Status:
UNKNOWN
The Precise Selection of Stent Diameter for Portal Hypertension Patients With TIPS
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Collaborating Sponsors:
LanZhou University
Conditions:
Compensated Advanced Chronic Liver Disease
Portal Hypertension
Eligibility:
All Genders
18-75 years
Brief Summary
The precise planning of TIPS, especially individual selection of stent diameter, is a hot and difficult topic in the field. We have successfully developed a non-invasive technology to evaluate hepatic...
Detailed Description
Transjugular intrahepatic portosystemic shunt (TIPS) is an effective treatment for portal hypertension related variceal bleeding. The precise planning of TIPS, especially individual selection of stent...
Eligibility Criteria
Inclusion
- Criteria:
- age 18-75 years;
- high-risk treatment failure (e.g.Child-Pugh C or B grade with variceal bleeding);
- conventional drugs and endoscopic treatment of esophageal variceal bleeding are not good;
- End-stage liver disease with variceal bleeding before liver transplantation;
- successful implementation of TIPS;
- good compliance with the requirements formulated by the study;
- with written informed consent.
Exclusion
- Liver transplantation in the past or planning liver transplantation in the 6 months;
- Common TIPS contraindications (e.g.NYHA level 2 of congestive heart failure ,history of pulmonary hypertension, portal vein trunk thrombosis, multiple liver cysts,or intrahepatic bile duct dilatation);
- severe liver dysfunction: prothrombin activity \<40% or bilirubin\> 50μmol / L or Child-Pugh score\> 12;
- history of hepatic encephalopathy;
- serum creatinine\> 133μmol / L;
- severe hyponatremia (blood sodium \<125mmol / L);
- uncontrollable infections;
- allergic to intravenous contrast agent;
- subject refused to participate in the trial or without the ability to participate in informed consent;
- previous history of TIPS treatment;
- any comorbidities or conditions that affect the test results as judged by the investigator.
Key Trial Info
Start Date :
June 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 20 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04421118
Start Date
June 11 2021
End Date
December 20 2024
Last Update
February 16 2023
Active Locations (1)
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1
First Affiliated Hospital of Zhejiang University
Hangzhou, China