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Secondary Prophylaxis of Gastric Variceal Bleed

Primary Purpose

Gastric Varices

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Balloon-occluded retrograde transvenous obliteration
Endoscopic cyanoacrylate injection
N-butyl-2-cyanoacrylate
Lauromacrogol
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Varices

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Cirrhosis
  2. Patients who had bled from GOV2 or IGV1（≥5 days and ≤ 28days）
  3. Presence of gastrorenal shunt

Exclusion Criteria:

  1. Previous treatment of gastric varices, including endoscopic therapy, NSBB, TIPS, or surgery
  2. Non-cirrhotic portal hypertension
  3. Contraindications to cyanoacrylate injection or BRTO
  4. Portal cavernoma
  5. Hepatorenal syndrome
  6. Proven malignancy including hepatocellular carcinoma
  7. End-stage renal disease under renal replacement therapy;
  8. Cardiorespiratory failure
  9. Pregnancy or patients not giving informed consent for endoscopic procedures

Sites / Locations

  • West China Hospital

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 in the gastric varix

Outcomes

Primary Outcome Measures

Rebleeding 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

First Posted
June 3, 2015
Last Updated
January 7, 2019
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02468206
Brief Title
Secondary Prophylaxis of Gastric Variceal Bleed
Official Title
Endoscopic Cyanoacrylate Injection vs. Balloon-occluded Retrograde Transvenous Obliteration in the Prevention of Gastric Variceal Rebleeding
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
January 7, 2019 (Actual)

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 rebleeding and improvement in survival.

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
64 (Actual)

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 in the gastric varix
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
Rebleeding 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 who had bled from GOV2 or IGV1（≥5 days and ≤ 28days） Presence of gastrorenal shunt Exclusion Criteria: Previous treatment of gastric varices, including endoscopic therapy, NSBB, TIPS, or surgery 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
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

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Secondary Prophylaxis of Gastric Variceal Bleed

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