Esophageal AchalasiaNCT05113173
Study on the Relationship Between Pathological Features of Achalasia and Prognosis of Per-oral Endoscopic Myotomy
An observational study of Esophageal Achalasia, run by Fandong Meng at 1 site in China.
Trial summary
Achalasia is the most common motility disorder of esophagus, characterized by disorders of the lower esophageal sphincter (LES). Normal peristalsis of the esophagus is eliminated and replaced by synchronous or ineffective contraction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Achalasia
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2021to 16 Apr 2024
- Phase
- Observational
- 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
Study population: Participants with achalasia are hospitalized in Beijing Friendship Hospital.
Who may be able to join
- Participants with achalasia
- Age: 18 to 80 years
- Accept for the treatment of POEM
- Sign the informed consent
Who cannot join
- Participants under 18 years old
- Previously received treatment of achalasia, Barrett's esophagus, esophageal stricture, liver cirrhosis, and/or esophageal varices, tumors, allergic diseases and hiatal hernia.
- Use non-steroidal anti-inflammatory drugs, corticosteroids and other immunosuppressive agents.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100000
Fandong Meng, Doctor, +86-10-63138650, mfdzhaotianyu@163.com
Junnan Gu
About this study
Official title: Study on the Relationship Between Different Pathological Features of Achalasia and Prognosis of Per-oral Endoscopic Myotomy
Achalasia is the most common motility disorder of esophagus, characterized by disorders of the lower esophageal sphincter (LES). Normal peristalsis of the esophagus is eliminated and replaced by synchronous or ineffective contraction. Based on high-resolution manometry (HRM), the participants with achalasia were categorized into 3 subtypes, type I: achalasia with minimum esophageal pressurization, type II: achalasia with esophageal compression and type III: achalasia with spasm.
Previous studies have found that the pathological features of the esophageal muscular layers in participants with achalasia are degeneration of nerve plexus, reduction of interstitial cells of Cajal (ICCs) and infiltration of different inflammatory cells. Different subtypes of achalasia have different pathological characteristics and esophageal motility. Now, per-oral endoscopic myotomy (POEM) is a main therapy for participants with achalasia. Most studies have focused on the relationship between pathological features and motility characteristics of achalasia, but there are few studies on the relationship between pathological features and therapeutic effect of POEM.
This study will prospectively collect data of participants undergoing POEM for achalasia in Beijing Friendship Hospital, including demographic data, drug and surgical treatment data during hospitalization. All participants are required to obtain esophageal muscle biopsy for pathological examination during POEM. The participants will be followed up until 12 months for improvement in clinical symptoms.
Read the detailed description
Achalasia is the most common motility disorder of esophagus, characterized by disorders of the lower esophageal sphincter (LES). Normal peristalsis of the esophagus is eliminated and replaced by synchronous or ineffective contraction. Based on high-resolution manometry (HRM), the participants with achalasia were categorized into 3 subtypes, type I: achalasia with minimum esophageal pressurization, type II: achalasia with esophageal compression and type III: achalasia with spasm.
Previous studies have found that the pathological features of the esophageal muscular layers in participants with achalasia are degeneration of nerve plexus, reduction of interstitial cells of Cajal (ICCs) and infiltration of different inflammatory cells. Different subtypes of achalasia have different clinical characteristics and esophageal motility. Studies have found that ganglion cells in type I participants are significantly reduced compared with type II participants, but the pattern is similar, which may indicate that type I achalasia represents the progression of type II achalasia. In addition, Achalasia is related to viral infection and autoimmune disease. Studies have shown that pathological biopsies of muscle in participants with achalasia show significantly increased rates of lymphocytes in tissues, as well as mast cells.
Now, per-oral endoscopic myotomy (POEM) is a main therapy for participants with achalasia. Most studies have focused on the relationship between pathological features and motility characteristics of achalasia, but there are few studies on the relationship between pathological features and therapeutic effect of POEM.
