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Randomized and Controlled Trial for the efficacy of interventional devascularization Combination carvedilol versus TIPS Therapy in the prevention of gastric variceal rebleeding in Cirrhotic Patients with Hemodynamic Response to nonselective beta blocker

Randomized and Controlled Trial for the efficacy of interventional devascularization Combination carvedilol versus TIPS Therapy in the prevention of gastric variceal rebleeding in Cirrhotic Patients with Hemodynamic Response to nonselective beta blocker

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027521
Enrollment
Unknown
Registered
2019-11-17
Start date
2019-10-01
Completion date
Unknown
Last updated
2019-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver cirrhosis

Interventions

Group 1:Interventional Devascularization Combination Carvedilol

Sponsors

Xijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Liver cirrhosis diagnosed by clinical examination, imaging or biopsy; 2. Patients with a previous history of variceal hemorrhage; 3. Gastric variceal confirmed by an endoscopic examination, including IGV1 or IGV2; 4. Aged 18 to 75 years; 5. adequate liver and kidney function, including Child-Turcotte-Pugh score < 12, MELD score <19, and serum creatinine less than 2 times the upper limit of normal.

Exclusion criteria

Exclusion criteria: 1. Active variceal bleeding; 2. Esophageal variceal, including GOV1 or GOV2 type, mainly esophageal varices; 3. Refractory ascites; 4. Patients with contraindication to treatment of TIPS, including congestive heart failure, NYHA III and IV, pulmonary arterial hypertension(>50mmHg), polycystic liver, intrahepatic duct dilatation, spontaneous bacterial peritonitis, hepatic encephalopathy; 5. Patients with contraindication to treatment of Carvedilol, including asthma, insulin-dependent diabetes, peripheral vascular diseases; 6. Child-Turcotte-Pugh score >=12, or MELD score >=19; 7. Budd-Chiari syndrome; 8. The main portal vein thrombosis is greater than 50%; 9. Malignancies; 10. An uncontrolled infection; 11. Previously treated with TIPS, splenectomy pericardia vascular disconnection, or surgical shunts; 12. HIV or HIV related illness; 13. Allergic to contrast agent; 14. Lactating or pregnant; 15. Non-compliant patients.

Design outcomes

Primary

MeasureTime frame
No-rebleeding rate;

Secondary

MeasureTime frame
mortality rate related to variceal hemorrhage;Overall survival;Incidence of hepatic encephalopathy;Changes in quality of life;

Countries

China

Contacts

Public ContactTie Jun

Xijing HospitalXijing Hospital, The Air Force Medical University

tiejun7776@163.com+86 18629507963

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026