Effectiveness and Safety of TIPS Stent Graft in the Treatment of Cirrhosis and Complications of P… (NCT06669806) | Clinical Trial Compass
RecruitingNot Applicable
Effectiveness and Safety of TIPS Stent Graft in the Treatment of Cirrhosis and Complications of Portal Hypertension
China166 participantsStarted 2024-11-21
Plain-language summary
This Study is a prospective, multi-center, single-arm objective perform an criteria (OPC) study. A 12 months follow-up study on the patients who intend to receive the treatment of cirrhosis and complications of portal hypertension with the TIPS Stent Graft will be conducted. The primary evaluation endpoint of this Study is the stent patency at 6 months after treatment completion .
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. The subject who is 18 years old or above but 75 years old or below;
✓. The subject who is diagnosed with portal hypertension caused by liver cirrhosis with the history of gastrointestinal variceal bleeding or bleeding, hepatic hydrothorax, and refractory or recurrent ascites;
✓. The subject must have adequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of ≤13 or Child-Pugh Score of ≤18;
✓. The subject with platelet count≥ 20×10\^9 /L;
✓. Subjects or their guardians who can understand the content of the clinical trial, voluntarily participate in the clinical trial and sign the ICF and can complete the follow-up period according to the requirements of the clinical trial.
Exclusion criteria
✕. The subject who is pregnant or lactating or plan to get pregnant during the clinical trial;
✕. According to the judgment of investigator, the subject with main portal vein thrombosis which thrombus occupying \>50% of the portal vein lumen and affecting postoperative hemodynamics;
✕. The subject who has received surgical or interventional treatment (such as TIPS, surgical shunt and retrograde transvenous obliteration (-RTO) for treatment of complications from portal hypertension. Note: The subject who have received -RTO for variceal bleeding at least 8 weeks before signing the informed consent form can be included in the clinical trial;
✕. The subject who needs to receive or have received splenectomy;
. The subject who has received or plan to receive liver transplantation;
✕. The subject who cannot have a shunt channel established in the liver parenchyma between the hepatic vein and the portal vein as determined by the investigators;
✕. The subject with extrahepatic or hepatic malignancies;
✕. The subject with Budd-Chiari syndrome and hepatic sinusoidal obstruction syndrome;