| CTRI Number |
CTRI/2023/08/056819 [Registered on: 23/08/2023] Trial Registered Prospectively |
| Last Modified On: |
21/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
CT volumetry: Helping tool for successful reductio in obstructive jaundice in hilar strictures |
|
Scientific Title of Study
|
: Predictors of effective drainage during Biliary stenting of hilar strictures with liver volume assessment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishikesh Malokar |
| Designation |
Senior resident |
| Affiliation |
Topiwala National Medical college and BYL Nair CH Hospital |
| Address |
Department of Gastroenterology,Room 717,endoscopy division 7th floor opd building TNMC BYL Nair CH hopsital Mumbai central Mumbai
Mumbai Central Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
8668716072 |
| Fax |
|
| Email |
malokarr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pravin Rathi |
| Designation |
Professor and Head Department of Gastroenterology |
| Affiliation |
topiwala national medical college and BYL Nair Ch Hospital,Mumbai |
| Address |
Department of Gastroenterology,Room 717,endoscopy division, 7th floor opd building TNMC BYL Nair CH hopsital Mumbai central Mumbai
Mumbai Central Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223027206 |
| Fax |
|
| Email |
rathipmpp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pravin Rathi |
| Designation |
Professor and Head Department of Gastroenterology |
| Affiliation |
topiwala national medical college and BYL Nair Ch Hospital,Mumbai |
| Address |
Department of Gastroenterology,Room 717,endoscopy division, 7th floor opd building TNMC BYL Nair CH hopsital Mumbai central Mumbai
Mumbai Central Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223027206 |
| Fax |
|
| Email |
rathipmpp@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Topiwala national medical college and BYL hospital |
| Address |
Dr.AL NAir road Mumbai central Mumbai 400008 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrRishikesh Malokar |
TNMC BYL NAIR CH HOSPITAL MUMBAI |
Department of Gastroenterology,Room 717,endoscopy division, 7th floor opd building TNMC BYL Nair CH hopsital Mumbai central Mumbai
Mumbai
MAHARASHTRA |
8668716072
malokarr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for academic research project(ECARP), PG Academic Committee, T.N.Medical College and BYL Nair Ch Hospital |
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 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Obstructive jaundice caused by hilar stricture (Bismuth type â…¡ or higher), availability of a CT scan performed prior to ERCP and availability of clinical and laboratory data on the day of ERCP and 30 days post procedure |
|
| ExclusionCriteria |
| Details |
Bismuth type I strictures.
Any hepatic resection before or after ERCP
Operable cases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effective drainage /Clinical success-Decrease in bilirubin 50% at day 7
Complete drainage Bilirubin less than 3mg/dl at day 30 |
day 7 and day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complications,Reenterventions and survival |
DAY 30 and day 90 |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
31/08/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
We will include patients with obstructive jaundice with hilar strictures who are planned for biliary drainage procedures (percutaneous or endoscopic routes, plastic or metallic stents, and unilateral or bilateral hepatic duct drainage). CT scan reports performed within 2 weeks before drainage and clinical biochemical tests performed before and 7, 14, 21 and 30 days after stent placement will be collected. No separate intervention being done for the study only the response of the patients after standard recommended intervention will observed over 30 days. |