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

NCT ID: NCT06815341

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

339 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-14

Study Completion Date

2025-04-20

Brief Summary

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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

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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.

Conditions

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Esophagus Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asian Institute of Gastroenterology, India

OTHER

Sponsor Role lead

Responsible Party

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Mohan Ramchandani

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zaheer Nabi Dr Mohammed, MBBS MD

Role: PRINCIPAL_INVESTIGATOR

AIG Hospitals

Locations

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Asian institute of Gastroenterology/AIG Hospitals

Hyderabad, Telangana, India

Site Status COMPLETED

Asian Institute of Gastroenterology /Aig Hospitals

Hyderabad, Telangana, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Rajesh Goud Mr Maragoni, M.Pharm, MBA

Role: CONTACT

04023378888 ext. 531

Zaheer Nabi Dr Mohammed, MBBS MD

Role: CONTACT

04023378888 ext. 102

Facility Contacts

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ZAHEER DR NABI, MBBS MDDNB

Role: primary

04023378888

Other Identifiers

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SMF

Identifier Type: -

Identifier Source: org_study_id

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