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

NCT06835374 · tracked via the Priya Life Science India tracker

Sponsor

Asian Institute of Gastroenterology, India

Phase

Not applicable

Started

2024-05-11

Last updated

2026-06-03

Condition(s) studied

Esophageal Diseases

Investigational drug(s) / intervention(s)

Per oral endoscopy myotomy (Per oral endoscopy myotomy)Endoscopy procedure

Per oral endoscopy myotomy (Per oral endoscopy myotomy): POEM is the procedure to reduce the symptoms of dysphagia, regurgitation.

Endoscopy procedure: Endoscopy procedure is required to rule out type of reflux disease

Study 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)

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Age≥18y, 2. confirmed diagnosis of Achalasia, 3. No contraindication to POEM, 4. erosive esophagitis on endoscopy Exclusion Criteria: 1. Non-esophageal esophageal motility disorders, 2. Treatment other than POEM, 3. current PPI use before assessment for GERD

Primary outcome measure(s)

comparison of reflux esophagitis in cases who undergo POEM procedure versus those without esophageal motility disorders — 3 months
Reflux esophagitis can be calculated as grade B category (red colour scar found in esophagus mucosa) during endoscopy procedure
Assessment of the , esophageal acid exposure — 6 months
esophageal acid exposure is a value indicates higher reflux can be calculated in ph impedence report

Trial sites (1)

Facility	City	Region	Status
Asian Institute of Gastroenterology Hospital	Hyderabad	Telangana	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06835374 on ClinicalTrials.gov ↗ ← All trials in India