This study will prospectively collect data of participants undergoing POEM for achalasia in Beijing Friendship Hospital, including demographic data, drug and surgical treatment data during hospitalization. All participants are required to obtain esophageal muscle biopsy for pathological examination during POEM. The participants will be followed up until 12 months for improvement in clinical symptoms and gastroesophageal reflux after POEM.
- Conditions
- Esophageal Achalasia
- Keywords
- Esophageal Achalasia, per-oral endoscopic myotomy, pathology
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type I Achalasia | Severe loss of ganglion cells,loss of ICCs. | |
| Type II Achalasia | Loss of ICCs, mild loss of ganglion cells. | |
| Type III Achalasia | Preserved ICCs, less loss of ganglion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eckardt score
Eckardt score is used to assess the severity of symptoms in participants with achalasia. The Eckardt score evaluates weight loss, dysphagia, retrosternal pain, and reflux of achalasia. The maximum value is 12 and the minimum value is 0. Higher scores mean a worse outcome.
Measured: 12months after POEM
Secondary outcomes (1)
GERDQ score
GERDQ is a abbreviation of gastroesophageal reflux disease questionnaire. GERDQ score is used to assess the degree of gastroesophageal reflux after POEM. The maximum value is 18 and the minimum value is 0. Higher scores mean a worse outcome. Gastroesophageal reflux disease can be diagnosed if the GERDQ score is greater than or equal to 8.
Measured: 12months after POEM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start11 May 2021
- Primary completion16 Apr 2024 (estimated)
- Study completion16 Apr 2024 (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 Esophageal AchalasiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fandong Meng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fandong Meng, Beijing Friendship Hospital
- Investigators
- Fandong Meng, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113173
- Sponsor's protocol ID
- YYYXYJ-2021-085
- Status last verified
- Jun 2023
- First submitted
- 11 Oct 2021
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Investigators haven't decided which parts to share yet.
Publications
Liu ZQ, Chen WF, Wang Y, Xu XY, Zeng YG, Lee Dillon D, Cheng J, Xu MD, Zhong YS, Zhang YQ, Yao LQ, Zhou PH, Li QL. Mast cell infiltration associated with loss of interstitial cells of Cajal and neuronal degeneration in achalasia. Neurogastroenterol Motil. 2019 May;31(5):e13565. doi: 10.1111/nmo.13565. Epub 2019 Mar 13.
PubMed 30868687
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Relationship Between Different Pathological Features of Achalasia and Prognosis of Per-oral Endoscopic Myotomy
- ClinicalTrials.gov ID
- NCT05113173
- Acronym / sponsor ID
- YYYXYJ-2021-085
- Conditions
- Esophageal Achalasia
- Keywords
- Esophageal Achalasia, per-oral endoscopic myotomy, pathology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fandong MengUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 16 Apr 2024 (estimated)
- Study completion
- 16 Apr 2024 (estimated)
- First posted
- 9 Nov 2021 (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.
Achalasia is the most common motility disorder of esophagus, characterized by disorders of the lower esophageal sphincter (LES). Normal peristalsis of the esophagus is eliminated and replaced by synchronous or ineffective contraction. Based on high-resolution manometry (HRM), the participants with achalasia were categorized into 3 subtypes, type I: achalasia with minimum esophageal pressurization, type II: achalasia with esophageal compression and type III: achalasia with spasm.
Previous studies have found that the pathological features of the esophageal muscular layers in participants with achalasia are degeneration of nerve plexus, reduction of interstitial cells of Cajal (ICCs) and infiltration of different inflammatory cells. Different subtypes of achalasia have different pathological characteristics and esophageal motility. Now, per-oral endoscopic myotomy (POEM) is a main therapy for participants with achalasia. Most studies have focused on the relationship between pathological features and motility characteristics of achalasia, but there are few studies on the relationship between pathological features and therapeutic effect of POEM.
This study will prospectively collect data of participants undergoing POEM for achalasia in Beijing Friendship Hospital, including demographic data, drug and surgical treatment data during hospitalization. All participants are required to obtain esophageal muscle biopsy for pathological examination during POEM. The participants will be followed up until 12 months for improvement in clinical symptoms.
