Secondary Prophylaxis of Gastric Variceal Bleed

Gastric Varices Clinical Trial

Official title:

Endoscopic Cyanoacrylate Injection vs. Balloon-occluded Retrograde Transvenous Obliteration in the Prevention of Gastric Variceal Rebleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02468206
• Other study ID #: BRTO-NBCA-SP
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: January 7, 2019

Study information

• Verified date: January 2019
• Source: West China Hospital
• Contact: n/a
• 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 prevention of gastric variceal rebleeding and improvement in survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 7, 2019
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Cirrhosis

2. Patients who had bled from GOV2 or IGV1(=5 days and = 28days)

3. Presence of gastrorenal shunt

Exclusion Criteria:

1. Previous treatment of gastric varices, including endoscopic therapy, NSBB, TIPS, or surgery

2. Non-cirrhotic portal hypertension

3. Contraindications to cyanoacrylate injection or BRTO

4. Portal cavernoma

5. Hepatorenal syndrome

6. Proven malignancy including hepatocellular carcinoma

7. End-stage renal disease under renal replacement therapy;

8. Cardiorespiratory failure

9. 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	Rebleeding rate from gastric varices		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
Secondary	Mortality rate		3 years