Esophageal Diseases
Conditions
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.
Interventions
PROCEDUREPer oral endoscopy myotomy (Per oral endoscopy myotomy)
POEM is the procedure to reduce the symptoms of dysphagia, regurgitation.
PROCEDUREEndoscopy procedure
Endoscopy procedure is required to rule out type of reflux disease
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
India
Contacts
CONTACTRajesh Goud Mr Maragoni, M.Pharm, MBA
CONTACTZaheer Nabi Dr Mohammed, MBBS MD
PRINCIPAL_INVESTIGATORZaheer Nabi Dr Mohammed, MBBS MD
AIG Hospitals
PRINCIPAL_INVESTIGATORChinmay Dr Hegde, MBBS MD
AIG Hospitals
Outcome results
None listed