Clinical trial NCT02739581: 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
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Advanced Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of variceal bleeding
timeFrame: 12 months
Secondary outcomes:
measure: Recurrence of variceal bleeding
timeFrame: 24 months
measure: Survival
timeFrame: 12 months
measure: Survival
timeFrame: 24 months
measure: Bleeding severity in both arms
timeFrame: 12 months
measure: Bleeding severity in both arms
timeFrame: 24 months
measure: Incidence or progression of Portal Hypertension complications such as ascites control in both arms.
timeFrame: 12 months
measure: Incidence or progression of Portal Hypertension complications such as Spontaneous Bacterial Peritonitis in both arms.
timeFrame: 12 months
measure: Incidence or progression of Portal Hypertension complications such as Hepatorenal syndrome in both arms.
timeFrame: 12 months
measure: Appearance or progression of Portal Vein Thrombosis in both arms
timeFrame: 12 months
measure: Number of patients receive alternative treatments transhepatic intrajugular portosystemic shunt in both arms.
timeFrame: 12 months
measure: Incidence of adverse events in both groups
timeFrame: 12 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Ankur Jindal, MD
role: PRINCIPAL_INVESTIGATOR
References: