Acute Gastric Variceal Bleeding: Endoscopic Treatment Versus BRTO

West China Hospital70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gastric Varices

Interventions

Balloon-occluded retrograde transvenous obliterationPROCEDURE

Balloon-occluded retrograde transvenous obliteration

Endoscopic cyanoacrylate injectionPROCEDURE

Endoscopic cyanoacrylate injection

N-butyl-2-cyanoacrylateDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

West China Hospital

Chengdu, Sichuan, China

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

Mortality rate

Time frame: 3 years

Eradication rate of gastric varices

Time frame: 3 years

Number of participants with increase or decrease in the size of gastric varices

Time frame: 3 years

Number of participants with appearance or worsening of new oesophageal varices

Time frame: 3 years

Number of participants with appearance or worsening of portal hypertensive gastropathy

Time frame: 3 years

Number of participants with appearance or worsening of ascites

Time frame: 3 years

Number of participants with complication

Time frame: 3 years

Average in-hospital stay

Time frame: 3 years

Cost of treatment

Time frame: 3 years

Central Contacts

Xufeng Luo, MD

CONTACT

luo_xuefeng@yeah.net

Data from ClinicalTrials.gov

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