Risk Factors for Sub Mucosal Fibrosis During Achalasia Ca... | NCT06815341

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

NCT06815341

Sponsor

Asian Institute of Gastroenterology, India

Status

Unknown status

Last Update Posted

Feb 11, 2025Actual

Enrollment

339Estimated

Phase

Not provided

Conditions

Esophagus Disorder

Interventions

Not provided

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 14, 2021Actual

Primary Completion Date

Feb 20, 2025Estimated

Completion Date

Apr 20, 2025Estimated

First Submitted Date

Feb 4, 2025

First Submission Date that Met QC Criteria

Feb 4, 2025

First Posted Date

Feb 7, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2025

Last Update Posted Date

Feb 11, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohan Ramchandani, Director, Asian Institute of Gastroenterology, IndiaPrincipal Investigator

Lead Sponsor

Asian Institute of Gastroenterology, IndiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

339Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

339 subjects

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rajesh Goud Mr Maragoni, M.Pharm, MBA	Contact	04023378888	531	rajeshgoud761@gmail.com
Zaheer Nabi Dr Mohammed, MBBS MD	Contact	04023378888	102	zaheernabi1978@gmail.com

Overall Officials

Name	Affiliation	Role
Zaheer Nabi Dr Mohammed, MBBS MD	AIG Hospitals	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asian institute of Gastroenterology/AIG Hospitals	Completed	Hyderabad	Telangana	500079	India

Condition Browse Module

MeSH Terms

ID	Term
D004935	Esophageal Diseases

Ancestor Terms

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided