Carvedilol, Endoscopic Variceal Ligation or Combination of Both for Prevention of First Variceal Bleed in Child's B & C Cirrhosis
1 other identifier
interventional
330
1 country
1
Brief Summary
Study Design: Open labeled randomized controlled trial. The study will be conducted on patients attending outpatient or admitted to admitted to Department of Hepatology from January 2017 to December 2018 at ILBS, New Delhi
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2017
CompletedFirst Posted
Study publicly available on registry
March 3, 2017
CompletedStudy Start
First participant enrolled
March 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedFebruary 19, 2020
October 1, 2019
3.7 years
February 28, 2017
February 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in the incidence of first variceal bleed at 1 year.
1 year
Secondary Outcomes (10)
Overall and bleed related Survival in all the 3 groups
1 year
Bleed related Survival in all the 3 groups
1 year
Improvement in Child-Turcotte-Pugh (CTP) score in all the 3 groups
1 year
Improvement in Model for End Stage Liver Disease (MELD) score in all the 3 groups
1 year
Incidence of Spontaneous Bacterial Peritonitis (SBP) in all the 3 groups
1 year
- +5 more secondary outcomes
Study Arms (3)
Carvedilol+EVL
EXPERIMENTALCarvedilol
EXPERIMENTALEVL
ACTIVE COMPARATORInterventions
Carvedilol will start at starting dose of 3.125 mg BD followed by 6.25 mg BD followed by 12.5 mg BD if BP 90/60 mmHg and HR 55/min
EVL will be done every 3 weeks till eradication
Eligibility Criteria
You may qualify if:
- Liver Cirrhotics between 18-70 yrs of age (cirrhosis diagnosed on the basis of clinical, biochemical, fibroscan \& imaging.)
- CTP ≥ 7-15 (Child's B/C)
- Small esophageal varices with RCS and large esophageal varices (\>5 mm)
- No history of previous bleed
You may not qualify if:
- Malignancy-HCC, PVT
- Child A
- MELD \>35
- Contraindications to β blockers.
- Platelet count \< 30,000/mm3
- Previous endoscopic variceal treatment. (Beyond 21 days)
- Patients having an indication for TIPS or requiring more than 1 therapeutic ascitic tapping/month
- Post TIPS, Shunt surgery
- Acute kidney injury (Sr.Cr\>1.5mg/dl)
- Non cirrhotic portal hypertension
- Acute on chronic liver failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
Related Publications (1)
Tevethia HV, Pande A, Vijayaraghavan R, Kumar G, Sarin SK. Combination of carvedilol with variceal band ligation in prevention of first variceal bleed in Child-Turcotte-Pugh B and C cirrhosis with high-risk oesophageal varices: the 'CAVARLY TRIAL'. Gut. 2024 Oct 7;73(11):1844-1853. doi: 10.1136/gutjnl-2023-331181.
PMID: 39067870DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2017
First Posted
March 3, 2017
Study Start
March 15, 2017
Primary Completion
November 30, 2020
Study Completion
November 30, 2020
Last Updated
February 19, 2020
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share