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

NCT ID: NCT06835374

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-11
• Study Completion Date: 2025-05-10

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. 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)

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.

Conditions

Esophageal Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Assesment of reflux esophagitis in cases with esophageal motility

Reflux esophagitis can be found in Endoscopy report.

Group Type: ACTIVE_COMPARATOR

Per oral endoscopy myotomy (Per oral endoscopy myotomy)

Intervention Type: PROCEDURE

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

Assesment of reflux esophagitis in cases without esophageal motility

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

Group Type: PLACEBO_COMPARATOR

Endoscopy procedure

Intervention Type: PROCEDURE

Endoscopy procedure is required to rule out type of reflux disease

Interventions

Per oral endoscopy myotomy (Per oral endoscopy myotomy)

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

Intervention Type: PROCEDURE

Endoscopy procedure

Endoscopy procedure is required to rule out type of reflux disease

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asian Institute of Gastroenterology, India

OTHER

Sponsor Role: lead

Responsible Party

Mohan Ramchandani

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zaheer Nabi Dr Mohammed, MBBS MD

Role: PRINCIPAL_INVESTIGATOR

AIG Hospitals

Chinmay Dr Hegde, MBBS MD

Role: PRINCIPAL_INVESTIGATOR

AIG Hospitals

Locations

Asian Institute of Gastroenterology Hospital

Hyderabad, Telangana, India

Site Status: RECRUITING

Countries

India

Central Contacts

Rajesh Goud Mr Maragoni, M.Pharm, MBA

Role: CONTACT

rajeshgoud761@gmail.com

04023378888 ext. 531

Zaheer Nabi Dr Mohammed, MBBS MD

Role: CONTACT

zaheernabi1978@gmail.com

04023378888 ext. 102

Facility Contacts

Mohan Ramchandani, MBBS

Role: primary

ramchandanimohan@gmail.com

04023378888 ext. 802

Chinmay Hegde, MBBS, MD

Role: backup

chinhegde123@gmail.com

04023378888 ext. 102

Other Identifiers

REP

Identifier Type: -

Identifier Source: org_study_id