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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01631890
Recruitment Status : Withdrawn
First Posted : June 29, 2012
Last Update Posted : November 10, 2015
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Bleeding Gastric Varices Procedure: Endoscopic Ultrasound assisted endoscopic glue injection Procedure: Standard Endotherapy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportions of patients with gastric varices develops rebleed after complete gastric varices obturation in 2 years [ Time Frame: 2 years ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT01631890


Locations
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India
Institute of Liver and Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
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Principal Investigator: Ashok Kr Choudhury Institute of Liver and Biliary Sciences
More Information
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01631890    
Other Study ID Numbers: ILBS- EUS-001
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: June 2012
Additional relevant MeSH terms:
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Esophageal and Gastric Varices
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Hypertension, Portal
Liver Diseases