Secondary Prophylaxis of Gastric Variceal Bleed

Not Applicable

Completed

• Conditions: Gastric Varices
• Interventions: Procedure: Balloon-occluded retrograde transvenous obliteration; Procedure: Endoscopic cyanoacrylate injection; Drug: Lauromacrogol; Drug: N-butyl-2-cyanoacrylate

• Registration Number: NCT02468206
• Lead Sponsor: West China Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-05
• Study First Posted: 2015-06-10
• Primary Completion: 2018-02-28
• Status Verified: 2019-01
• Study Completion: 2019-01-07
• Last Update Submitted: 2019-01-07
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BRTO	Balloon-occluded retrograde transvenous obliteration	Balloon-occluded retrograde transvenous obliteration
BRTO	Lauromacrogol	Balloon-occluded retrograde transvenous obliteration
NBCA	Endoscopic cyanoacrylate injection	Endoscopic Cyanoacrylate injection in the gastric varix
NBCA	N-butyl-2-cyanoacrylate	Endoscopic Cyanoacrylate injection in the gastric varix

Primary Outcome Measures

Name	Time	Method
Rebleeding rate from gastric varices	3 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China