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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2020-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Carvedilol+EVL

Group Type EXPERIMENTAL

Carvedilol

Intervention Type DRUG

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

Endoscopic Variceal Ligation

Intervention Type PROCEDURE

EVL will be done every 3 weeks till eradication

Carvedilol

Group Type EXPERIMENTAL

Carvedilol

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Endoscopic Variceal Ligation

Intervention Type PROCEDURE

EVL will be done every 3 weeks till eradication

Interventions

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Carvedilol

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

Intervention Type DRUG

Endoscopic Variceal Ligation

EVL will be done every 3 weeks till eradication

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No