A Phase 3 interventional study of Sodium tetradecyl sulfate and Cyanoacrylate in Gastric Varices Bleeding and Liver Decompensation, sponsored by Kaohsiung Veterans General Hospital.. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-10-30.
Sponsored by Kaohsiung Veterans General Hospital. · Phase 3, Interventional, and Treatment
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.
329 studies on the registry are indexed under Hepatic Insufficiency; 53 are open to participants now.
This study's planned enrollment of 68 is above the median of 36 across 222 interventional studies indexed under Hepatic Insufficiency.
Browse Hepatic Insufficiency studies →Kaohsiung Veterans General Hospital. is the lead sponsor of 106 studies on the registry; 12 are open to participants now.
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Information of drug: 3% sodium tetradecyl sulfate injection Name: Fibro-vein injection Manufacturer: STD Pharmaceutical Products Ltd.
Drug: Sodium tetradecyl sulfate
Information of drug: N-butyl-2-cyanoacrylate Name: Histoacryl blue Manufacturer: Braun, Melsungen, Germany
Drug: Cyanoacrylate
Subjects receive sodium tetradecyl sulfate via balloon-occluded retrograde transvenous obliteration at 3 to 5 days after initial hemostasis of acute gastric variceal bleeding.
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.
recurrent gastric variceal bleeding
recurrent gastric variceal bleeding after interventions
Time frame: 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
Time frame: 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
recurrent upper gastrointestinal bleeding
recurrent upper gastrointestinal bleeding after interventions
Time frame: 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
mortality or liver transplantation after intervensions
Time frame: 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
Plan to share: Yes — All IPD that underlie results in a publication will be shared 12 months after article publication.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months.
Access criteria: 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.
Started Jun 2018 (actual). Primary completion is estimated for Jun 2025, 84 months after the start.
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This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sodium Tetradecyl Sulfate
Kaohsiung Veterans General Hospital. →