Primary Prophylaxis of Gastric Variceal Bleed

S

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

  • Cirrhosis
  • Patients with high risk gastric varices (GOV2 or IGV1)
  • Presence of gastrorenal shunt

Exclusion criteria

  • Acute bleed or past history of bleed from gastric varices
  • Previous treatment of gastric varices.
  • Non-cirrhotic portal hypertension
  • Contraindications to cyanoacrylate injection or BRTO
  • Portal cavernoma
  • Hepatorenal syndrome
  • Proven malignancy including hepatocellular carcinoma
  • End-stage renal disease under renal replacement therapy;
  • Cardiorespiratory failure
  • Pregnancy or patients not giving informed consent for endoscopic procedures

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

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

Trial contacts and locations

0

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Central trial contact

Xufeng Luo, MD

Data sourced from clinicaltrials.gov

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