To Compare the Efficacy of Endoscopic Ultrasound Assisted Endoscopic Glue Injection and Conventional Endoscopic Injection Therapy for Prevention of Gastric Variceal Rebleed

November 7, 2015 updated by: Institute of Liver and Biliary Sciences, India

Phase III Study of the Efficacy of Endoscopic Ultrasound (EUS) Assisted Endoscopic Glue Injection and Conventional Endoscopic Injection Therapy for Prevention of Gastric Variceal Rebleed

Consecutive patients who meet the eligibility criteria will be enrolled into the study. All patients with gastric varices with no history of gastric variceal bleed (Group C) will undergo Endoscopic ultrasound and Upper Gastrointestinal Endoscopy at baseline, at the end of first year and at the end of study.

The patients who presented to Institute of Liver and Biliary Sciences with gastric variceal bleed or develop Gastric Variceal bleed during hospital stay will be randomized into Group -A (conventional Upper Gastrointestinal Endoscopy + Glue) and Group-B (Endoscopic Ultrasound followed by Upper Gastrointestinal Endoscopy+Glue) therapy for gastric varices. Total 90 patients will be enrolled and randomized into group A and Group B after resuscitation and urgent Upper Gastrointestinal Endoscopy with standard therapy for bleeding gastric varices to achieve hemostasis.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Institute of liver and Biliary Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A clinical, radiological or histologic diagnosis of cirrhosis
  • Upper Gastrointestinal endoscopy showing gastric varices
  • Informed consent to participate in the study

Exclusion Criteria:

  • Previous endotherapy (Endoscopic Variceal Ligation/Esophageal Variceal Sclerotherapy/Endoscopic Variceal Obliteration) for gastric variceal haemorrhage
  • Diagnosed case of HepatoPulmonary Syndrome.
  • Non -cirrhotic portal hypertension/Extra hepatic Portal Venous Obstruction
  • transhepatic intrajugular portosystemic shunt, (balloon-occluded retrograde transvenous obliteration), balloon-occluded endoscopic injection sclerotherapy, shunt operation.
  • Hepatic encephalopathy grade III/IV,
  • Cardio respiratory failure
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard endotherapy
Procedure: Standard Endotherapy
Patients will be stabilized by giving i/v fluids, blood and blood products. Injection terlipressin will be given to all patients in a bolus dose of 2mg within 30 minutes of admission to the hospital. This would be followed by 1mg i/v 6hrly and will be continued for 5 days. If terlipressin cannot given then inj.somatostatin 500mcg IV bolus followed by 250mcg/hr continuous infusion for 5days.
Experimental: Endoscopic Ultrasound assisted endoscopic glue injection
Procedure: Endoscopic Ultrasound assisted endoscopic glue injection
N Butyl cyanoacrylate will be used for achieving initial hemostasis during active gastric variceal bleed and during follow up gastric variceal obturation. Endoscopic injection will be performed intravariceally using a therapeutic endoscope and a steel hubbed catheter, with N-butyl-2-cyanoacrylate. The cyanoacrylate will be injected without dilution with lipiodol. The tip of the endoscope will be coated with lipiodol to prevent sticking of glue to the endoscope. The injection catheter is primed with saline solution followed by injection of glue in 1ml aliquot to fill the dead space followed by injection of sterile water to flush the glue into the varix. The needle is withdrawn immediately after the glue injection to prevent tissue adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportions of patients with gastric varices develops rebleed after complete gastric varices obturation in 2 years
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients who will achieve complete Gastric variceal obliteration in both groups
Time Frame: 2 years
2 years
Proportions of patients who will show adverse effects of gastric variceal obturation by N Butyl cyanoacrylate.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Liver and Biliary Sciences, India

Investigators

  • Principal Investigator: Ashok Kr Choudhury, Institute of liver and Biliary Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

June 14, 2012

First Submitted That Met QC Criteria

June 28, 2012

First Posted (Estimate)

June 29, 2012

Study Record Updates

Last Update Posted (Estimate)

November 10, 2015

Last Update Submitted That Met QC Criteria

November 7, 2015

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBS- EUS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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