Primary Prophylaxis of Gastric Variceal Bleed

Sichuan University

Status: Enrolling

Conditions: Gastric Varices

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02468180

BRTO-NBCA-PP

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 bleeding.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 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

Treatment:

Drug: N-butyl-2-cyanoacrylate

Procedure: Endoscopic cyanoacrylate injection