The Impact of Transjugular Intrahepatic Portosystemic Shunt on Recompensation in Patients With Decompensated Liver Cirrhosis

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults with decompensated liver cirrhosis who need a TIPS procedure. TIPS is a shunt placed inside the liver to lower pressure in the liver's veins. The trial studies whether liver function can recover after TIPS.

Életkor

18 to 80 years

Nem

All sexes

A betegség stádiuma

Decompensated liver cirrhosis, meaning complications such as fluid in the belly (ascites), confusion from liver disease, or bleeding veins in the gullet or stomach. People must need TIPS for high pressure in the liver veins caused by cirrhosis, for example bleeding not controlled by endoscopic treatment, or ascites that does not respond to treatment.

Biomarker vagy leletérték

The cause of cirrhosis must be treatable, such as hepatitis B (HBV), hepatitis C (HCV) or alcohol-related liver disease. MELD score must not be above 18.

A részvétel fő kizáró okai

• Compensated cirrhosis without complications at the time of TIPS
• TIPS for high liver vein pressure not caused by cirrhosis, such as Budd-Chiari syndrome
• Cancer such as liver cancer (HCC), kidney cancer or lung cancer before TIPS
• Severe heart or lung problems, severe bleeding disorders, or uncontrolled infection
• Pregnancy or allergy to contrast medium

A regiszter feltételei, szó szerint

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Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

• 18 és 80 év között vagy?IgenNem

Mit akar kideríteni a vizsgálat

The traditional view holds that the natural course of cirrhosis is a unidirectional process, characterized by irreversible progression from the compensated stage to the decompensated stage, and is highly likely to develop further decompensation events or even death. However, a growing body of evidence suggests that the natural course of cirrhosis is not always unidirectional - after the removal of the etiology, the structural and functional changes of the liver may be partially reversed. This understanding has given rise to the concept of "liver recompensation," which has been standardized at the Baveno VII Consensus Conference. Notably, in a cohort of patients with alcohol-related cirrhosis, 18% achieved recompensation, which was significantly associated with a reduction of more than 90% in liver-related mortality. In patients with hepatitis B-related cirrhosis, 6% achieved recompensation after treatment with nucleos(t)ide analogs, with a similar improvement in mortality.

A vizsgálat 2 csoportja

• Recompensation group

  Refers to the group of patients who simultaneously meet the three core criteria of "etiology cure", "resolution of decompensation events" and "sustained improvement of liver function" at 1 year after TIPS creation

• Non-Recompensation Group

  Refers to the group of patients who fail to meet the three core criteria of "etiology cure", "resolution of decompensation events" and "sustained improvement of liver function" at 1 year after TIPS creation.