Clinical trial NCT06835374: Comparative Assessment of Esophagitis in Cases With and Without Esophageal Motility Disorders: A Prospective Study
Official title: Comparative Assessment of Reflux Esophagitis in Cases With and Without Esophageal Motility Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Diseases
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

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.

Eligibility criteria: Inclusion Criteria:

1. Age≥18y,
2. confirmed diagnosis of Achalasia,
3. No contraindication to POEM,
4. erosive esophagitis on endoscopy

Exclusion Criteria:

1. Non-esophageal esophageal motility disorders,
2. Treatment other than POEM,
3. current PPI use before assessment for GERD

Primary outcomes:
measure: comparison of reflux esophagitis in cases who undergo POEM procedure versus those without esophageal motility disorders
timeFrame: 3 months
measure: Assessment of the , esophageal acid exposure
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology Hospital
state: Telangana
Study officials:
affiliation: AIG Hospitals
name: Zaheer Nabi Dr Mohammed, MBBS MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AIG Hospitals
name: Chinmay Dr Hegde, MBBS MD
role: PRINCIPAL_INVESTIGATOR
References: