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

Comparative Assessment of Reflux Esophagitis in Cases With and Without Esophageal Motility Disorders

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)

Study Overview

• Status: Recruiting
• Conditions: Esophageal Diseases
• Intervention / Treatment: Procedure: Per oral endoscopy myotomy (Per oral endoscopy myotomy); Procedure: Endoscopy procedure

Detailed Description

POEM will be performed using a standardized technique.8 The patients will be prescribed a single dose anti-secretory medicine (equivalent to 40 mg esomeprazole) for two months after POEM. Consecutive patients who meet the inclusion and exclusion criteria will be followed up after 3 months. PPIs will be discontinued for at least 4 weeks prior to objective evaluation of GERD. Each patient returning after 3 months for follow up will undergo several follow up examinations, including GERD questionnaire scoring, Esophagogastroduodenoscopy, 24 hour pH impedance test. Presence of endoscopically visible esophagitis . Endoscopic findings such as anatomical location, dimensions of the mucosal breaks will be compared to general population with diagnosis of GERD who have endoscopically visible esophagitis.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rajesh Goud Mr Maragoni, M.Pharm, MBA; Phone Number: 531 04023378888; Email: rajeshgoud761@gmail.com
• Study Contact Backup: Name: Zaheer Nabi Dr Mohammed, MBBS MD; Phone Number: 102 04023378888; Email: zaheernabi1978@gmail.com

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Recruiting
      • Asian Institute of Gastroenterology Hospital
      • Contact: Mohan Ramchandani, MBBS; Phone Number: 802 04023378888; Email: ramchandanimohan@gmail.com
      • Contact: Chinmay Hegde, MBBS, MD; Phone Number: 102 04023378888; Email: chinhegde123@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Assesment of reflux esophagitis in cases with esophageal motility; Reflux esophagitis can be found in Endoscopy report.	Procedure: Per oral endoscopy myotomy (Per oral endoscopy myotomy); POEM is the procedure to reduce the symptoms of dysphagia, regurgitation.
Placebo Comparator: Assesment of reflux esophagitis in cases without esophageal motility; Reflux esophagitis can be found in cases in normal gastroesophageal reflux disease condition patients	Procedure: Endoscopy procedure; Endoscopy procedure is required to rule out type of reflux disease

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Principal Investigator: Zaheer Nabi Dr Mohammed, MBBS MD, AIG Hospitals; Principal Investigator: Chinmay Dr Hegde, MBBS MD, AIG Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2024
• Primary Completion (Estimated): May 28, 2026
• Study Completion (Estimated): May 10, 2027

Study Registration Dates

• First Submitted: February 8, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): February 19, 2025

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy
• Other Study ID Numbers: REP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No