Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576934
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Early TIPS in Patients With Liver Cirrhosis and Ascites
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Early Implantation of a Transjugular Intrahepatic Portosystemic Shunt TIPS in Patients With Liver Cirrhosis and Ascites a Multicentre Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eTIPS
Brief Summary:
The aim of this clinical trial is to compare the safety and efficacy of transjugular intrahepatic portosystemic shunt TIPS implantation with standard treatment diuretic medications and if necessary paracenteses in patients with liver cirrhosis and development of ascites as the first decompensating event
By creating a shunt between the liver vein and the portal vein blood is diverted from the portal vein directly into the hepatic vein which results in a reduction of pressure in the portal vein so that development of ascites is reduced
By creating a shunt between the liver vein and the portal vein blood is diverted from the portal vein directly into the hepatic vein which results in a reduction of pressure in the portal vein so that development of ascites is reduced
Detailed Description:
Complications in patients with liver cirrhosis are mainly due to the development of clinical significant portal hypertension These complications include development of varices and ascites Implantation of a transjugular intrahepatic portosystemic shunt TIPS has emerged as a safe and effective interventional treatment of portal hypertension TIPS implantation is recommended for secondary prophylaxis of variceal bleeding Further in patients with acute variceal bleeding early TIPS implantation within 72 hours after the bleeding episode is associated with a lower re-bleeding rate and also improved survival in high risk patients In patients with ascites TIPS implantation is recommend in more advanced stages when conservative treatment has failed to control ascites Importantly ascites clearance can be achieved in only 51 in these patients Recently it has been shown that patients with a lower paracenteses frequency have a higher chance of ascites control compared to patients with long-term paracenteses These data suggest that TIPS implantation in patients with ascites should not be delayed comparable to patients with acute variceal bleeding The presented study aims to analyse the concept of early TIPS implantation in patients with liver cirrhosis and ascites
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None