Balloon-occluded Retrograde Transvenous Obliteration for Gastric Variceal Rebleeding

NCT06106971 | Unknown Phase 3

• 1 other identifier: VGHKS18-CT6-12
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Varices Bleeding; Liver Decompensation

Keywords

gastric varices bleeding; cyanoacrylate; balloon-occluded retrograde transvenous obliteration; liver decompensation; cirrhosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• recurrent upper gastrointestinal bleeding

  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

• mortality or liver transplantation

  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

Study Arms (2)

Balloon-occluded retrograde transvenous obliteration

EXPERIMENTAL

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

Drug: Sodium tetradecyl sulfate

Endoscopic cyanoacrylate injection

ACTIVE COMPARATOR

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

Drug: Cyanoacrylate

Interventions

Sodium tetradecyl sulfate 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.

Balloon-occluded retrograde transvenous obliteration

Cyanoacrylate 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.

Endoscopic cyanoacrylate injection

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age more than 20 years
• a history of liver cirrhosis
• acute GOV2 or IGV1 bleeding

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

RECRUITING

Related Publications (6)

• 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.

  PMID: 15057756 BACKGROUND

• 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.

  PMID: 1446890 BACKGROUND

• 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.

  PMID: 11375970 BACKGROUND

• 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.

  PMID: 12117893 BACKGROUND

• 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.

  PMID: 25519690 BACKGROUND

• 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.

  PMID: 16557539 BACKGROUND

MeSH Terms

Conditions

Hepatic Insufficiency; Fibrosis

Interventions

Sodium Tetradecyl Sulfate; Cyanoacrylates

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Alcohols; Alcohols; Organic Chemicals; Alkanesulfonates; Alkanesulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Lipids; Acrylates; Acids, Acyclic; Carboxylic Acids; Nitriles; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Tissue Adhesives; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Wen-Chi Chen, M.D

  Kaohsiung Veterans General Hospital.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-Chi Chen, M.D

CONTACT

+886 (07) 3468016; wcchen@vghks.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 30, 2023
• Study Start: June 28, 2018
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement. For more information or to submit a request, please contact wcchen@vghks.gov.tw.

Locations

TW (1)