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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-11

Study Completion Date

2024-04-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Endoscopic Peroral Myotomy for Treatment of Achalasia

NCT01405417

Achalasia

TERMINATED NA

Comparative Assessment of Esophagitis in Cases With and Without Esophageal Motility Disorders: A Prospective Study

NCT06835374

Esophageal Diseases

RECRUITING NA

Esophageal Motility Disorders in Patients With Non-cardiac Chest Pain at Assiut University Hospital

NCT05402462

Esophageal Motility Disorders

UNKNOWN

Clinical Outcomes of Peroral Endoscopic Myotomy

NCT02989883

Achalasia

UNKNOWN NA

COMPREHENSIVE ANALYSIS OF NUTRITIONAL PARAMETERS IN PATIENTS WITH IDIOPATHIC ACHALASIA: A PROSPECTIVE STUDY.

NCT05161923

Weight Gain Nutritional Imbalance

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Achalasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Type I Achalasia

Severe loss of ganglion cells,loss of ICCs.

No interventions assigned to this group

Type II Achalasia

Loss of ICCs, mild loss of ganglion cells.

No interventions assigned to this group

Type III Achalasia

Preserved ICCs, less loss of ganglion.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No