TIPS with PTFE covered stents vs paracentesis + albumin infusion for the treatment of refractory ascites in patients with cirrhosis: a randomized trial comparing survival, quality of life and nutritional status.

TIPS with PTFE covered stents vs paracentesis + albumin infusion for the treatment of refractory ascites in patients with cirrhosis: a randomized trial comparing survival, quality of life and nutritional status. - TIPS ascites

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29709

Enrollment

Registered

2007-01-22

Start date

2007-02-21

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

refractory ascites

Interventions

TIPS (Transjugular Intrahepatic Portosystemic Shunt) procedure. Through a vein in the neck, a small tube (a stent) is placed between two veins in the liver to decompress the veins of the liver.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: patients of both sexes, age > 18 and

Exclusion criteria

Exclusion criteria: Child Pugh Score > 12

Design outcomes

Primary

Measure	Time frame
Define survival at one year in patients with liver cirrhosis, complicated by ascites, which is not well controlled by paracentesis, treated by TIPS versus paracentesis with albumin infusion.	—

Secondary

Measure	Time frame
Evaluate the differences between the two treatment options concerning: · Quality of life · Nutritional status · Development of other portal hypertension related complications (digestive bleeding, hepatorenal syndrome, SBP, hepatic encephalopathy)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)