| CTRI Number |
CTRI/2024/06/069154 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of obstructive causes of jaundice by using USG and CT |
|
Scientific Title of Study
|
Evaluation of obstructive jaundice by using ultrasonography vs computed tomography |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Vora Kaushar |
| Designation |
First year resident |
| Affiliation |
Government Medical College and Sir Takhtasinhji General Hospital |
| Address |
Radiodiagnosis department, Government medical college, Bhavnagar.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9727746444 |
| Fax |
|
| Email |
vorakaushar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mehandi Vadsaria |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Medical College and Sir Takhtasinhji General Hospital |
| Address |
Radiodiagnosis department, Government medical college, Bhavnagar.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9824220670 |
| Fax |
|
| Email |
drmehandi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Vora Kaushar |
| Designation |
First year resident |
| Affiliation |
Government Medical College and Sir Takhtasinhji General Hospital |
| Address |
Radiodiagnosis department, Government medical college, Bhavnagar.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9727746444 |
| Fax |
|
| Email |
vorakaushar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Takhtasinhji general hospital and government medical college, Bhavnagar, Gujarat, India.
Pincode- 364001. |
|
|
Primary Sponsor
|
| Name |
NOT APPLICABLE |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [NOT APPLICABLE] |
|
|
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 Vora Kaushar |
Sir Takhtasinhji general hospital |
Room no 6 and 9, Radiodiagnosis department, Government medical college
Bhavnagar
GUJARAT |
09727746444
vorakaushar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics comittee, Government medical college, Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K831||Obstruction of bile duct, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with high bilirubin having obstructive jaundice on USG and subsequently undergone CECT abdomen.
|
|
| ExclusionCriteria |
| Details |
Patient having medical jaundice.
Pregnant females.
Patient who has renal insufficiency.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Exposure: Obstructive jaundice
Outcome: USG and CT findings.
Confounding: age, gender
|
Baseline
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/07/2024 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Hepatobiliary
pathology includes group of diseases of liver and biliary system. Diseases of
liver
comprises liver abscess, focal nodular hyperplasia, alcoholic live disease,
hemangioma,
hepatocellular carcinoma, metastasis.
While,
diseases of biliary systems include cholelithiasis, pancreatitis,
cholangiocarcinoma,
periampullary carcinoma, choledochal cyst
The role of
imaging in patients with suspected bile duct obstruction is not only to confirm
the presence
of hepatobiliary obstruction, but also to determine the level and cause of
obstruction
and the extent or stage of the disease process. Detailed information for
diagnosis of
biliary obstruction is usually obtained by the combined use of
ultrasonography
(USG), computed tomography (CT).
|