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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

Primary Purpose

Advanced Cirrhosis

Status

Withdrawn

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Endoscopic Variceal Ligation

Non selective beta blocker

Placebo

About this trial

This is an interventional treatment trial for Advanced Cirrhosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institute of liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endoscopic variceal ligation with Non-selective B-blockers

Endoscopic variceal ligation with Placebo

Arm Description

Outcomes

Primary Outcome Measures

Recurrence of variceal bleeding

Secondary Outcome Measures

Recurrence of variceal bleeding

Survival

Bleeding severity in both arms

Incidence or progression of Portal Hypertension complications such as ascites control in both arms.

Incidence or progression of Portal Hypertension complications such as Spontaneous Bacterial Peritonitis in both arms.

Incidence or progression of Portal Hypertension complications such as Hepatorenal syndrome in both arms.

Appearance or progression of Portal Vein Thrombosis in both arms

Number of patients receive alternative treatments transhepatic intrajugular portosystemic shunt in both arms.

Incidence of adverse events in both groups

Full Information

NCT ID

NCT02739581

First Posted

April 12, 2016

Last Updated

October 8, 2019

Sponsor

Institute of Liver and Biliary Sciences, India

1. Study Identification

Unique Protocol Identification Number

NCT02739581

Brief 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

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of funds

Study Start Date

undefined (undefined)

Primary Completion Date

April 2019 (Anticipated)

Study Completion Date

April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The patients will be randomized into two groups Endoscopic Variceal Ligation with Non Selective Beta Blocker Placebo with Endoscopic Variceal Ligation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Cirrhosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endoscopic variceal ligation with Non-selective B-blockers

Arm Type

Experimental

Arm Title

Endoscopic variceal ligation with Placebo

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Endoscopic Variceal Ligation

Intervention Type

Drug

Intervention Name(s)

Non selective beta blocker

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Recurrence of variceal bleeding

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Recurrence of variceal bleeding

Time Frame

24 months

Title

Survival

Time Frame

12 months

Title

Survival

Time Frame

24 months

Title

Bleeding severity in both arms

Time Frame

12 months

Title

Bleeding severity in both arms

Time Frame

24 months

Title

Incidence or progression of Portal Hypertension complications such as ascites control in both arms.

Time Frame

12 months

Title

Incidence or progression of Portal Hypertension complications such as Spontaneous Bacterial Peritonitis in both arms.

Time Frame

12 months

Title

Incidence or progression of Portal Hypertension complications such as Hepatorenal syndrome in both arms.

Time Frame

12 months

Title

Appearance or progression of Portal Vein Thrombosis in both arms

Time Frame

12 months

Title

Number of patients receive alternative treatments transhepatic intrajugular portosystemic shunt in both arms.

Time Frame

12 months

Title

Incidence of adverse events in both groups

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr Ankur Jindal, MD

Organizational Affiliation

Institute of Liver and Biliary Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of liver and Biliary Sciences

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110070

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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