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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAsian Institute of Gastroenterology, India

About this trial

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 criteria

Qualifiers

Age≥18y,

confirmed diagnosis of Achalasia,

No contraindication to POEM,

erosive esophagitis on endoscopy

Disqualifiers

Non-esophageal esophageal motility disorders,

Treatment other than POEM,

current PPI use before assessment for GERD

Trial design

Treatments tested in this trial

  • Per oral endoscopy myotomy (Per oral endoscopy myotomy)
  • Endoscopy procedure

Treatment groups

200 Participants
are divided into 2 treatment groups