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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

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ClinicalTrials.gov Identifier: NCT02739581
Recruitment Status : Not yet recruiting
First Posted : April 15, 2016
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

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

Condition or disease Intervention/treatment Phase
Advanced Cirrhosis Procedure: Endoscopic Variceal Ligation Drug: Non selective beta blocker Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis Endoscopy

Arm Intervention/treatment
Experimental: Endoscopic variceal ligation with Non-selective B-blockers Procedure: Endoscopic Variceal Ligation
Drug: Non selective beta blocker
Active Comparator: Endoscopic variceal ligation with Placebo Procedure: Endoscopic Variceal Ligation
Other: Placebo



Primary Outcome Measures :
  1. Recurrence of variceal bleeding [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Recurrence of variceal bleeding [ Time Frame: 24 months ]
  2. Survival [ Time Frame: 12 months ]
  3. Survival [ Time Frame: 24 months ]
  4. Bleeding severity in both arms [ Time Frame: 12 months ]
  5. Bleeding severity in both arms [ Time Frame: 24 months ]
  6. Incidence or progression of Portal Hypertension complications such as ascites control in both arms. [ Time Frame: 12 months ]
  7. Incidence or progression of Portal Hypertension complications such as Spontaneous Bacterial Peritonitis in both arms. [ Time Frame: 12 months ]
  8. Incidence or progression of Portal Hypertension complications such as Hepatorenal syndrome in both arms. [ Time Frame: 12 months ]
  9. Appearance or progression of Portal Vein Thrombosis in both arms [ Time Frame: 12 months ]
  10. Number of patients receive alternative treatments transhepatic intrajugular portosystemic shunt in both arms. [ Time Frame: 12 months ]
  11. Incidence of adverse events in both groups [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739581


Contacts
Contact: Dr Ankur Jindal, MD 011-46300000 ankur.jindal3@gmail.com

Locations
India
Institute of liver and Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
Principal Investigator: Dr Ankur Jindal, MD Institute of Liver and Biliary Sciences

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT02739581     History of Changes
Other Study ID Numbers: ILBS-Cirrhosis-04
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs