Primary Prophylaxis of Gastric Variceal Bleed

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 prevention of gastric variceal 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. Patients with high risk gastric varices (GOV2 or IGV1) 3. Presence of gastrorenal shunt Exclusion Criteria: 1. Acute bleed or past history of bleed from gastric varices 2. Previous treatment of gastric varices. 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

Bleeding rate from gastric varices

Time frame: 3 years

Secondary Outcomes

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

Mortality rate

Time frame: 3 years

Central Contacts

Xufeng Luo, MD

CONTACT

luo_xuefeng@yeah.net

Data from ClinicalTrials.gov

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