| CTRI Number |
CTRI/2024/12/077928 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Predicting Esophageal Varices Using FibroscanInPatients with Chronic Liver Disease |
|
Scientific Title of Study
|
A Cross-Sectional Study For Predicting Esophageal Varices Using FibroscanInPatients with Chronic Liver Disease |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jay Mehta |
| Designation |
DNB Student |
| Affiliation |
Indus International Hospital |
| Address |
Department of General Medicine
Chandigarh Ambala Highway
Derabassi
Rupnagar
PUNJAB
140507
India |
| Phone |
7016827177 |
| Fax |
|
| Email |
jaymehta117.jm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayank Sharma |
| Designation |
HOD General Medicine |
| Affiliation |
Indus International Hospital |
| Address |
Department of General Medicine
Chandigarh Ambala Highway
Derabassi
Rupnagar
PUNJAB
140507
India |
| Phone |
911762512666 |
| Fax |
|
| Email |
drmayanks81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayank Sharma |
| Designation |
HOD General Medicine |
| Affiliation |
Indus International Hospital |
| Address |
Department of General Medicine
Chandigarh Ambala Highway
Derabassi
PUNJAB
140507
India |
| Phone |
911762512666 |
| Fax |
|
| Email |
drmayanks81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Gen Medicine, Indus International Hospital
Chandigarh Ambala Highway
Derabassi, SAS Nagar
Punjab India
140507 |
|
|
Primary Sponsor
|
| Name |
Department of Gen Medicine, Indus International Hospital |
| Address |
Chandigarh Ambala Highway
Derabassi, SAS Nagar, Punjab 140507 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jay Mehta |
Indus International Hospital |
Department of General Medicine
Chandigarh Ambala Highway
Derabassi
Rupnagar
PUNJAB |
07016827177
jaymehta117.jm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indus International Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K703||Alcoholic cirrhosis of liver, (2) ICD-10 Condition: K740||Hepatic fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age ≥18 years and ≤80 years at the time of screening
2. Ability to understand the requirements of the study and to provide informed consent. 3. Newly Diagnosed or Treatment Naïve Patient of chronic liver disease. |
|
| ExclusionCriteria |
| Details |
1. All Severely ill patient who cannot undergo Upper Gastrointestinal Endoscopy.
2. Failure to give informed consen |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To statistically predict the occurrence of esophageal varices using Liver Stiffness
Measurement in Chronic Liver Disease patient. |
At baseline during Fibrocsan
Second post Upper GI Endoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Obtain Liver Stiffness Measurement value via Fibroscan in all patient of ChronicLiver Disease.
To grade Esophageal Varices determined using Upper Gastrointestinal (UGI) Endoscopyin these patients.
To compare the Liver Stiffness Measurement values between Different grades of
Esophageal Varices. |
At baseline Post Fibroscan
Second at post Upper GI Endoscopy |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Bleeding due to rupture of esophageal varices is one of main cause of death in chronic liver
disease , that endoscopy screening is recommended. However Endoscopy in every chronicliver disease patient is not possible due to high burden of disease and unavailability inrural
areas. Also endoscopy is invasive and frequently can not be performed.There is need for simple, reliable, noninvasive method that would allow prediction of esophageal varices without
endoscopy.This will help in identification of high risk patient in whom on endoscopytherewill be high chances of oesophageal varices and thus reduce the risk of bleeding . |