Study on the Relationship Between Pathological Features of Achalasia and Prognosis of Per-oral Endoscopic Myotomy
1 other identifier
observational
50
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 11, 2021
CompletedFirst Submitted
Initial submission to the registry
October 11, 2021
CompletedFirst Posted
Study publicly available on registry
November 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 16, 2024
CompletedJune 22, 2023
June 1, 2023
2.9 years
October 11, 2021
June 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12months after POEM
Secondary Outcomes (1)
GERDQ score
12months after POEM
Study Arms (3)
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.
Eligibility Criteria
Participants with achalasia are hospitalized in Beijing Friendship Hospital.
You may qualify if:
- Participants with achalasia
- Age: 18 to 80 years
- Accept for the treatment of POEM
- Sign the informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fandong Menglead
Study Sites (1)
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100000, China
Related Publications (1)
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.
PMID: 30868687BACKGROUND
Biospecimen
esophageal muscular layers
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fandong Meng
Beijing Friendship Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- chief physician
Study Record Dates
First Submitted
October 11, 2021
First Posted
November 9, 2021
Study Start
May 11, 2021
Primary Completion
April 16, 2024
Study Completion
April 16, 2024
Last Updated
June 22, 2023
Record last verified: 2023-06