Balloon-occluded Retrograde Transvenous Obliteration for Gastric Variceal Rebleeding
Summary
The goal of this randomized controlled trial is to compare the rebleeding rate in cirhotic patients with gastric variceal bleeding receiving balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection. The main questions it aims to answer are: * Recurrent gastric variceal bleeding * Further decompensation of liver cirrhosis Participants will receive balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection. Researchers will compare balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection to see if the rebleeding rate associated with balloon-occluded retrograde transvenous obliteration is lower than that associated with endoscopic tissue glue injection.
Timeline
- Start
- 2018-06-28
- Primary completion
- 2025-06
- Completion
- 2025-06
Publications
- Background Ryan BM, Stockbrugger RW, Ryan JM. A pathophysiologic, gastroenterologic, and radiologic approach to the management of gastric varices. Gastroenterology. 2004 Apr;126(4):1175-89. doi: 10.1053/j.gastro.2004.01.058.
- Background Sarin SK, Lahoti D, Saxena SP, Murthy NS, Makwana UK. Prevalence, classification and natural history of gastric varices: a long-term follow-up study in 568 portal hypertension patients. Hepatology. 1992 Dec;16(6):1343-9. doi: 10.1002/hep.1840160607.
- Background Rockey DC. Management of gastric varices. Gastroenterology. 2001 Jun;120(7):1875-6; discussion 1876-7. doi: 10.1053/s0016-5085(01)70197-7. No abstract available.
- Background Tripathi D, Therapondos G, Jackson E, Redhead DN, Hayes PC. The role of the transjugular intrahepatic portosystemic stent shunt (TIPSS) in the management of bleeding gastric varices: clinical and haemodynamic correlations. Gut. 2002 Aug;51(2):270-4. doi: 10.1136/gut.51.2.270.
- Background Park JK, Saab S, Kee ST, Busuttil RW, Kim HJ, Durazo F, Cho SK, Lee EW. Balloon-Occluded Retrograde Transvenous Obliteration (BRTO) for Treatment of Gastric Varices: Review and Meta-Analysis. Dig Dis Sci. 2015 Jun;60(6):1543-53. doi: 10.1007/s10620-014-3485-8. Epub 2014 Dec 18.
- Background Tan PC, Hou MC, Lin HC, Liu TT, Lee FY, Chang FY, Lee SD. A randomized trial of endoscopic treatment of acute gastric variceal hemorrhage: N-butyl-2-cyanoacrylate injection versus band ligation. Hepatology. 2006 Apr;43(4):690-7. doi: 10.1002/hep.21145.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | N-butyl-2-cyanoacrylate | Other / unclassified | — | Other |
| Subject | Sodium Tetradecyl Sulfate | Unknown | 3 % | — |