Comparative Assessment of Esophagitis in Cases With and Without Esophageal Motility Disorders: A Prospective Study
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Per oral endoscopy myotomy (Per oral endoscopy myotomy), Endoscopy procedure.
- Who it may be relevant to
- Registry conditions: Esophageal Diseases. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Assessment of Reflux Esophagitis in Cases With and Without Esophageal Motility Disorders
Overview
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.
Interventions
- Procedure Per oral endoscopy myotomy (Per oral endoscopy myotomy)
POEM is the procedure to reduce the symptoms of dysphagia, regurgitation. - Procedure Endoscopy procedure
Endoscopy procedure is required to rule out type of reflux disease
Primary outcome measures
- comparison of reflux esophagitis in cases who undergo POEM procedure versus those without esophageal motility disorders [Time frame: 3 months]
- Assessment of the , esophageal acid exposure [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
India · 1 center
- Asian Institute of Gastroenterology Hospital — Hyderabad
Identifiers
NCT: NCT06835374 · REP