposed in LEM, hence disrupting the attachments to the diaphragm. These attachments contribute to the overall antireflux mechanism. It is hypothesized that by only dividing the inner circular muscle, and not disrupting the contribution of the outer longitudinal muscle or the diaphragmatic attachments to the antireflux mechanism, POEM may not have the same potential for reflux as a LEM. If this is the case then an antireflux procedure may not be needed after the POEM procedure.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POEM procedure | Experimental | Procedure: POEMPatients who underwent POEM |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with symptomatic achalasia or EGJ outflow obstruction with a motility study, esophagram, and EGD consistent with EGJ outflow obstruction.
- Medical indication for surgical myotomy.
- Ability to undergo general anesthesia
- Age > 18 yrs. of age and <85 yrs. of age with ability to give informed consent
- Candidate for laparoscopic esophageal myotomy.
Key exclusion criteria (8 listed)
- Previous chest radiotherapy.
- Eosinophilic esophagitis
- Barrett's esophagus
- Stricture of esophagus
- Malignant or premalignant esophageal lesion
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 |
|---|---|---|
| POEMPOEM procedure in the OR | Procedure or surgery | POEM procedure |
Primary outcome
Improvement in swallowing
Time frame: 6 months after surgery
Outcome measure will be assessed by a questionnaire based on the patient's ability to swallow, by radiographic study, upper gastrointestinal endoscopy and ambulatory reflux testing.
Results and safety
The study was stopped early (reason given: The study was terminated by the Principal Investigator's to redesign it using more efficient processes.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Background: PubMed 24362953Pescarus R, Shlomovitz E, Swanstrom LL. Per-oral endoscopic myotomy (POEM) for esophageal achalasia. Curr Gastroenterol Rep. 2014 Jan;16(1):369. doi: 10.1007/s11894-013-0369-6.
- Background: PubMed 17703382Pasricha PJ, Hawari R, Ahmed I, Chen J, Cotton PB, Hawes RH, Kalloo AN, Kantsevoy SV, Gostout CJ. Submucosal endoscopic esophageal myotomy: a novel experimental approach for the treatment of achalasia. Endoscopy. 2007 Sep;39(9):761-4. doi: 10.1055/s-2007-966764.
- BackgroundInoue H, Minami H, Satodate H, Kudo S. First clinical experience of submucosal endoscopic esophageal myotomy for esophageal achalasia with no skin incision. Gastrointestinal Endoscopy 69(5): AB122, 2009.
- Background: PubMed 11789770Luketich JD, Fernando HC, Christie NA, Buenaventura PO, Keenan RJ, Ikramuddin S, Schauer PR. Outcomes after minimally invasive esophagomyotomy. Ann Thorac Surg. 2001 Dec;72(6):1909-12; discussion 1912-3. doi: 10.1016/s0003-4975(01)03127-7.
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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.
Steven Leeds, MD principal investigator
Baylor Health Care System
1 site 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 Baylor Research Institute 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 20 Mar 2025. 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 was stopped early (reason given: The study was terminated by the Principal Investigator's to redesign it using more efficient processes.). Results are not available in the source record.
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?
Improvement in swallowing (time frame: 6 months after surgery). 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 NCT02482337, which also lists 4 linked publications.
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 Mar 2025.