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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Per oral endoscopy myotomy (Per oral endoscopy myotomy)

    Procedure/Surgery

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

  • Endoscopy procedure

    Procedure/Surgery

    Endoscopy procedure is required to rule out type of reflux disease

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Assesment of reflux esophagitis in cases with esophageal motilityActive comparator 1 intervention
Group B: Assesment of reflux esophagitis in cases without esophageal motilityPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
3 months
2

Assessment of the , esophageal acid exposure

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

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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