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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02468167
Other study ID # BRTO-NBCA-AB
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date July 2020

Study information

Verified date January 2019
Source West China Hospital
Contact Xufeng Luo, MD
Email luo_xuefeng@yeah.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date July 2020
Est. primary completion date July 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Balloon-occluded retrograde transvenous obliteration
Balloon-occluded retrograde transvenous obliteration
Endoscopic cyanoacrylate injection
Endoscopic cyanoacrylate injection
Drug:
N-butyl-2-cyanoacrylate

Lauromacrogol


Locations

Country Name City State
China West China Hospital Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The number of participants with failure to control acute bleeding or failure to prevent clinically significant variceal rebleeding within 1 year after enrollment 1 year
Secondary Mortality rate 3 years
Secondary Eradication rate of gastric varices 3 years
Secondary Number of participants with increase or decrease in the size of gastric varices 3 years
Secondary Number of participants with appearance or worsening of new oesophageal varices 3 years
Secondary Number of participants with appearance or worsening of portal hypertensive gastropathy 3 years
Secondary Number of participants with appearance or worsening of ascites 3 years
Secondary Number of participants with complication 3 years
Secondary Average in-hospital stay 3 years
Secondary Cost of treatment 3 years
See also
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