Acute Gastric Variceal Bleeding: Endoscopic Treatment Versus BRTO

January 7, 2019 updated by: luo xuefeng, West China Hospital

Comparison of Endoscopic Cyanoacrylate Injection Versus Balloon-occluded Retrograde Transvenous Obliteration in the Management of Acute Gastric Variceal Bleeding

The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the management of acute gastric bleeding.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital
        • Contact:
          • Xuefeng Luo, MD
          • Phone Number: 862885422389

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Cirrhosis
  2. Active bleeding from gastric varices (GOV2 or IGV1)
  3. Presence of gastrorenal shunt

Exclusion Criteria:

  1. Previous pharmacologic therapy combined with endoscopic treatment to prevent rebleeding
  2. Previous use of TIPS or surgical shunt
  3. Non-cirrhotic portal hypertension
  4. Contraindications to cyanoacrylate injection or BRTO
  5. Portal cavernoma
  6. Hepatorenal syndrome
  7. Proven malignancy including hepatocellular carcinoma
  8. End-stage renal disease under renal replacement therapy;
  9. Cardiorespiratory failure
  10. Pregnancy or patients not giving informed consent for endoscopic procedures

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BRTO
Balloon-occluded retrograde transvenous obliteration
Procedure: Balloon-occluded retrograde transvenous obliteration
Balloon-occluded retrograde transvenous obliteration
Drug: Lauromacrogol
Active Comparator: NBCA
Endoscopic cyanoacrylate injection
Procedure: Endoscopic cyanoacrylate injection
Endoscopic cyanoacrylate injection
Drug: N-butyl-2-cyanoacrylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of participants with failure to control acute bleeding or failure to prevent clinically significant variceal rebleeding within 1 year after enrollment
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Eradication rate of gastric varices
Time Frame: 3 years
3 years
Number of participants with increase or decrease in the size of gastric varices
Time Frame: 3 years
3 years
Number of participants with appearance or worsening of new oesophageal varices
Time Frame: 3 years
3 years
Number of participants with appearance or worsening of portal hypertensive gastropathy
Time Frame: 3 years
3 years
Number of participants with appearance or worsening of ascites
Time Frame: 3 years
3 years
Number of participants with complication
Time Frame: 3 years
3 years
Average in-hospital stay
Time Frame: 3 years
3 years
Cost of treatment
Time Frame: 3 years
3 years
Mortality rate
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

West China Hospital

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 1, 2015

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

June 5, 2015

First Posted (Estimate)

June 10, 2015

Study Record Updates

Last Update Posted (Actual)

January 8, 2019

Last Update Submitted That Met QC Criteria

January 7, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRTO-NBCA-AB

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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