Clinical trial NCT06106971: Balloon-occluded Retrograde Transvenous Obliteration for Gastric Variceal Rebleeding
Official title: Balloon-occluded Retrograde Transvenous Obliteration Versus Endoscopic Tissue Glue Injection in the Prevention of Recurrent Gastric Variceal Bleeding
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gastric Varices Bleeding
Liver Decompensation
Keywords: gastric varices bleeding
cyanoacrylate
balloon-occluded retrograde transvenous obliteration
liver decompensation
cirrhosis
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: recurrent gastric variceal bleeding
timeFrame: 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
measure: further liver decompensation
timeFrame: 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
Secondary outcomes:
measure: recurrent upper gastrointestinal bleeding
timeFrame: 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
measure: mortality or liver transplantation
timeFrame: 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
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Wen-Chi Chen, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.