Balloon-occluded Retrograde Transvenous Obliteration for Gastric Variceal Rebleeding

Kaohsiung Veterans General Hospital

Status and phase: Enrolling; Phase 3

Conditions: Liver Decompensation; Gastric Varices Bleeding

Treatments: Drug: Sodium tetradecyl sulfate; Drug: Cyanoacrylate

Study type: Interventional

Funder types: Other

Identifiers

NCT06106971

VGHKS18-CT6-12

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Balloon-occluded retrograde transvenous obliteration

Experimental group

Description:

Information of drug: 3% sodium tetradecyl sulfate injection Name: Fibro-vein injection Manufacturer: STD Pharmaceutical Products Ltd.

Treatment:

Drug: Sodium tetradecyl sulfate

Endoscopic cyanoacrylate injection

Active Comparator group

Description:

Information of drug: N-butyl-2-cyanoacrylate Name: Histoacryl blue Manufacturer: Braun, Melsungen, Germany

Treatment:

Drug: Cyanoacrylate