Small Diameter TIPS in Patients with Severe Liver Atrophy and Variceal Bleeding

Brief summary (registry, in English)

Portal hypertension is the most common complication in patients with end-stage liver cirrhosis. Portal hypertension-related complications, such as variceal bleeding, often lead to a poor prognosis. Transjugular intrahepatic portosystemic shunt (TIPS) is an effective treatment strategy for managing portal hypertension-related variceal bleeding. However, the appropriate diameter of the covered stent during the TIPS procedure remains a subject of debate. To date, there is a lack of strong evidence regarding the most suitable covered stent diameter. In theory, a shunt with a larger diameter can result in better stent patency, but it can also lead to reduced liver function and a higher incidence of hepatic encephalopathy (HE) after the TIPS procedure. Therefore, the choice of covered stent diameter needs to consider the factors of shunt efficacy and postoperative liver function. At present, the diameters of TIPS-dedicated stents are typically either 8 or 10 mm. Whether stents with these two diameters can meet all the requirements of TIPS procedures is currently unknown. Different races, cirrhosis etiologies, and liver volumes may require different TIPS diameters. For example, in China, most cases of liver cirrhosis are caused by hepatitis B, resulting in the patient having a smaller liver volume. Therefore, in most Chinese studies, the diameters of TIPS stents are mainly 8 mm. Previous studies have shown that TIPS with an 8-mm covered stent has a shunt effect similar to that of a 10-mm covered stent; however, the incidence of postoperative HE is significantly reduced with an 8-mm stent (27% vs. 43%)14. Nevertheless, an 8-mm covered TIPS still has a high incidence of HE. The residual liver volume is small for patients with severe atrophic cirrhosis of the liver, and whether this necessitates a covered TIPS with a smaller diameter requires further study. However, there is still no dedicated TIPS stent that is \<8 mm in diameter. In this study, we propose an innovative strategy for the creation of a 6-mm shunt to determine if it can achieve a shunt effect similar to that of an 8-mm covered TIPS and reduce the incidence of HE in patients with severe atrophic liver cirrhosis.

What you commit to

• Study type: Interventional
• Planned participants: 120
• From 15 Sept 2024 to the primary completion date, 15 Aug 2027
• No sites listed in no country
• Visits and tests: ask the trial team, the registry does not list them

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Who the study is looking for

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

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