Clinical Trial

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

Completed
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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.
Trial Details
NCT Number NCT07451301
Lead Sponsor Peking Union Medical College Hospital
Conditions Achalasia Cardia
Enrollment 195 participants
Start Date 2019-02-01
Primary Completion 2025-03-01 (estimated)
Study Completion 2025-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-05