AchalasiaNCT02989883
Clinical Outcomes of Peroral Endoscopic Myotomy
A study testing peroral endoscopic myotomy in people with Achalasia, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Esophageal outflow obstruction is characterized by failure to relax the lower esophageal sphincter (LES), resulting in impaired flow of ingested food into the stomach. The subsequent stasis of ingested food leads to symptoms of dysphagia, regurgitation, chest pain, and weight loss. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Achalasia
- What is being tested?
- peroral endoscopic myotomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2016to Sep 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were diagnosed as esophageal outflow obstruction
- Patients with informed consent
Who cannot join
- Diagnostic uncertainty
- Patients who are not suitable for general anesthesia
Trial locations and contacts
1 site in 1 country.
Hwoon-Yong Jung contact
South Korea1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center
Seoul
Hwoon-Yong Jung, M.D., PhD., hyjung@amc.seoul.kr
Hwoon-Yong Jung, M.D., PhD.
About this study
Official title: Clinical Outcomes of Peroral Endoscopic Myotomy for Esophageal Outflow Obstruction
Esophageal outflow obstruction is characterized by failure to relax the lower esophageal sphincter (LES), resulting in impaired flow of ingested food into the stomach. The subsequent stasis of ingested food leads to symptoms of dysphagia, regurgitation, chest pain, and weight loss. The core objective of the treatment of esophageal outflow obstruction is to disrupt the LES and reduce its pressure to allow esophageal emptying. Therapeutic options include pharmacologic therapy, Botulinum toxin injection, pneumatic balloon dilation, and surgical myotomy with partial fundoplication. In addition, peroral endoscopy myotomy (POEM) has recently been introduced as a minimally invasive treatment, but there have a few studies regarding long-term outcomes. The aim of this study is to evaluate clinical outcomes of POEM for esophageal outflow obstruction.
Read the detailed description
Prospective study
- Conditions
- Achalasia
- Being tested
- peroral endoscopic myotomy
- Keywords
- achalasia, POEM, outcome
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peroral endoscopic myotomyOther
The procedure consists of four steps: 1) mucosal incision 10-15 cm above the esophagogastric junction to allow entry into the submucosa, 2) creation of a submucosal tunnel until the lower esophageal sphincter is reached, 3) myotomy of the circular muscle layer, and 4) closure of the mucosal entry with endoclips.
| Study group | Role | What they receive |
|---|---|---|
| Peroral endoscopic myotomy (POEM) | Other | Patients who received POEM Receives: Other: peroral endoscopic myotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with Eckardt score <3 after the procedure
Measured: 1 month after the procedure
Secondary outcomes (1)
adverse events which are related to the procedure
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2018 (estimated)
- Study completionSep 2018 (estimated)
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 Asan Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hwoon-Yong Jung, Asan Medical Center
- Investigators
- Hwoon-Yong Jung, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989883
- Sponsor's protocol ID
- 2016-0999
- Status last verified
- Dec 2016
- First submitted
- 4 Dec 2016
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Gong EJ, Na HK, Ahn JY, Jung KW, Kim DH, Choi KD, Song HJ, Jung HY. Prospective evaluation of the efficacy of peroral endoscopic myotomy in patients with achalasia. Medicine (Baltimore). 2021 Jun 11;100(23):e26248. doi: 10.1097/MD.0000000000026248.
PubMed 34115014
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Peroral Endoscopic Myotomy for Esophageal Outflow Obstruction
- ClinicalTrials.gov ID
- NCT02989883
- Acronym / sponsor ID
- 2016-0999
- Conditions
- Achalasia
- Keywords
- achalasia, POEM, outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 12 Dec 2016 (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.
Esophageal outflow obstruction is characterized by failure to relax the lower esophageal sphincter (LES), resulting in impaired flow of ingested food into the stomach. The subsequent stasis of ingested food leads to symptoms of dysphagia, regurgitation, chest pain, and weight loss. The core objective of the treatment of esophageal outflow obstruction is to disrupt the LES and reduce its pressure to allow esophageal emptying. Therapeutic options include pharmacologic therapy, Botulinum toxin injection, pneumatic balloon dilation, and surgical myotomy with partial fundoplication. In addition, peroral endoscopy myotomy (POEM) has recently been introduced as a minimally invasive treatment, but there have a few studies regarding long-term outcomes. The aim of this study is to evaluate clinical outcomes of POEM for esophageal outflow obstruction.
Detailed description
Prospective study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peroral endoscopic myotomy (POEM) | Other | Other: peroral endoscopic myotomyPatients who received POEM |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who were diagnosed as esophageal outflow obstruction
- Patients with informed consent
Key exclusion criteria (2 listed)
- Diagnostic uncertainty
- Patients who are not suitable for general anesthesia
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 |
|---|---|---|
| peroral endoscopic myotomyThe procedure consists of four steps: 1) mucosal incision 10-15 cm above the esophagogastric junction to allow entry into the submucosa, 2) creation of a submucosal tunnel until the lower esophageal sphincter is reached, 3) myotomy of the circular muscle layer, and 4) closure of the mucosal entry with endoclips. | Other | Peroral endoscopic myotomy (POEM) |
Primary outcome
number of patients with Eckardt score <3 after the procedure
Time frame: 1 month after the procedure
1 secondary outcome
adverse events which are related to the procedure
Time frame: within 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Derived from this study: PubMed 34115014Gong EJ, Na HK, Ahn JY, Jung KW, Kim DH, Choi KD, Song HJ, Jung HY. Prospective evaluation of the efficacy of peroral endoscopic myotomy in patients with achalasia. Medicine (Baltimore). 2021 Jun 11;100(23):e26248. doi: 10.1097/MD.0000000000026248.
- Individual participant dataSharing planned: No
Related trials for Achalasia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Full-thickness Versus Progressive Myotomy in Peroral Endoscopic Esophageal Myotomy in Achalasia: A Randomized Controlled Trial
Achalasia Cardia, Achalasia
RecruitingPhase 3
PREcision MEDicine In Achalasia (PREMEDIA)
Type I Achalasia, Type II Achalasia
RecruitingObservational study
PREcision MEDicine In Achalasia (PREMEDIA) - Cohort
Type III Achalasia, EGJ Outflow Obstruction With Spastic/Hypercontractile Features
RecruitingPhase 4
VZV in the Enteric Nervous System: Pathogenesis and Consequences
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.
Hwoon-Yong Jung contact
Hwoon-Yong Jung principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peroral endoscopic myotomy in people with Achalasia, run by Asan Medical Center at 1 site in South Korea.
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 2 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: status not confirmed, as of the sponsor's last update on 12 Dec 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hwoon-Yong Jung (hyjung@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with Eckardt score <3 after the procedure (time frame: 1 month after the procedure). 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 NCT02989883, 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 12 Dec 2016.