Risk Factors for Sub Mucosal Fibrosis During Achalasia Cardia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 339
- Locations
- 2
- Primary Endpoint
- The primary aim of the study is to evaluate the predictors for Sub mucosal fibrosis in cases with achalasia cardia.
Study Overview
Brief Summary
Classification for Stasis Esophagitis:
Grade I Grade II Grade III Vascular pattern Obscured Obscured Obscured Mucosal thickening No Yes Yes Ulceration No Yes Yes Nodularity No No Yes
Detailed Description
Predictors of Submucosal Fibrosis:
Various factors were analysed for prediction of SMF including age, gender, stasis esophagitis, type of achalasia, duration of disease, lower esophageal sphincter pressure (LESP), height of barium column on barium esophagogram and severity of symptoms (Eckardt score). Esophageal mucosa was graded for the severity of stasis esophagitis (grade I to grade III) based on vascular pattern, mucosal thickening, ulceration and nodularity. SMF was graded (I minimal, II moderate, III severe) according to mucosal lift, difficulty in entry, density of SM fibers, separation of mucosa and muscle.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients (between 18 to 75 years of age) who underwent POEM for achalasia or other esophageal motility disorders.
- •Had a diagnosis of esophageal achalasia confirmed by High Resolution Manometry, barium esophagogram.
Exclusion Criteria
- •Patients who underwent treatment other than achalasia
- •Lost to follow up patients.
- •Incomplete clinical record patients
- •Patients not willing to participate in the study
Outcomes
Primary Outcomes
The primary aim of the study is to evaluate the predictors for Sub mucosal fibrosis in cases with achalasia cardia.
Time Frame: 100 minutes
sub mucosal fibres determination in different muscles of esophagus
Secondary Outcomes
- : To improve the technical outcomes of per oral endoscopy myotomy(100 minutes)
Investigators
Mohan Ramchandani
Director
Asian Institute of Gastroenterology, India