- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02468180
Primary Prophylaxis of Gastric Variceal Bleed
November 20, 2021 updated by: luo xuefeng, West China Hospital
Primary Prophylaxis of Gastric Variceal Bleed: Endoscopic Cyanoacrylate Injection Versus Balloon-occluded Retrograde Transvenous Obliteration
The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric variceal bleeding.
Study Overview
Status
Recruiting
Conditions
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 Contact
- Name: Xufeng Luo, MD
- Email: luo_xuefeng@yeah.net
Study Locations
-
-
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
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cirrhosis
- Patients with high risk gastric varices (GOV2 or IGV1)
- Presence of gastrorenal shunt
Exclusion Criteria:
- Acute bleed or past history of bleed from gastric varices
- Previous treatment of gastric varices.
- Non-cirrhotic portal hypertension
- Contraindications to cyanoacrylate injection or BRTO
- Portal cavernoma
- Hepatorenal syndrome
- Proven malignancy including hepatocellular carcinoma
- End-stage renal disease under renal replacement therapy;
- Cardiorespiratory failure
- 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
|
Balloon-occluded retrograde transvenous obliteration
|
Active Comparator: NBCA
Endoscopic cyanoacrylate injection
|
Endoscopic cyanoacrylate injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bleeding rate from gastric varices
Time Frame: 3 years
|
3 years
|
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
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, 2022
Study Completion (Anticipated)
July 1, 2022
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)
November 23, 2021
Last Update Submitted That Met QC Criteria
November 20, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRTO-NBCA-PP
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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