Refractory Ascites Clinical Trial
— TIPSOfficial title:
Early TIPS Improve Survival in Patients With Cirrhosis and Recurrent Ascites: a Multicenter Observational Study
| Verified date | March 2024 |
| Source | Tang-Du Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Currently, there is limited evidence regarding the survival benefit of early transjugular intrahepatic portal shunt (TIPS) placement in patients with cirrhosis and recurrent ascites. This observational study aimed to assess whether early TIPS improves the survival of patients with advanced cirrhosis and recurrent ascites. We will compare large volume paracenteses plus albumin (LVP+A） to see if TIPS improves the survival of patients with advanced cirrhosis and recurrent ascites.
| Status | Completed |
| Enrollment | 432 |
| Est. completion date | February 1, 2024 |
| Est. primary completion date | February 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: Definite diagnosis of recurrent ascites in cirrhosis (based on clinical symptoms, laboratory and imaging studies, or liver biopsy) TIPS or LVP+A therapy, - Exclusion Criteria: Malignant neoplasm, including hepatocellular carcinoma with extrahepatic metastasis Prior liver transplantation Severe heart and lung dysfunction Recurrent hepatic encephalopathy Concomitant active infection TIPS with the use of uncovered stents Other causes (upper gastrointestinal bleeding within 2 weeks) Loss to follow-up. - |
| Country | Name | City | State |
|---|---|---|---|
| China | Tangdu hospital | Xian | Shaanxi |
| China | Xi'an International Medical Center Hospital | Xian | Shaanxi |
| China | Xijing hospital | Xian | Shaanxi |
| Lead Sponsor | Collaborator |
|---|---|
| Tang-Du Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | One year transplant free survival | One year |
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