Back to resultsPrimary Prophylaxis of Gastric Variceal Bleed
Primary Purpose
Gastric Varices
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Balloon-occluded retrograde transvenous obliteration
Endoscopic cyanoacrylate injection
N-butyl-2-cyanoacrylate
Lauromacrogol
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Varices
Eligibility Criteria
Inclusion Criteria:
- Cirrhosis
- Patients with high risk gastric varices (GOV2 or IGV1)
- Presence of gastrorenal shunt
Exclusion Criteria:
- Acute bleed or past history of bleed from gastric varices
- Previous treatment of gastric varices.
- Non-cirrhotic portal hypertension
- Contraindications to cyanoacrylate injection or BRTO
- Portal cavernoma
- Hepatorenal syndrome
- Proven malignancy including hepatocellular carcinoma
- End-stage renal disease under renal replacement therapy;
- Cardiorespiratory failure
- Pregnancy or patients not giving informed consent for endoscopic procedures
Sites / Locations
- West China HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
BRTO
NBCA
Arm Description
Balloon-occluded retrograde transvenous obliteration
Endoscopic cyanoacrylate injection
Outcomes
Primary Outcome Measures
Bleeding rate from gastric varices
Secondary Outcome Measures
Eradication rate of gastric varices
Number of participants with increase or decrease in the size of gastric varices
Number of participants with appearance or worsening of new oesophageal varices
Number of participants with appearance or worsening of portal hypertensive gastropathy
Number of participants with appearance or worsening of ascites
Number of participants with complication
Average in-hospital stay
Cost of treatment
Mortality rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02468180
Brief Title
Primary Prophylaxis of Gastric Variceal Bleed
Official Title
Primary Prophylaxis of Gastric Variceal Bleed: Endoscopic Cyanoacrylate Injection Versus Balloon-occluded Retrograde Transvenous Obliteration
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 2015 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric variceal bleeding.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Varices
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BRTO
Arm Type
Active Comparator
Arm Description
Balloon-occluded retrograde transvenous obliteration
Arm Title
NBCA
Arm Type
Active Comparator
Arm Description
Endoscopic cyanoacrylate injection
Intervention Type
Procedure
Intervention Name(s)
Balloon-occluded retrograde transvenous obliteration
Intervention Description
Balloon-occluded retrograde transvenous obliteration
Intervention Type
Procedure
Intervention Name(s)
Endoscopic cyanoacrylate injection
Intervention Description
Endoscopic cyanoacrylate injection
Intervention Type
Drug
Intervention Name(s)
N-butyl-2-cyanoacrylate
Intervention Type
Drug
Intervention Name(s)
Lauromacrogol
Primary Outcome Measure Information:
Title
Bleeding rate from gastric varices
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Eradication rate of gastric varices
Time Frame
3 years
Title
Number of participants with increase or decrease in the size of gastric varices
Time Frame
3 years
Title
Number of participants with appearance or worsening of new oesophageal varices
Time Frame
3 years
Title
Number of participants with appearance or worsening of portal hypertensive gastropathy
Time Frame
3 years
Title
Number of participants with appearance or worsening of ascites
Time Frame
3 years
Title
Number of participants with complication
Time Frame
3 years
Title
Average in-hospital stay
Time Frame
3 years
Title
Cost of treatment
Time Frame
3 years
Title
Mortality rate
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cirrhosis
Patients with high risk gastric varices (GOV2 or IGV1)
Presence of gastrorenal shunt
Exclusion Criteria:
Acute bleed or past history of bleed from gastric varices
Previous treatment of gastric varices.
Non-cirrhotic portal hypertension
Contraindications to cyanoacrylate injection or BRTO
Portal cavernoma
Hepatorenal syndrome
Proven malignancy including hepatocellular carcinoma
End-stage renal disease under renal replacement therapy;
Cardiorespiratory failure
Pregnancy or patients not giving informed consent for endoscopic procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xufeng Luo, MD
Email
luo_xuefeng@yeah.net
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuefeng Luo, MD
Phone
862885422389
12. IPD Sharing Statement
Learn more about this trial
Primary Prophylaxis of Gastric Variceal Bleed
We'll reach out to this number within 24 hrs