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

Not Applicable

Withdrawn

• Conditions: Advanced Cirrhosis
• Interventions: Procedure: Endoscopic Variceal Ligation; Drug: Non selective beta blocker; Other: Placebo

• Registration Number: NCT02739581
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

The patients will be randomized into two groups

1. Endoscopic Variceal Ligation with Non Selective Beta Blocker

2. Placebo with Endoscopic Variceal Ligation

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-15
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-08
• Last Update Posted: 2019-10-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic variceal ligation with Placebo	Endoscopic Variceal Ligation	-
Endoscopic variceal ligation with Non-selective B-blockers	Non selective beta blocker	-
Endoscopic variceal ligation with Non-selective B-blockers	Endoscopic Variceal Ligation	-
Endoscopic variceal ligation with Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Recurrence of variceal bleeding	12 months

Secondary Outcome Measures

Name	Time	Method
Survival	24 months
Incidence or progression of Portal Hypertension complications such as ascites control in both arms.	12 months
Incidence or progression of Portal Hypertension complications such as Hepatorenal syndrome in both arms.	12 months
Incidence of adverse events in both groups	12 months
Recurrence of variceal bleeding	24 months
Bleeding severity in both arms	24 months
Incidence or progression of Portal Hypertension complications such as Spontaneous Bacterial Peritonitis in both arms.	12 months
Appearance or progression of Portal Vein Thrombosis in both arms	12 months
Number of patients receive alternative treatments transhepatic intrajugular portosystemic shunt in both arms.	12 months

Trial Locations

Locations (1)

Institute of liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India