Treatment for gastric variceal bleeding using balloon-occluded retrograde transvenous obliteration
Balloon-occluded Retrograde Transvenous Obliteration Versus Endoscopic Tissue Glue Injection in the Prevention of Recurrent Gastric Variceal Bleeding
This study is testing whether a new treatment called balloon-occluded retrograde transvenous obliteration (BRTO) can help cirrhotic patients with gastric variceal bleeding have fewer rebleeding episodes compared to the standard glue injection treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Kaohsiung Veterans General Hospital. Academic / other |
| Locations | 1 site (Kaohsiung) |
| Trial ID | NCT06106971 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of balloon-occluded retrograde transvenous obliteration (BRTO) against endoscopic tissue glue injection in preventing rebleeding in cirrhotic patients with gastric variceal bleeding. Participants will be randomly assigned to receive either BRTO or endoscopic glue injection, and the study will monitor the rates of recurrent bleeding and further liver decompensation. The trial seeks to determine if BRTO can provide a lower rebleeding rate compared to the standard treatment. This approach is particularly important given the severe nature of gastric variceal bleeding and its associated complications.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 20 years old with a history of liver cirrhosis and acute gastric variceal bleeding.
Not a fit: Patients with previous treatments for gastric varices, active malignancies, or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of rebleeding in patients with gastric varices, improving their overall health outcomes.
How similar studies have performed: Previous studies have shown promising results for endoscopic cyanoacrylate injection, but the use of BRTO in this context is relatively novel and less tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age more than 20 years * a history of liver cirrhosis * acute GOV2 or IGV1 bleeding Exclusion Criteria: * previous treatment for gastric varices, including endoscopic therapy, transjugular intrahepatic portosystemic shunt, or shunt surgery * hepatocellular carcinoma or other malignancy * stroke, uremia, or active sepsis * serum total bilirubin \>10 mg/dL * grade III/IV hepatic encephalopathy * refractory ascites * uncontrolled index bleeding * pregnancy * severe heart failure (NYHA Fc III/IV) * allergy to cyanoacrylate, lipiodol, iodine, or sodium tetradecyl sulfate * absence of gastrorenal shunt
Where this trial is running
Kaohsiung
- Kaohsiung Veterans General Hospital — Kaohsiung, Taiwan (Recruiting)
Study contacts
- Principal investigator: Wen-Chi Chen, M.D — Kaohsiung Veterans General Hospital.
- Study coordinator: Wen-Chi Chen, M.D
- Email: wcchen@vghks.gov.tw
- Phone: +886 (07) 3468016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.