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Acute Gastric Variceal Bleeding: Endoscopic Treatment Versus BRTO

Primary Purpose

Gastric Varices

Status
Unknown status
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. Active bleeding from gastric varices (GOV2 or IGV1)
  3. Presence of gastrorenal shunt

Exclusion Criteria:

  1. Previous pharmacologic therapy combined with endoscopic treatment to prevent rebleeding
  2. Previous use of TIPS or surgical shunt
  3. Non-cirrhotic portal hypertension
  4. Contraindications to cyanoacrylate injection or BRTO
  5. Portal cavernoma
  6. Hepatorenal syndrome
  7. Proven malignancy including hepatocellular carcinoma
  8. End-stage renal disease under renal replacement therapy;
  9. Cardiorespiratory failure
  10. 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

The number of participants with failure to control acute bleeding or failure to prevent clinically significant variceal rebleeding within 1 year after enrollment

Secondary Outcome Measures

Mortality rate
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

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
NCT02468167
Brief Title
Acute Gastric Variceal Bleeding: Endoscopic Treatment Versus BRTO
Official Title
Comparison of Endoscopic Cyanoacrylate Injection Versus Balloon-occluded Retrograde Transvenous Obliteration in the Management of Acute Gastric Variceal Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Data Monitoring Committee
No

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 management of acute gastric 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
The number of participants with failure to control acute bleeding or failure to prevent clinically significant variceal rebleeding within 1 year after enrollment
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Mortality rate
Time Frame
3 years
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

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 Active bleeding from gastric varices (GOV2 or IGV1) Presence of gastrorenal shunt Exclusion Criteria: Previous pharmacologic therapy combined with endoscopic treatment to prevent rebleeding Previous use of TIPS or surgical shunt 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

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Acute Gastric Variceal Bleeding: Endoscopic Treatment Versus BRTO

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