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

Not Applicable

Not yet recruiting

• Conditions: Portal Hypertension Related to Cirrhosis
• Interventions: Device: During TIPS operation, shunt diameter or diameter of covered stent

• Registration Number: NCT06589531
• Lead Sponsor: Huang Mingsheng

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 \<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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-09-07
• Study First Submitted QC: 2024-09-09
• Last Update Submitted: 2024-09-09
• Study First Posted: 2024-09-10
• Last Update Posted: 2024-09-10
• Study Start: 2024-09-15
• Primary Completion: 2027-08-15
• Study Completion: 2028-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

5. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6-mm shunt TIPS group	During TIPS operation, shunt diameter or diameter of covered stent	The diameter of TIPS covered stent is 6mm.
8-mm shunt TIPS	During TIPS operation, shunt diameter or diameter of covered stent	The diameter of TIPS covered stent is 8mm.

Primary Outcome Measures

Name	Time	Method
The 1- year rates of rebleeding	From receiving TIPS to one year after the end of treatment
The 2- year rates of rebleeding	From receiving TIPS to two year after the end of treatment

Secondary Outcome Measures

Name	Time	Method
The 1- year stent patency rates	From receiving TIPS to 1 year after the end of treatment	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	From receiving TIPS to 2 year after the end of treatment	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	From receiving TIPS to 1 year after the end of treatment	HE greater than or equal to 2
The 2-year cumulative incidences of overt HE	From receiving TIPS to 2 year after the end of treatment	HE greater than or equal to 2