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

NCT ID: NCT01631890

Last Updated: 2015-11-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-06-30

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.

Conditions

Bleeding Gastric Varices

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

standard endotherapy

Group Type: ACTIVE_COMPARATOR

Standard Endotherapy

Intervention Type: PROCEDURE

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.

Endoscopic Ultrasound assisted endoscopic glue injection

Group Type: EXPERIMENTAL

Endoscopic Ultrasound assisted endoscopic glue injection

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashok Kr Choudhury

Role: PRINCIPAL_INVESTIGATOR

Institute of Liver and Biliary Sciences

Locations

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

ILBS- EUS-001

Identifier Type: -

Identifier Source: org_study_id