Secondary Prophylaxis of Gastric Variceal Bleed

Sichuan University

Status: Completed

Conditions: Gastric Varices

Treatments: Drug: N-butyl-2-cyanoacrylate; Procedure: Endoscopic cyanoacrylate injection; Drug: Lauromacrogol; Procedure: Balloon-occluded retrograde transvenous obliteration

Study type: Interventional

Funder types: Other

Identifiers

NCT02468206

BRTO-NBCA-SP

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

BRTO

Active Comparator group

Description:

Balloon-occluded retrograde transvenous obliteration

Treatment:

Drug: Lauromacrogol

Procedure: Balloon-occluded retrograde transvenous obliteration

NBCA

Active Comparator group

Description:

Endoscopic Cyanoacrylate injection in the gastric varix

Treatment:

Drug: N-butyl-2-cyanoacrylate

Procedure: Endoscopic cyanoacrylate injection