Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Balloon-occluded Retrograde Transvenous Obliteration Versus Endoscopic Tissue Glue Injection in the Prevention of Recurrent Gastric Variceal Bleeding

ID
Name
VGHKS18-CT6-12
Description
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.
Trial arms
Trial start
2018-06-28
Estimated PCD
2025-06-01
Trial end
2025-06-01
Status
Recruiting
Phase
Early phase I
Treatment
Sodium tetradecyl sulfate
Subjects receive sodium tetradecyl sulfate via balloon-occluded retrograde transvenous obliteration at 3 to 5 days after initial hemostasis of acute gastric variceal bleeding.
Arms:
Balloon-occluded retrograde transvenous obliteration
Cyanoacrylate
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.
Arms:
Endoscopic cyanoacrylate injection
Size
68
Primary endpoint
recurrent gastric variceal bleeding
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
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
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 68, 'type': 'ESTIMATED'}}
Updated at
2023-10-30

1 organization

2 products

2 indications

Organization
Kaohsiung Veterans General Hospital
Product
Sodium tetradecyl sulfate
Indication
Gastric Varices Bleeding
Indication
Decompensated liver disease
Product
Cyanoacrylate