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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

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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Recruitment Status : Withdrawn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

June 14, 2012
June 29, 2012
November 10, 2015
June 2012
June 2014   (Final data collection date for primary outcome measure)
Proportions of patients with gastric varices develops rebleed after complete gastric varices obturation in 2 years [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT01631890 on ClinicalTrials.gov Archive Site
  • Proportion of patients who will achieve complete Gastric variceal obliteration in both groups [ Time Frame: 2 years ]
  • Proportions of patients who will show adverse effects of gastric variceal obturation by N Butyl cyanoacrylate. [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
 
To Compare the Efficacy of Endoscopic Ultrasound Assisted Endoscopic Glue Injection and Conventional Endoscopic Injection Therapy for Prevention of Gastric Variceal Rebleed
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Bleeding Gastric Varices
  • 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.
  • 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.
  • Active Comparator: standard endotherapy
    Intervention: Procedure: Standard Endotherapy
  • Experimental: Endoscopic Ultrasound assisted endoscopic glue injection
    Intervention: Procedure: Endoscopic Ultrasound assisted endoscopic glue injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
90
June 2014
June 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01631890
ILBS- EUS-001
No
Not Provided
Not Provided
Institute of Liver and Biliary Sciences, India
Institute of Liver and Biliary Sciences, India
Not Provided
Principal Investigator: Ashok Kr Choudhury Institute of Liver and Biliary Sciences
Institute of Liver and Biliary Sciences, India
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP