About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed as cirrhosis
Previous or present endoscopic diagnosis of esophageal and gastric varices bleeding.
Child -Pugh score C (≤13) or MELD≤18.
Enhanced image measurement of liver volume ≤1000cm3.
Disqualifiers
Malignant tumor (including hepatocellular carcinoma) or other diseases that will shorten the life span of patients.
Cavernous portal vein
Non-cirrhotic portal hypertension (Budd-Chiari syndrome, extrahepatic portal vein obstruction, idiopathic portal hypertension, etc.)
Spontaneous dominant hepatic encephalopathy 5 congestive heart failure or severe valvular heart failure
Trial design
Parallel
Treatments tested in this trial
During TIPS operation, shunt diameter or diameter of covered stent
DeviceTransjugular 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. Due to the lack of a dedicated 6-mm covered stent, we first released a 6-mm diameter stent (SD Express; Boston Scientific Co., or Luminexx; Bard Medical Division) in the liver parenchymal segment of the shunt, and then released an 8-mm TIPS stent (Viatorr; WL Gore \&amp; Associates) to create a final 6-mm shunt.
During TIPS operation, shunt diameter or diameter of covered stent
DeviceAfter successful puncture, in the 8-mm shunt group, a balloon with a diameter of 6 mm was used to expand the shunt, and then an 8-mm covered stent was implanted (Viatorr; WL Gore \& Associates, Inc.).
Treatment groups
Trial outcomes
Primary outcomes
The 1- year rates of rebleeding
The 2- year rates of rebleeding
Secondary outcomes
The 1- year stent patency rates
During the follow-up, there was no thrombosis in the stent and complications related to portal hypertension caused by stent occlusion.
The 2- year stent patency rates
During the follow-up, there was no thrombosis in the stent and complications related to portal hypertension caused by stent occlusion.
The 1-year cumulative incidences of overt HE
HE greater than or equal to 2
The 2-year cumulative incidences of overt HE
HE greater than or equal to 2
Locations
Sponsors and contacts
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Huang Mingsheng
Lead sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Sponsor institution
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