To Compare the Efficacy of Endoscopic Ultrasound Assisted Endoscopic Glue Injection and Conventional Endoscopic Injection Therapy for Prevention of Gastric Variceal Rebleed
Primary Purpose
Bleeding Gastric Varices
Status
Withdrawn
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Endoscopic Ultrasound assisted endoscopic glue injection
Standard Endotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Bleeding Gastric Varices
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
Sites / Locations
- Institute of Liver and Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
standard endotherapy
Endoscopic Ultrasound assisted endoscopic glue injection
Arm Description
Outcomes
Primary Outcome Measures
Proportions of patients with gastric varices develops rebleed after complete gastric varices obturation in 2 years
Secondary Outcome Measures
Proportion of patients who will achieve complete Gastric variceal obliteration in both groups
Proportions of patients who will show adverse effects of gastric variceal obturation by N Butyl cyanoacrylate.
Full Information
NCT ID
NCT01631890
First Posted
June 14, 2012
Last Updated
November 7, 2015
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT01631890
Brief Title
To Compare the Efficacy of Endoscopic Ultrasound Assisted Endoscopic Glue Injection and Conventional Endoscopic Injection Therapy for Prevention of Gastric Variceal Rebleed
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 Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Withdrawn
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Gastric Varices
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard endotherapy
Arm Type
Active Comparator
Arm Title
Endoscopic Ultrasound assisted endoscopic glue injection
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Ultrasound assisted endoscopic glue injection
Intervention Description
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
Intervention Name(s)
Standard Endotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportions of patients with gastric varices develops rebleed after complete gastric varices obturation in 2 years
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Proportion of patients who will achieve complete Gastric variceal obliteration in both groups
Time Frame
2 years
Title
Proportions of patients who will show adverse effects of gastric variceal obturation by N Butyl cyanoacrylate.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashok Kr Choudhury
Organizational Affiliation
Institute of Liver and Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Learn more about this trial
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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