Phase 4
N=121
Carvedilol as an Adjunct to Endoscopic Cyanoacrylate Injection for Secondary Prophylaxis of Gastric Variceal Bleeding
Esophageal and Gastric Varices
Bottom Line
View on ClinicalTrials.gov: NCT02504723 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Rebleeding From Gastric Varices — 14; 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- carvedilol (Drug); cyanoacrylate (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Kaohsiung Veterans General Hospital.
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rebleeding From Gastric Varices |
14; 21 | — |
| SECONDARY All Upper Gastrointestinal Bleeding |
17; 29 | — |
| SECONDARY All Cause Mortality or Liver Transplantation |
13; 20 | — |
| SECONDARY All Adverse Effects |
32; 9 | — |
Summary
Gastric variceal obturation is the current endoscopic therapy of choice for gastric variceal bleeding but is associated with a high rebleeding rate. Carvedilol is a potent non-selective β-blocker. The role of carvedilol in the prevention of recurrent gastric variceal bleeding is not studied. This study aimed at evaluating the efficacy of carvedilol as an adjunct to gastric variceal obturation in the secondary prophylaxis of gastric variceal bleeding.
Eligibility Criteria
Inclusion Criteria
- Age of 20 to 80 years
- Cirrhotic patients with acute gastric variceal bleeding proven by an endoscopy within 24 h of bleeding
- Stable hemodynamic condition for at least 3 days after cyanoacrylate injection
Exclusion Criteria
- Previous treatment of gastric varices, including endoscopic therapy, transjugular intrahepatic porto-systemic shunt, or surgery
- Contraindications to non-selective beta-blockers or cyanoacrylate injection
- Serum total bilirubin >10 mg/dL
- Grade III/IV hepatic encephalopathy
- Hepato-renal syndrome
- Severe heart failure (NYHA Fc III/IV)
- Chronic kidney disease under renal replacement therapy
- Refractory ascites
- Malignancy other than hepatocellular carcinoma
- Pregnancy
- Pacemaker use
- Refusal to participate
Data sourced from ClinicalTrials.gov (NCT02504723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.