Balloon-occluded Retrograde Transvenous Obliteration for Gastric Variceal Rebleeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-28

Study Completion Date

2025-06-30

Brief Summary

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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:

* 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.

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Detailed Description

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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.

Conditions

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Gastric Varices Bleeding Liver Decompensation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Balloon-occluded retrograde transvenous obliteration

Information of drug:

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

Group Type EXPERIMENTAL

Sodium tetradecyl sulfate

Intervention Type 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.

Endoscopic cyanoacrylate injection

Information of drug:

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

Group Type ACTIVE_COMPARATOR

Cyanoacrylate

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No