Balloon-occluded Retrograde Transvenous Obliteration for Gastric Variceal Rebleeding

October 24, 2023 updated by: Wen-Chi Chen, Kaohsiung Veterans General Hospital.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Recruiting
        • Kaohsiung Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Wen-Chi Chen, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Balloon-occluded retrograde transvenous obliteration

Information of drug:

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

Information of drug:

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrent gastric variceal bleeding
Time Frame: 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
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
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrent upper gastrointestinal bleeding
Time Frame: 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
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
mortality or liver transplantation
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Investigators

  • Principal Investigator: Wen-Chi Chen, M.D, Kaohsiung Veterans General Hospital.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2018

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGHKS18-CT6-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication will be shared 12 months after article publication.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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