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A prospective randomized controlled study of the effect of multi-layer bare stents on clinical outcomes and long-term outcomes after transjugular intrahepatic portosystemic shunt (TIPS)

A prospective randomized controlled study of the effect of multi-layer bare stents on clinical outcomes and long-term outcomes after transjugular intrahepatic portosystemic shunt (TIPS)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053857
Enrollment
Unknown
Registered
2021-12-01
Start date
2022-01-01
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

portal hypertension

Interventions

Group 2:Multilayer bare stent
Group 3:Covered stent
Group 1:Bare stent

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Be able to understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and be willing to accept the designated follow-up in this trial at a specific time point; 2. Aged 18-75 years (including 18 years old and 75 years old); 3. Patients who are clinically diagnosed with liver cirrhosis and have symptoms of portal hypertension, who are suitable for TIPS treatment; 4. Esophageal and gastric variceal bleeding confirmed by gastroscopy; 5. Moderate to severe ascites; 6. Child-Pugh score of liver function: 7-12 points.

Exclusion criteria

Exclusion criteria: 1. Total bilirubin>60 µmol/L (3.5 mg/dl); 2. Portal vein cavernous change; 3. Uncontrollable systemic infection or sepsis; 4. Those with serious diseases of heart, lung, kidney and other organs, and the expected survival is less than 6 months.

Design outcomes

Primary

MeasureTime frame
Technical successful rate;Bleeding and ascites control rate;TIPS shunt patency rate;Patients survival;

Secondary

MeasureTime frame
Hepatic encephalopathy;Liver function;

Countries

China

Contacts

Public ContactZhang Jianbin

China-Japan Friendship Hospital

15101056760@126.com+86 10 84205256

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026