Detailed description
Achalasia is the most common motility disorder of esophagus, characterized by disorders of the lower esophageal sphincter (LES). Normal peristalsis of the esophagus is eliminated and replaced by synchronous or ineffective contraction. Based on high-resolution manometry (HRM), the participants with achalasia were categorized into 3 subtypes, type I: achalasia with minimum esophageal pressurization, type II: achalasia with esophageal compression and type III: achalasia with spasm.
Previous studies have found that the pathological features of the esophageal muscular layers in participants with achalasia are degeneration of nerve plexus, reduction of interstitial cells of Cajal (ICCs) and infiltration of different inflammatory cells. Different subtypes of achalasia have different clinical characteristics and esophageal motility. Studies have found that ganglion cells in type I participants are significantly reduced compared with type II participants, but the pattern is similar, which may indicate that type I achalasia represents the progression of type II achalasia. In addition, Achalasia is related to viral infection and autoimmune disease. Studies have shown that pathological biopsies of muscle in participants with achalasia show significantly increased rates of lymphocytes in tissues, as well as mast cells.
Now, per-oral endoscopic myotomy (POEM) is a main therapy for participants with achalasia. Most studies have focused on the relationship between pathological features and motility characteristics of achalasia, but there are few studies on the relationship between pathological features and therapeutic effect of POEM.
This study will prospectively collect data of participants undergoing POEM for achalasia in Beijing Friendship Hospital, including demographic data, drug and surgical treatment data during hospitalization. All participants are required to obtain esophageal muscle biopsy for pathological examination during POEM. The participants will be followed up until 12 months for improvement in clinical symptoms and gastroesophageal reflux after POEM.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type I Achalasia | – | –Severe loss of ganglion cells,loss of ICCs. |
| Type II Achalasia | – | –Loss of ICCs, mild loss of ganglion cells. |
| Type III Achalasia | – | –Preserved ICCs, less loss of ganglion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with achalasia are hospitalized in Beijing Friendship Hospital.
Key inclusion criteria (4 listed)
- Participants with achalasia
- Age: 18 to 80 years
- Accept for the treatment of POEM
- Sign the informed consent
Key exclusion criteria (3 listed)
- Participants under 18 years old
- Previously received treatment of achalasia, Barrett's esophagus, esophageal stricture, liver cirrhosis, and/or esophageal varices, tumors, allergic diseases and hiatal hernia.
- Use non-steroidal anti-inflammatory drugs, corticosteroids and other immunosuppressive agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Eckardt score
Time frame: 12months after POEM
Eckardt score is used to assess the severity of symptoms in participants with achalasia. The Eckardt score evaluates weight loss, dysphagia, retrosternal pain, and reflux of achalasia. The maximum value is 12 and the minimum value is 0. Higher scores mean a worse outcome.
1 secondary outcome
GERDQ score
Time frame: 12months after POEM
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Background: PubMed 30868687Liu ZQ, Chen WF, Wang Y, Xu XY, Zeng YG, Lee Dillon D, Cheng J, Xu MD, Zhong YS, Zhang YQ, Yao LQ, Zhou PH, Li QL. Mast cell infiltration associated with loss of interstitial cells of Cajal and neuronal degeneration in achalasia. Neurogastroenterol Motil. 2019 May;31(5):e13565. doi: 10.1111/nmo.13565. Epub 2019 Mar 13.
- Individual participant dataSharing planned: Undecided. Investigators haven't decided which parts to share yet.
Related trials for Esophageal Achalasia
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Full-thickness Versus Progressive Myotomy in Peroral Endoscopic Esophageal Myotomy in Achalasia: A Randomized Controlled Trial
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PREcision MEDicine In Achalasia (PREMEDIA)
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PREcision MEDicine In Achalasia (PREMEDIA) - Cohort
Type III Achalasia, EGJ Outflow Obstruction With Spastic/Hypercontractile Features
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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.
Fandong Meng principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Achalasia, run by Fandong Meng at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. 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 China. 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 Fandong Meng (+8613681061594, mfdzhaotianyu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eckardt score (time frame: 12months after POEM). 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 NCT05113173, 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 22 Jun 2023.