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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHuang Mingsheng

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • During TIPS operation, shunt diameter or diameter of covered stent

    Device

    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. 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 \& Associates) to create a final 6-mm shunt.

  • During TIPS operation, shunt diameter or diameter of covered stent

    Device

    After 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

120 Participants
are divided into 2 treatment groups
Group A: 6-mm shunt TIPS groupExperimental treatment 1 intervention
Group B: 8-mm shunt TIPSActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The 1- year rates of rebleeding

Time frame
From receiving TIPS to one year after the end of treatment
2

The 2- year rates of rebleeding

Time frame
From receiving TIPS to two year after the end of treatment

Secondary outcomes

1

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.

Time frame
From receiving TIPS to 1 year after the end of treatment
2

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.

Time frame
From receiving TIPS to 2 year after the end of treatment
3

The 1-year cumulative incidences of overt HE

HE greater than or equal to 2

Time frame
From receiving TIPS to 1 year after the end of treatment
4

The 2-year cumulative incidences of overt HE

HE greater than or equal to 2

Time frame
From receiving TIPS to 2 year after the end of treatment

Other outcomes

Locations

This trial has no 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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