NCT02739581

Brief Summary

The patients will be randomized into two groups

  1. 1.Endoscopic Variceal Ligation with Non Selective Beta Blocker
  2. 2.Placebo with Endoscopic Variceal Ligation

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

First QC Date

April 12, 2016

Last Update Submit

October 8, 2019

Conditions

Advanced Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Recurrence of variceal bleeding

    12 months

Secondary Outcomes (11)

  • Recurrence of variceal bleeding

    24 months

  • Survival

    12 months

  • Survival

    24 months

  • Bleeding severity in both arms

    12 months

  • Bleeding severity in both arms

    24 months

  • +6 more secondary outcomes

Study Arms (2)

Endoscopic variceal ligation with Non-selective B-blockers

EXPERIMENTAL
Procedure: Endoscopic Variceal LigationDrug: Non selective beta blocker

Endoscopic variceal ligation with Placebo

ACTIVE COMPARATOR
Procedure: Endoscopic Variceal LigationOther: Placebo

Interventions

Endoscopic Variceal LigationPROCEDURE
Endoscopic variceal ligation with Non-selective B-blockersEndoscopic variceal ligation with Placebo
Non selective beta blockerDRUG
Endoscopic variceal ligation with Non-selective B-blockers
PlaceboOTHER
Endoscopic variceal ligation with Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between 18 and 80 years old.
  • Clinical criteria and/or analytical, ultrasound and/or liver biopsy consistent with the diagnosis of liver cirrhosis.
  • Written informed consent to participate in the study.
  • Child C status, CTP \>10

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Study Officials

  • Dr Ankur Jindal, MD

    Institute of Liver and Biliary Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2016

First Posted

April 15, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

October 10, 2019

Record last verified: 2019-10

Locations

IN(1)