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NCT Number: NCT06835374

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

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)

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Key information

Conditions

Esophageal Diseases Digestive System Diseases Gastrointestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Per oral endoscopy myotomy (Per oral endoscopy myotomy)

Procedure

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

Endoscopy procedure

Procedure

Endoscopy procedure is required to rule out type of reflux disease

Primary outcomes

  1. comparison of reflux esophagitis in cases who undergo POEM procedure versus those without esophageal motility disorders

    Time frame: 3 months

    Reflux esophagitis can be calculated as grade B category (red colour scar found in esophagus mucosa) during endoscopy procedure

  2. Assessment of the , esophageal acid exposure

    Time frame: 6 months

    esophageal acid exposure is a value indicates higher reflux can be calculated in ph impedence report

Study contacts

Contact information is provided by the study sponsor or research team.

Rajesh Goud Mr Maragoni, M.Pharm, MBA

CONTACT

[email protected]

04023378888 ext. 531

Zaheer Nabi Dr Mohammed, MBBS MD

CONTACT

[email protected]

04023378888 ext. 102

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 19, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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