Risk Factors for Sub Mucosal Fibrosis During Achalasia Cardia: A Prospective Study

Risk Factors for Sub Mucosal Fibrosis During Achalasia Cardia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06815341

Enrollment

339

Registered

2025-02-07

Start date

2021-08-14

Completion date

2025-04-20

Last updated

2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagus Disorder

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
The primary aim of the study is to evaluate the predictors for Sub mucosal fibrosis in cases with achalasia cardia.	100 minutes	sub mucosal fibres determination in different muscles of esophagus

Secondary

Measure	Time frame	Description
: To improve the technical outcomes of per oral endoscopy myotomy	100 minutes	to know the efficacy of procedure

Countries

India

Contacts

Primary ContactRajesh Goud Mr Maragoni, M.Pharm, MBA

rajeshgoud761@gmail.com04023378888

Backup ContactZaheer Nabi Dr Mohammed, MBBS MD

zaheernabi1978@gmail.com04023378888

Outcome results