Primary Prophylaxis of Gastric Variceal Bleed

Not Applicable

• Conditions: Gastric Varices
• Interventions: Procedure: Balloon-occluded retrograde transvenous obliteration; Procedure: Endoscopic cyanoacrylate injection; Drug: Lauromacrogol; Drug: N-butyl-2-cyanoacrylate

• Registration Number: NCT02468180
• Lead Sponsor: West China Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-05
• Study First Posted: 2015-06-10
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-20
• Last Update Posted: 2021-11-23
• Primary Completion: 2022-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Cirrhosis
2. Patients with high risk gastric varices (GOV2 or IGV1)
3. Presence of gastrorenal shunt

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BRTO	Balloon-occluded retrograde transvenous obliteration	Balloon-occluded retrograde transvenous obliteration
BRTO	Lauromacrogol	Balloon-occluded retrograde transvenous obliteration
NBCA	Endoscopic cyanoacrylate injection	Endoscopic cyanoacrylate injection
NBCA	N-butyl-2-cyanoacrylate	Endoscopic cyanoacrylate injection

Primary Outcome Measures

Name	Time	Method
Bleeding rate from gastric varices	3 years

Secondary Outcome Measures

Name	Time	Method
Number of participants with appearance or worsening of ascites	3 years
Number of participants with complication	3 years
Eradication rate of gastric varices	3 years
Number of participants with increase or decrease in the size of gastric varices	3 years
Number of participants with appearance or worsening of new oesophageal varices	3 years
Number of participants with appearance or worsening of portal hypertensive gastropathy	3 years
Average in-hospital stay	3 years
Cost of treatment	3 years
Mortality rate	3 years

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China