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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03069339
• Other study ID #: ILBS-Cirrhosis-07
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 15, 2017
• Est. completion date: November 30, 2020

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 330
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ß 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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

Drug:
• 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

Procedure:
• Endoscopic Variceal Ligation
EVL will be done every 3 weeks till eradication

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	Reduction in the incidence of first variceal bleed at 1 year.		1 year
Secondary	Overall and bleed related Survival in all the 3 groups		1 year
Secondary	Bleed related Survival in all the 3 groups		1 year
Secondary	Improvement in Child-Turcotte-Pugh (CTP) score in all the 3 groups		1 year
Secondary	Improvement in Model for End Stage Liver Disease (MELD) score in all the 3 groups		1 year
Secondary	Incidence of Spontaneous Bacterial Peritonitis (SBP) in all the 3 groups		1 year
Secondary	Incidence of Acute Kidney Injury (AKI) in all the 3 groups		1 year
Secondary	Incidence of Shock in all the 3 groups		1 year
Secondary	Incidence of new ascites in all the 3 groups		1 year
Secondary	HVPG response at 1year in all the 3 groups		1 year
Secondary	Treatment related side effects in all the 3 groups		1 year