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

NCT06589531 | Not Yet Recruiting FDA Device

• 1 other identifier: II2024-234-02
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Keywords

Portal hypertension; TIPS; shunt diameter; hepatic encephalopathy; stent patency

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• The 1- year stent patency rates

  From receiving TIPS to 1 year after the end of treatment

• The 2- year stent patency rates

  From receiving TIPS to 2 year after the end of treatment

• The 1-year cumulative incidences of overt HE

  From receiving TIPS to 1 year after the end of treatment

• The 2-year cumulative incidences of overt HE

  From receiving TIPS to 2 year after the end of treatment

Study Arms (2)

6-mm shunt TIPS group

EXPERIMENTAL

The diameter of TIPS covered stent is 6mm.

Device: During TIPS operation, shunt diameter or diameter of covered stent

8-mm shunt TIPS

ACTIVE COMPARATOR

The diameter of TIPS covered stent is 8mm.

Device: During TIPS operation, shunt diameter or diameter of covered stent

Interventions

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.

6-mm shunt TIPS group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Have indications for TIPS treatment.
• Researchers believe that patients have the ability to comply with the research plan.
• Sign the informed consent form

You may not qualify if:

• 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
• \. 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.

Sponsors & Collaborators

• Huang Mingsheng: lead

MeSH Terms

Conditions

Hypertension, Portal; Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Huzheng Yan, doctor

CONTACT

8613610176039; yanhzhdr@163.com

Mingsheng Huang, doctor

CONTACT

+8613600004855; huangmsh@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Interventional Radiology

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2024
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): September 15, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR