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

February 7, 2025 updated by: Mohan Ramchandani, Asian Institute of Gastroenterology, India

Risk Factors for Sub Mucosal Fibrosis During Achalasia Cardia

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

339

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 500079
        • Completed
        • Asian institute of Gastroenterology/AIG Hospitals
      • Hyderabad, Telangana, India, 500082
        • Recruiting
        • Asian Institute of Gastroenterology /Aig Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

339 subjects

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
100 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian Institute of Gastroenterology, India

Investigators

  • Principal Investigator: Zaheer Nabi Dr Mohammed, MBBS MD, AIG Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2021

Primary Completion (Estimated)

February 20, 2025

Study Completion (Estimated)

April 20, 2025

Study Registration Dates

First Submitted

February 4, 2025

First Submitted That Met QC Criteria

February 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esophagus Disorder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe