Advanced CirrhosisNCT02739581
Efficacy and Safety of Endoscopic Variceal Ligation (EVL) Versus EVL Plus Non-selective B-blockers (NSBB) For Prevention of Variceal Rebleed and Non-bleed Related Complications in Patients With Advanced Cirrhosis
A study testing Endoscopic Variceal Ligation and Non selective beta blocker in people with Advanced Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
The patients will be randomized into two groups 1. Endoscopic Variceal Ligation with Non Selective Beta Blocker 2. Placebo with Endoscopic Variceal Ligation Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Cirrhosis
- What is being tested?
- Endoscopic Variceal Ligation and Non selective beta blocker
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- Start not givento Apr 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 and 80 years old.
- Clinical criteria and/or analytical, ultrasound and/or liver biopsy consistent with the diagnosis of liver cirrhosis.
- Endoscopic Diagnosis of esophageal variceal bleeding within 5 days prior to study inclusion.
- Written informed consent to participate in the study.
- Child C status, CTP >10
Who cannot join
- Pregnancy or lactation
- Serum Creatinine > 2 mg/dl
- Bleeding due to gastric varices.
- Active infection or recent infection < 2 weeks
- Presence of hepatocellular carcinoma or portal vein thrombosis
- Active alcoholism
Show all 10Show fewer
- Pregnancy
- HIV infection
- Severe heart, respiratory or contraindications for beta blockers(severe chronic obstructive pulmonary disease, severe asthma, severe insulin-dependent diabetes mellitus, Brady arrhythmia)
- Not giving consent
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
The patients will be randomized into two groups
- Endoscopic Variceal Ligation with Non Selective Beta Blocker
- Placebo with Endoscopic Variceal Ligation
- Conditions
- Advanced Cirrhosis
- Being tested
- Endoscopic Variceal Ligation, Non selective beta blocker, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Variceal LigationProcedure or surgery
Non selective beta blockerDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic variceal ligation with Non-selective B-blockers | Experimental | Not described Receives: Procedure: Endoscopic Variceal Ligation; Drug: Non selective beta blocker |
| Endoscopic variceal ligation with Placebo | Active comparator | Not described Receives: Procedure: Endoscopic Variceal Ligation; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of variceal bleeding
Measured: 12 months
Secondary outcomes (11)
Recurrence of variceal bleeding
Measured: 24 months
Survival
Measured: 12 months
Survival
Measured: 24 months
Bleeding severity in both arms
Measured: 12 months
Bleeding severity in both arms
Measured: 24 months
Incidence or progression of Portal Hypertension complications such as ascites control in both arms.
Measured: 12 months
Incidence or progression of Portal Hypertension complications such as Spontaneous Bacterial Peritonitis in both arms.
Measured: 12 months
Incidence or progression of Portal Hypertension complications such as Hepatorenal syndrome in both arms.
Measured: 12 months
Appearance or progression of Portal Vein Thrombosis in both arms
Measured: 12 months
Number of patients receive alternative treatments transhepatic intrajugular portosystemic shunt in both arms.
Measured: 12 months
Incidence of adverse events in both groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Why it stopped: Lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CirrhosisStudies 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
- 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 Ankur Jindal, MD, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739581
- Sponsor's protocol ID
- ILBS-Cirrhosis-04
- Status last verified
- Oct 2019
- First submitted
- 12 Apr 2016
- Last updated
- 10 Oct 2019
- 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 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Endoscopic Variceal Ligation (EVL) Versus EVL Plus Non-selective B-blockers (NSBB) For Prevention of Variceal Rebleed and Non-bleed Related Complications in Patients With Advanced Cirrhosis
- ClinicalTrials.gov ID
- NCT02739581
- Acronym / sponsor ID
- ILBS-Cirrhosis-04
- Conditions
- Advanced Cirrhosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 15 Apr 2016 (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.
The patients will be randomized into two groups
- Endoscopic Variceal Ligation with Non Selective Beta Blocker
- Placebo with Endoscopic Variceal Ligation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic variceal ligation with Non-selective B-blockers | Experimental | Procedure: Endoscopic Variceal Ligation, Drug: Non selective beta blocker |
| Endoscopic variceal ligation with Placebo | Active comparator | Procedure: Endoscopic Variceal Ligation, Other: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients between 18 and 80 years old.
- Clinical criteria and/or analytical, ultrasound and/or liver biopsy consistent with the diagnosis of liver cirrhosis.
- Endoscopic Diagnosis of esophageal variceal bleeding within 5 days prior to study inclusion.
- Written informed consent to participate in the study.
- Child C status, CTP >10
Key exclusion criteria (10 listed)
- Pregnancy or lactation
- Serum Creatinine > 2 mg/dl
- Bleeding due to gastric varices.
- Active infection or recent infection < 2 weeks
- Presence of hepatocellular carcinoma or portal vein thrombosis
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 Ligation | Procedure or surgery | Endoscopic variceal ligation with Non-selective B-blockers, Endoscopic variceal ligation with Placebo |
| Non selective beta blocker | Drug | Endoscopic variceal ligation with Non-selective B-blockers |
| Placebo | Other | Endoscopic variceal ligation with Placebo |
Primary outcome
Recurrence of variceal bleeding
Time frame: 12 months
11 secondary outcomes
Recurrence of variceal bleeding
Time frame: 24 months
Survival
Time frame: 12 months
Survival
Time frame: 24 months
Bleeding severity in both arms
Time frame: 12 months
Bleeding severity in both arms
Time frame: 24 months
Incidence or progression of Portal Hypertension complications such as ascites control in both arms.
Time frame: 12 months
Incidence or progression of Portal Hypertension complications such as Spontaneous Bacterial Peritonitis in both arms.
Time frame: 12 months
Incidence or progression of Portal Hypertension complications such as Hepatorenal syndrome in both arms.
Time frame: 12 months
Appearance or progression of Portal Vein Thrombosis in both arms
Time frame: 12 months
Number of patients receive alternative treatments transhepatic intrajugular portosystemic shunt in both arms.
Time frame: 12 months
Incidence of adverse events in both groups
Time frame: 12 months
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 10 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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 Ankur Jindal, 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 Non selective beta blocker in people with Advanced Cirrhosis, 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 5 inclusion and 10 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 10 Oct 2019. 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?
Recurrence of variceal bleeding (time frame: 12 months). 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 10 Oct 2019.