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

Esophageal Achalasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05113173
• Other study ID #: YYYXYJ-2021-085
• Status: Recruiting
• Start date: May 11, 2021
• Est. completion date: April 16, 2024

Study information

• Verified date: June 2023
• Source: Beijing Friendship Hospital
• Contact: Fandong Meng
• Phone: +8613681061594
• Email: mfdzhaotianyu[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 16, 2024
• Est. primary completion date: April 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Achalasia

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Fandong Meng

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12months after POEM