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

Advanced Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02739581
• Other study ID #: ILBS-Cirrhosis-04
• Status: Withdrawn
• Phase: N/A
• Est. completion date: April 2019

Study information

• Verified date: October 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

Procedure:
• Endoscopic Variceal Ligation

Drug:
• Non selective beta blocker

Other:
• Placebo

Locations

Country	Name	City	State
India	Institute of liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

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