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

Recruiting

• Conditions: Esophageal Achalasia

• Registration Number: NCT05113173
• Lead Sponsor: Fandong Meng

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.

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 Timeline

• Study Start: 2021-05-11
• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-11-09
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-18
• Last Update Posted: 2023-06-22
• Primary Completion: 2024-04-16
• Study Completion: 2024-04-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Participants with achalasia
• Age: 18 to 80 years
• Accept for the treatment of POEM
• Sign the informed consent

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Eckardt score	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.

Secondary Outcome Measures

Name	Time	Method
GERDQ score	12months after POEM	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.

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China