Carvedilol, Endoscopic Variceal Ligation or Combination of Both for Prevention of First Variceal Bleed in Child's B & C Cirrhosis

Carvedilol, Endoscopic Variceal Ligation or Combination of Both for Prevention of First Variceal Bleed in Child's B & C Cirrhosis: A Randomized Controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03069339

Enrollment

330

Registered

2017-03-03

Start date

2017-03-15

Completion date

2020-11-30

Last updated

2020-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis

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

Interventions

DRUGCarvedilol

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

PROCEDUREEndoscopic Variceal Ligation

EVL will be done every 3 weeks till eradication

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Reduction in the incidence of first variceal bleed at 1 year.	1 year

Secondary

Measure	Time frame
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
Overall and bleed related Survival in all the 3 groups	1 year
Incidence of Shock in all the 3 groups	1 year
Incidence of new ascites in all the 3 groups	1 year
HVPG response at 1year in all the 3 groups	1 year
Treatment related side effects in all the 3 groups	1 year
Incidence of Acute Kidney Injury (AKI) in all the 3 groups	1 year

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026