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

NCT ID: NCT06589531

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2028-09-15

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.

Conditions

Portal Hypertension Related to Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

6-mm shunt TIPS group

The diameter of TIPS covered stent is 6mm.

Group Type: EXPERIMENTAL

During TIPS operation, shunt diameter or diameter of covered stent

Intervention Type: 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.

8-mm shunt TIPS

The diameter of TIPS covered stent is 8mm.

Group Type: ACTIVE_COMPARATOR

During TIPS operation, shunt diameter or diameter of covered stent

Intervention Type: 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.).

Interventions

During TIPS operation, shunt diameter or diameter of covered stent

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.

Intervention Type: DEVICE

During TIPS operation, shunt diameter or diameter of covered stent

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.).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huang Mingsheng

OTHER

Sponsor Role: lead

Responsible Party

Huang Mingsheng

Director of Interventional Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Huzheng Yan, doctor

Role: CONTACT

yanhzhdr@163.com

8613610176039 ext. 131610176039

Mingsheng Huang, doctor

Role: CONTACT

huangmsh@mail.sysu.edu.cn

+8613600004855

Other Identifiers

II2024-234-02

Identifier Type: -

Identifier Source: org_study_id