| CTRI Number |
CTRI/2025/01/079806 [Registered on: 30/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Carvedilol drug Versus Combination of carvedilol drug and Endoscopic Variceal Ligation (a procedure) for liver cancer patients. |
|
Scientific Title of Study
|
Comparative Study of Carvedilol Monotherapy Versus Combination Therapy With Endoscopic Variceal Ligation (EVL) for Primary Prophylaxis of Variceal Bleeding in Patients With Hepatocellular Carcinoma With High-Risk Esophageal Varices: A Randomized Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| None |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarthak Chanana |
| Designation |
Senior Resident,Department of hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3442, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
xs2sarthak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Choudhury |
| Designation |
Additional Professor, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3442, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
doctor.ashokchoudhury@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Choudhury |
| Designation |
Additional Professor, Department of Hepatology |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Room No. 3442, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI
110070
India |
| Phone |
01146300000 |
| Fax |
|
| Email |
doctor.ashokchoudhury@gmail.com |
|
|
Source of Monetary or Material Support
|
| ILBS,D-1,Vasant Kunj,New Delhi-110070, India. |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
D-1,Vasant Kunj,New Delhi-110070, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sarthak Chanana |
Institute of Liver and Biliary Sciences |
Room No. 3311, Department of Hepatology, Phase II, 3rd Floor, D-1, Vasant Kunj, New Delhi-110070.
South West
DELHI |
01146300000
xs2sarthak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ILBS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K769||Liver disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NSBB |
Non-selective beta blocker (Carvedilol 3.125 mg BD for 3 days followed by 6.25 mg BD , maximum dose would be 12.5 mg BD , same shall be switch to maximum tolerable dose if Systolic BP less than 90 , HR less than 55). |
| Intervention |
NSBB with EVL |
Non-selective beta blocker (Carvedilol 3.125 mg BD for 3 days followed by 6.25 mg BD , maximum dose would be 12.5 mg BD , same shall be switch to maximum tolerable dose if Systolic BP less than 90 , HR less than 55) + EVL every 3 weeks till eradication of varices followed by every 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-80 years
2. Cirrhosis with HCC
3. High risk oesophageal varices (large or small with RCS)
4. Valid consent
|
|
| ExclusionCriteria |
| Details |
1. Any contra-indication to beta-blockers
2. Any EVL or Sclerotherapy within last 3 months
3. Any past history of TIPS or surgery for portal hypertension
4. HCC with BCLC-D
5. Patients with past history of variceal bleed.
6. Patient With Liver transplant expected in next 2 weeks would be excluded |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of combination of Carvedilol with EVL over Carvedilol in prevention of index variceal bleed in a period of 6 months follow up among cirrhosis patients with HCC and high risk esophageal varices. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the impact of TKI/Immunotherapy on variceal bleed. |
6 months |
| To study the impact of PVTT on Variceal bleed |
6 months |
| Post EVL Ulcer bleed incidence and outcome |
6 months |
| To study effect of beta blocker on non invasive test for portal hypertension -LSM, SSM, APRI Score, ALBI Score and FIB-4,D-Dimer. |
6 months |
| To study impact of locoregional therapy like SBRT on variceal bleed. |
6 months |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Esophageal varices are common in patients with hepatocellular carcinoma (HCC), with an incidence rate of 63% at the time of HCC diagnosis. Following an acute variceal bleed, the 6-week mortality rate for HCC patients is as high as 26%. Mortality rates escalate notably in HCC patients experiencing acute variceal bleeding, especially with increasing cancer severity indicated by BLCL status. Research suggests that the cumulative incidence rate of variceal bleeding at one year in patients receiving primary prophylaxis is almost half that of patients not receiving any prophylaxis. Beta blockers are the standard therapy for primary prophylaxis in patients with portal hypertension to prevent variceal bleeding. Endoscopic band ligation has also shown promising results in recent studies. However, the combined impact of beta blockers and esophageal band ligation on lowering the incidence of variceal bleeding remains unstudied. The aim of this study is to compare the efficacy of carvedilol monotherapy versus combination therapy with carvedilol and endoscopic band ligation in patients with HCC for primary prophylaxis of high-risk esophageal varices.
Study population: All patients aged more than equals to 18 years and less than equals to 80 years admitted in Institute of Liver and Biliary Sciences, New Delhi with HCC of any cause and high risk esophageal varices and are giving written consent for participation in the study. Study design - Single center, Open label, Randomized controlled trial Study period – 6 months
|