Clinical Trial

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

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Summary
Achalasia is a neuro-degenerative disorder marked by changes in the peristalsis of the esophagus and the lack of relaxation in the lower esophageal sphincter (LES), thought to be due to damage to the myenteric plexus with an unknown cause.1 Per-oral endoscopic myotomy (POEM) is an established endoscopic treatment modality for achalasia. Leading gastrointestinal (GI) societies endorse POEM as one of the primary treatment option for achalasia.This study aims to characterize and compare the morphological characteristics of reflux related erosions after the POEM procedures versus those in cases without esophageal motility disorders. Data collection 1. Demographic characteristics: Age, gender, type of achalasia 2. Manometry findings (pre and post POEM): integrated relaxation pressure, lower esophageal sphincter pressure 3. Comorbidities 4. Medications 5. Eckardt score: before procedure and 3-months after Procedure 6. POEM procedure details: length of esophageal and gastric myotomy, adverse events, length of hospital stay 7. Evaluation at 3-months Symptom: standardized questionnaire (GERDQ) Endoscopy: grade of esophagitis Erosions vs ulcers Dimension of erosions Anatomical location (according to clock)
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-02-13.
Trial Details
NCT Number NCT06835374
Lead Sponsor Asian Institute of Gastroenterology, India
Conditions Esophageal Diseases
Enrollment 200 participants
Start Date 2024-05-11
Primary Completion 2026-05-28 (estimated)
Study Completion 2027-05-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-03