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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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)

More Asian Institute of Gastroenterology, India trials in India

Other trials for the same condition