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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:
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.
Variceal bleeding is a severe complication of portal hypertension. Gastric variceal bleeding (GVB) is more severe than bleeding from esophageal varices. Gastric varices also have a higher risk of rebleeding than esophageal varices. Previous studies showed that endoscopic injection of cyanoacrylate was superior to endoscopic variceal ligation in the management of gastric variceal bleeding. Another study showed that transjugular intrahepatic portosystemic shunt had a lower rebleeding rate than endoscopic cyanoacrylate injection. However, transjugular intrahepatic portosystemic shunt (TIPS) is more invasive and carries a risk of development of hepatic encephalopathy and is usually preserved for uncontrolled variceal bleeding. Therefore, endoscopic cyanoacrylate injection is recommended as the treatment of choice for GVB. Balloon-occluded retrograde transvenous obliteration (BRTO) is a new therapy for gastric variceal bleeding. However, BRTO is associated with increased portal pressure and worsening of ascites, hepatohydrothorax, and esophageal varices. There are only a few retrospective studies comparing BRTO and endoscopic cyanoacrylate injection in the prevention of recurrent gastric variceal bleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balloon-occluded retrograde transvenous obliteration | Experimental | Information of drug: 3% sodium tetradecyl sulfate injection Name: Fibro-vein injection Manufacturer: STD Pharmaceutical Products Ltd. |
|
| Endoscopic cyanoacrylate injection | Active Comparator | Information of drug: N-butyl-2-cyanoacrylate Name: Histoacryl blue Manufacturer: Braun, Melsungen, Germany |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium tetradecyl sulfate | Drug | Subjects receive sodium tetradecyl sulfate via balloon-occluded retrograde transvenous obliteration at 3 to 5 days after initial hemostasis of acute gastric variceal bleeding. |
| Measure | Description | Time Frame |
|---|---|---|
| recurrent gastric variceal bleeding | recurrent gastric variceal bleeding after interventions | From date of randomization until the date of first documented recurrent gastric variceal bleeding or date of death from any cause, whichever comes first, assessed up to 100 months |
| further liver decompensation | further liver decompensation after intervensions | From date of randomization until the date of first documented further liver decompensation or date of death from any cause, whichever comes first, assessed up to 100 months |
| Measure | Description | Time Frame |
|---|---|---|
| recurrent upper gastrointestinal bleeding | recurrent upper gastrointestinal bleeding after interventions | From date of randomization until the date of first documented recurrent upper gastrointestinal bleeding or date of death from any cause, whichever comes first, assessed up to 100 months |
| mortality or liver transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wen-Chi Chen, M.D | Contact | +886 (07) 3468016 | wcchen@vghks.gov.tw |
| Name | Affiliation | Role |
|---|---|---|
| Wen-Chi Chen, M.D | Kaohsiung Veterans General Hospital. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Veterans General Hospital | Recruiting | Kaohsiung City | 813 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15057756 | 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. | |
| 1446890 | 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. |
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All IPD that underlie results in a publication will be shared 12 months after article publication.
Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months.
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement. For more information or to submit a request, please contact wcchen@vghks.gov.tw.
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012981 | Sodium Tetradecyl Sulfate |
| D003487 | Cyanoacrylates |
| ID | Term |
|---|---|
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000476 | Alkanesulfonates |
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| Cyanoacrylate | Drug | Subjects receive endoscopic cyanoacrylate injection at 3 to 5 days after initial hemostasis of acute gastric variceal bleeding then receive repeated endoscopic cyanoacrylate injection at 1-month intervals until obliteration of gastric varices. |
|
mortality or liver transplantation after intervensions |
| From date of randomization until the date of documented liver transplantation or date of death from any cause, whichever comes first, assessed up to 100 months |
| 11375970 | 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. |
| 12117893 | 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. |
| 25519690 | 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. |
| 16557539 | 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. |
| D017738 |
| Alkanesulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D008055 | Lipids |
| D000179 | Acrylates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009570 | Nitriles |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D014014 | Tissue Adhesives |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |