Portal hypertension and its complications
Conditions
Interventions
Experimental group:TIPS surgery was performed using the controllable diameter TIPS covered stent system (Suzhou Meichuang Medical Technology Co., LTD.)
Control group:TIPS surgery was performed using the controllable diameter TIPS covered stent system (W. L. GORE & ASSOCIATES, INC.)
Sponsors
Zhongda Hospital Southeast University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1 Age: 18 to 80 years old (including the boundary value), male or non-pregnant and non-lactating female 2 Patients diagnosed with cirrhotic portal hypertension and meeting one of the following conditions: having a history of gastrointestinal bleeding or a history of ascites or pleural effusion 3 The patient was able to understand the purpose of the trial, voluntarily participate and sign the informed consent form, and was willing to complete the follow-up as required by the trial
Exclusion criteria
Exclusion criteria: 1 Mean pulmonary artery pressure > 45mmHg or left ventricular ejection fraction 11 points 3 MELD score > 16 points 4 Severe renal insufficiency (creatinine > twice the upper limit of normal value) 5 Coagulation dysfunction (INR > 1.8, platelet count < 20×109 /L) 6 It is known that there is an allergy to contrast agents and the constituent materials of the controllable diameter TIPS coated stent system 7 Has undergone TIPS surgery in the past or is scheduled for liver transplantation 8 Malignant liver tumors or polycystic liver disease 9 Patients with combined Budd-Chiari syndrome, hepatic sinusoidal obstruction syndrome, and biliary obstruction and dilation 10 Patients in the drowsiness and coma stages of hepatic encephalopathy (West Haven criteria stage III and stage IV) 11 Thrombosis in the main portal vein accounts for more than 50% of the lumen area 12 Patients whose portal passage cannot be established within the liver parenchyma between the hepatic vein and the portal vein 13 Youdaoplaceholder0 Patients who need to undergo splenectomy or have undergone splenectomy 14 Patients with cavernous degeneration of the portal vein 15 We are currently participating in interventional clinical trials for other drugs or medical devices 16 Youdaoplaceholder0 Patients whom the investigators considered unfit to participate in the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stent patency rate 12 months after the operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;Hemodynamic success rate;Incidence of secondary intervention;Incidence of major adverse events;All-cause mortality;Incidence rate of device defects;Incidence of adverse events, incidence of serious adverse events; | — |
Countries
China
Contacts
Public ContactTeng Gaojun
Zhongda Hospital Southeast University
Outcome results
None listed