NCT07451301

Serum Anti-enteric Neuronal Antibodies in Patients With Achalasia and Their Association With Clinical Profiles

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 195 (actual)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

Achalasia is a rare esophageal motility disorder characterized by impaired relaxation of the lower esophageal sphincter and progressive esophageal dilation. Increasing evidence suggests that autoimmune mechanisms may contribute to its development. Serum anti-enteric neuronal antibodies (AENA) have been reported more frequently in patients with achalasia than in healthy individuals. This study aims to evaluate the association between AENA levels and disease severity in patients with achalasia. Specifically, it aims to determine whether the intensity of AENA positivity is associated with endoscopic severity (measured by the CARS score), esophageal dilation, and integrated relaxation pressure. The study also aims to assess whether AENA status is associated with symptomatic outcomes following peroral endoscopic myotomy (POEM). The objective is to determine whether AENA may serve as a potential biomarker for identifying patients with a more severe disease phenotype and less favorable treatment response.

Conditions

• Achalasia Cardia

Interventions

Type	Name	Description
PROCEDURE	peroral endoscopic myotomy (POEM)	A subset of eligible patients subsequently underwent POEM at our institution using the standardized technique described by Inoue et al. Postoperative follow-up assessments were conducted at 1, 3, and 6 months and included evaluation of Eckardt scores. At the 6-month follow-up, repeat esophagogastroduodenoscopy (with grading of erosive esophagitis according to the Los Angeles classification esophagitis), HRM, and barium esophagogram were performed.

Timeline

• Start date: 2019-02-01
• Primary completion: 2025-03-01
• Completion: 2025-11-01
• First posted: 2026-03-05
• Last updated: 2026-03-05

Locations

1 site across 1 country: China