Balloon-occluded Retrograde Transvenous Obliteration for Gastric Variceal Rebleeding

Gastric Varices Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106971
• Other study ID #: VGHKS18-CT6-12
• Status: Recruiting
• Phase: Phase 3
• Start date: June 28, 2018
• Est. completion date: June 2025

Study information

• Verified date: October 2023
• Source: Kaohsiung Veterans General Hospital.
• Contact: Wen-Chi Chen, M.D
• Phone: +886 (07) 3468016
• Email: wcchen[@]vghks.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Gastric Varices Bleeding
• Hemorrhage
• Liver Decompensation
• Liver Failure

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. Erratum In: Hepatology. 2006 Jun;43(6):1410. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrent gastric variceal bleeding	recurrent gastric variceal bleeding after interventions	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
Primary	further liver decompensation	further liver decompensation after intervensions	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	recurrent upper gastrointestinal bleeding	recurrent upper gastrointestinal bleeding after interventions	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
Secondary	mortality or liver transplantation	mortality or liver transplantation after intervensions	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