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

NCT06835374 | Recruiting DMC

• 1 other identifier: REP
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 1.Demographic characteristics: Age, gender, type of achalasia
2. 2.Manometry findings (pre and post POEM): integrated relaxation pressure, lower esophageal sphincter pressure
3. 3.Comorbidities
4. 4.Medications
5. 5.Eckardt score: before procedure and 3-months after Procedure
6. 6.POEM procedure details: length of esophageal and gastric myotomy, adverse events, length of hospital stay
7. 7.Evaluation at 3-months Symptom: standardized questionnaire (GERDQ) Endoscopy: grade of esophagitis Erosions vs ulcers Dimension of erosions Anatomical location (according to clock)

Conditions

Esophageal Diseases

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Assesment of reflux esophagitis in cases with esophageal motility

ACTIVE COMPARATOR

Reflux esophagitis can be found in Endoscopy report.

Procedure: Per oral endoscopy myotomy (Per oral endoscopy myotomy)

Assesment of reflux esophagitis in cases without esophageal motility

PLACEBO COMPARATOR

Reflux esophagitis can be found in cases in normal gastroesophageal reflux disease condition patients

Procedure: Endoscopy procedure

Interventions

Per oral endoscopy myotomy (Per oral endoscopy myotomy) PROCEDURE

POEM is the procedure to reduce the symptoms of dysphagia, regurgitation.

Assesment of reflux esophagitis in cases with esophageal motility

Endoscopy procedure PROCEDURE

Endoscopy procedure is required to rule out type of reflux disease

Assesment of reflux esophagitis in cases without esophageal motility

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18y,
• confirmed diagnosis of Achalasia,
• No contraindication to POEM,
• erosive esophagitis on endoscopy

You may not qualify if:

• Non-esophageal esophageal motility disorders,
• Treatment other than POEM,
• current PPI use before assessment for GERD

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology Hospital

Hyderabad, Telangana, 500082, India

RECRUITING

MeSH Terms

Conditions

Esophageal Diseases

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Zaheer Nabi Dr Mohammed, MBBS MD

  AIG Hospitals

  PRINCIPAL INVESTIGATOR

• Chinmay Dr Hegde, MBBS MD

  AIG Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajesh Goud Mr Maragoni, M.Pharm, MBA

CONTACT

04023378888; rajeshgoud761@gmail.com

Zaheer Nabi Dr Mohammed, MBBS MD

CONTACT

04023378888; zaheernabi1978@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: February 19, 2025
• Study Start: May 11, 2024
• Primary Completion: February 28, 2025
• Study Completion: May 10, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)