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NCT05113173

Study on the Relationship Between Pathological Features of Achalasia and Prognosis of Per-oral Endoscopic Myotomy

Status unknown Last updated 22 June 2023
What this trial tests

trial in Esophageal Achalasia in 50 participants. Status unknown.

Timeline
11 May 2021
Primary endpoint
16 April 2024
16 April 2024

Quick facts

Lead sponsorFandong Meng
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment50
Start date11 May 2021
Primary completion16 April 2024
Estimated completion16 April 2024
Sites1 location across China

Conditions studied

Sponsor

Fandong Meng

Who can join

Adults 18 to 80, any sex, with Esophageal Achalasia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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