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Secondary Prophylaxis of Gastric Variceal Bleed

S

Sichuan University

Status

Completed

Conditions

Gastric Varices

Treatments

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

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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