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Secondary prevention of varicose vein rebleeding in patients with portal hypertension due to cirrhosis with moderate or severe ascites -- clinical observation of TIPS vs. internal medicine treatment

TIPS for secondary prevention of varicose vein rebleeding in patients with cirrhotic portal hypertension with moderate or severe ascites

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024732
Enrollment
Unknown
Registered
2019-07-25
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-07-29

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

Conditions

Cirrhosis of the liver

Interventions

Sponsors

Nanfang Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Obtain informed consent from subjects; 2. Age: 18-75; 3. Clinically definite diagnosis of cirrhosis; 4. Gastroscopy confirmed esophageal and gastric varicose bleeding (the time for the most recent bleeding to TIPS was more than 5 days); 5. Imaging examination suggested moderate and severe ascites; 6. Child-pugh score of liver function: 7-12

Exclusion criteria

Exclusion criteria: 1. Hepatocellular carcinoma or other intrahepatic and intrahepatic malignant tumors; 2. Poor etiology control of cirrhosis; 3. The TIPS of the common contraindications: congestive heart failure (NYHA classification > III or pulmonary hypertension, polycystic liver, etc. 4. Child-pugh score >13 or 60 mol/L of total bilirubin > (3.5 mg/dl), creatinine >180 mol/L(2.1 mg/dl). 5. Isolated gastric fundus or ectopic varicose vein bleeding; 6. Spontaneous dominant hepatic encephalopathy; 7. Previous or present portal vein thrombosis or buga syndrome; 8. Known coagulation disorders other than cirrhosis; 9. History of peptic ulcer, etc., in the past 6 months; 10. Unstable angina pectoris or myocardial infarction 6 months prior to random allocation; 11. Arrhythmias requiring antiarrhythmic treatment (beta blockers or digoxin may be used); 12. Uncontrolled hypertension (systolic > 150mm, or diastolic > 90mmHg, despite optimal treatment); 13. Have had a liver transplant or liver transplant candidate; 14. History of allotransplantation; 15. history of hemorrhagic stroke; 16. A history of major surgery or significant traumatic injury within 1 year prior to randomization; 17. Any complication that limits the patient's treatment or reduces his or her expectation of survival to less than 12 months; 18. Any disease or condition that is unstable or may endanger patient safety and compliance with the study; 19. Seizures requiring medication; 20. A known history of human immunodeficiency virus (HIV) infection; 21. Substance abuse, medical, psychological or social conditions that may affect the patient's participation in the study or the assessment of the study results; 22. Known allergy to research drugs; 23. Pregnancy or lactation; 24. Poor compliance; 25. Participate in another clinical study; 26. Have a close relationship with the research center, such as close relatives of the researcher, subordinate personnel (such as staff or students of the research center who have access to the research records and CRF data).

Design outcomes

Primary

MeasureTime frame
varicose vein rebleeding rate;

Countries

China

Contacts

Public ContactJianbo Zhao

Department of Interventional Therapy, Nanfang Hospital, Southern Medical University

zhaojianbohgl@163.com+86 13189096901

Outcome results

None listed

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