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Acute Gastric Variceal Bleeding: Endoscopic Treatment Versus BRTO

Comparison of Endoscopic Cyanoacrylate Injection Versus Balloon-occluded Retrograde Transvenous Obliteration in the Management of Acute Gastric Variceal Bleeding

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02468167
Enrollment
70
Registered
2015-06-10
Start date
2015-06-30
Completion date
2020-07-31
Last updated
2019-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Varices

Brief summary

The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the management of acute gastric bleeding.

Interventions

PROCEDUREBalloon-occluded retrograde transvenous obliteration

Balloon-occluded retrograde transvenous obliteration

PROCEDUREEndoscopic cyanoacrylate injection

Endoscopic cyanoacrylate injection

DRUGN-butyl-2-cyanoacrylate
DRUGLauromacrogol

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Cirrhosis 2. Active bleeding from gastric varices (GOV2 or IGV1) 3. Presence of gastrorenal shunt

Exclusion criteria

1. Previous pharmacologic therapy combined with endoscopic treatment to prevent rebleeding 2. Previous use of TIPS or surgical shunt 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

Design outcomes

Primary

MeasureTime frame
The number of participants with failure to control acute bleeding or failure to prevent clinically significant variceal rebleeding within 1 year after enrollment1 year

Secondary

MeasureTime frame
Eradication rate of gastric varices3 years
Number of participants with increase or decrease in the size of gastric varices3 years
Number of participants with appearance or worsening of new oesophageal varices3 years
Number of participants with appearance or worsening of portal hypertensive gastropathy3 years
Mortality rate3 years
Number of participants with complication3 years
Average in-hospital stay3 years
Cost of treatment3 years
Number of participants with appearance or worsening of ascites3 years

Countries

China

Contacts

Primary ContactXufeng Luo, MD
luo_xuefeng@yeah.net

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026