Hepatocellular Carcinoma With Portal Vein ThrombosisNCT01659346
Non-selective Beta Blockers Versus EVL for Primary Prophylaxis of Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis.
A study testing Endoscopic Variceal Ligation and Carvedilol in people with Hepatocellular Carcinoma With Portal Vein Thrombosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Every patient with HCC (Hepato-Cellular Carcinoma) with main portal vein thrombosis will be screened for presence of large esophageal varices and will be randomized between non-selective beta blocker versus primary endoscopic variceal ligation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatocellular Carcinoma With Portal Vein Thrombosis
- What is being tested?
- Endoscopic Variceal Ligation and Carvedilol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of cirrhosis with Hepatocellular carcinoma and portal vein thrombosis
- Presence of large oesophageal varices or small with high risk
Who cannot join
- Any contra-indication to beta-blockers
- Any Endoscopic Variceal Ligation or Sclerotherapy within last 3 months
- High risk gastric varices
- Any past history of Transhepatic Intrajugular Portosystemic Shunt or surgery for portal hypertension
- Significant cardio or pulmonary co-morbidity
- Any extrahepatic malignancy
Show all 9Show fewer
- Patients with past history of variceal bleed
- Patients with non-tumor portal vein thrombosis
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: A Prospective Randomized Controlled Trial Comparing Non-selective Beta Blockers Versus EVL for Primary Prophylaxis of Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis
Every patient with HCC (Hepato-Cellular Carcinoma) with main portal vein thrombosis will be screened for presence of large esophageal varices and will be randomized between non-selective beta blocker versus primary endoscopic variceal ligation. They will be followed to assess the rate of reduction of index bleed rate as well as survival difference between the groups.
- Being tested
- Endoscopic Variceal Ligation, Carvedilol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Variceal LigationProcedure or surgery
Endoscopic Variceal Ligation every 3 weeks till eradication.
CarvedilolDrug
Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Variceal Ligation | Experimental | Endoscopic Variceal Ligation every 3 weeks till eradication Receives: Procedure: Endoscopic Variceal Ligation |
| Carvedilol | Active comparator | Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD Receives: Drug: Carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Variceal Bleeding
Measured: 1.5 years
Secondary outcomes (3)
Death
Measured: 1.5 years
Procedure related complications.
Measured: 1.5 years
Reappearance of Esophageal varices in presence of Portal Vein Thrombosis
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startFeb 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Due to high mortality
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma With Portal Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Shakti P Choudhury, MD, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659346
- Sponsor's protocol ID
- ILBS-HCC-01
- Status last verified
- Sep 2017
- First submitted
- 4 Aug 2012
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Comparing Non-selective Beta Blockers Versus EVL for Primary Prophylaxis of Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis
- ClinicalTrials.gov ID
- NCT01659346
- Acronym / sponsor ID
- ILBS-HCC-01
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to high mortality
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 7 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Every patient with HCC (Hepato-Cellular Carcinoma) with main portal vein thrombosis will be screened for presence of large esophageal varices and will be randomized between non-selective beta blocker versus primary endoscopic variceal ligation. They will be followed to assess the rate of reduction of index bleed rate as well as survival difference between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Variceal Ligation | Experimental | Procedure: Endoscopic Variceal LigationEndoscopic Variceal Ligation every 3 weeks till eradication |
| Carvedilol | Active comparator | Drug: CarvedilolCarvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of cirrhosis with Hepatocellular carcinoma and portal vein thrombosis
- Presence of large oesophageal varices or small with high risk
Key exclusion criteria (9 listed)
- Any contra-indication to beta-blockers
- Any Endoscopic Variceal Ligation or Sclerotherapy within last 3 months
- High risk gastric varices
- Any past history of Transhepatic Intrajugular Portosystemic Shunt or surgery for portal hypertension
- Significant cardio or pulmonary co-morbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Variceal LigationEndoscopic Variceal Ligation every 3 weeks till eradication. | Procedure or surgery | Endoscopic Variceal Ligation |
| CarvedilolCarvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD | Drug | Carvedilol |
Primary outcome
First Variceal Bleeding
Time frame: 1.5 years
3 secondary outcomes
Death
Time frame: 1.5 years
Procedure related complications.
Time frame: 1.5 years
Reappearance of Esophageal varices in presence of Portal Vein Thrombosis
Time frame: 1.5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatocellular Carcinoma With Portal Vein Thrombosis
RecruitingPhase 2
BITS-TO-HCC Study: HAIC+Iparomlimab/Tuvonralimab + Bevacizumab + Surgery/SBRT for BCLC-C HCC With PVTT and/or Oligometastases
Hepatocellular Carcinoma, Portal Vein Tumor Thrombus
RecruitingPhase 2
Iparomlimab and Tuvonralimab With Lenvatinib, Radiotherapy, and HAIC for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
HCC - Hepatocellular Carcinoma
Recruiting
IRE After Targeted Immunotherapy in HCC With Portal Vein Tumor Thrombus
IRE
RecruitingPhase 2
Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma With Localized Portal Vein Tumor Thrombosis
Hepatocellular Carcinoma
RecruitingPhase 2
Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT
Hepatocellular Carcinoma Non-resectable
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Shakti P Choudhury, MD principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Variceal Ligation and Carvedilol in people with Hepatocellular Carcinoma With Portal Vein Thrombosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Variceal Bleeding (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.