Clinical trial NCT06589531: Small Diameter TIPS in Patients with Severe Liver Atrophy and Variceal Bleeding
Official title: 6 Mm Shunt Transjugular Intrahepatic Portosystemic Shunt in Patients with Severe Liver Atrophy and Variceal Bleeding:A Prospective Single-center Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Portal Hypertension Related to Cirrhosis
Keywords: Portal hypertension
TIPS
shunt diameter
hepatic encephalopathy
stent patency
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 \&lt;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: Inclusion Criteria:

1. Diagnosed as cirrhosis
2. Previous or present endoscopic diagnosis of esophageal and gastric varices bleeding.
3. Child -Pugh score C (≤13) or MELD≤18.
4. Enhanced image measurement of liver volume ≤1000cm3.
5. Have indications for TIPS treatment.
6. Researchers believe that patients have the ability to comply with the research plan.
7. Sign the informed consent form

Exclusion Criteria:

1. Malignant tumor (including hepatocellular carcinoma) or other diseases that will shorten the life span of patients.
2. Cavernous portal vein
3. Non-cirrhotic portal hypertension (Budd-Chiari syndrome, extrahepatic portal vein obstruction, idiopathic portal hypertension, etc.)
4. Spontaneous dominant hepatic encephalopathy 5 congestive heart failure or severe valvular heart failure

6. Uncontrollable systemic infection or inflammation 7. Severe pulmonary hypertension 8. Severe renal insufficiency (except hepatogenic renal insufficiency) 9. Rapidly progressing liver failure 10. Contrast agent allergy 11. History of liver transplantation or allogeneic organ transplantation 12. Have a history of TIPS or shunt operation. 13. Pregnancy or lactation 14. Poor compliance 15. Participate in another clinical study.

Primary outcomes:
measure: The 1- year rates of rebleeding
timeFrame: From receiving TIPS to one year after the end of treatment
measure: The 2- year rates of rebleeding
timeFrame: From receiving TIPS to two year after the end of treatment
Secondary outcomes:
measure: The 1- year stent patency rates
timeFrame: From receiving TIPS to 1 year after the end of treatment
measure: The 2- year stent patency rates
timeFrame: From receiving TIPS to 2 year after the end of treatment
measure: The 1-year cumulative incidences of overt HE
timeFrame: From receiving TIPS to 1 year after the end of treatment
measure: The 2-year cumulative incidences of overt HE
timeFrame: From receiving TIPS to 2 year after the end of treatment
Other outcomes:
Locations:
Study officials:
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