Portal hypertension and related complications
Conditions
Interventions
Sponsors
Zhongda Hospital Affiliated to Southeast University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Men or non-pregnant and non-lactating women aged between 18 and 75 years; 2. Patients diagnosed with cirrhosis and portal hypertension who meet one of the following criteria: 3. Having gastrointestinal (GI) bleeding or a history of GI bleeding, recurrent ascites, recurrent pleural effusion; 4. Patients with a life expectancy of >1 year; 5. Patients who are able to understand the purpose of the trial, voluntarily participate, sign an informed consent form, and are willing to complete the requisite follow-up evaluations outlined in the trial protocol.
Exclusion criteria
Exclusion criteria: 1. Congestive heart failure or severe valvular cardiac insufficiency; 2. Systemic infection or inflammation that is difficult to control; 3. Severe liver insufficiency (Child-Pugh score >=10 points or MELD score >=12 points); 4. Severe renal insufficiency (creatinine > 199.5umol/L); 5. Patients who are known to be allergic to contrast agents and TIPS-coated stents; 6. Patients who have previously undergone TIPS surgery or proposed liver transplantation; 7. Liver malignancy or polycystic liver disease; 8. Bilirubin > 51.3umol/L; 9. Patients with Booga syndrome, hepatic sinus obstruction syndrome, and biliary tract obstruction and dilatation; 10. Patients with hepatic encephalopathy in comatose stage and coma stage (West Haven standard stage III, stage IV); 11. Coagulation dysfunction (INR > 1.8); 12. Patients who have had myocardial infarction within 3 months before surgery; 13. Stenosis degree of portal vein or hepatic vein > 50%; 14. Patients who cannot establish a portal channel in hepatic parenchyma between hepatic vein and portal vein; 15. Patients requiring or having undergone splenectomy; 16. Participants who have not completed clinical trials of other drugs or devices; 17. Patients deemed unsuitable for the clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The stent patency rate at 12 months postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;Success rate of operation;Clinical success rate;The incidence of major adverse events at 3 and 12 months after surgery;Incidence of secondary intervention 1 month, 3 months, 6 months and 12 months after surgery;All-cause mortality at 1, 3, 6, and 12 months after surgery;Incidence of device defects;Incidence of adverse events, serious adverse events; | — |
Countries
China
Contacts
Public ContactGaojun Teng
Zhongda Hospital Affiliated to Southeast University
Outcome results
None listed