Acute Gastric Variceal Bleeding: Endoscopic Treatment Versus BRTO

Gastric Varices Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02468167
• Other study ID #: BRTO-NBCA-AB
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Gastric Varices

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