Transjugular Intrahepatic Portosystemic Shunts Improve Survival in Patients With Cirrhosis and Recurrent Ascites (TIPS)

TIPS Improve Survival in Patients With Cirrhosis and Recurrent Ascites: a Multicenter Observational Study

Currently, there is limited evidence regarding the survival benefit of early transjugular intrahepatic portal shunt (TIPS) placement in patients with cirrhosis and recurrent ascites. This observational study aimed to assess whether early TIPS improves the survival of patients with advanced cirrhosis and recurrent ascites. We will compare large volume paracenteses plus albumin (LVP+A） to see if TIPS improves the survival of patients with advanced cirrhosis and recurrent ascites.

Study Overview

• Status: Completed
• Conditions: Refractory Ascites
• Intervention / Treatment: Procedure: transjugular intrahepatic portal shunt

• Study Type: Observational
• Enrollment (Actual): 462

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xian, Shaanxi, China, 710000
      • Tangdu Hospital
    • Xian, Shaanxi, China, 710000
      • Xijing Hospital
    • Xian, Shaanxi, China, 710000
      • Xi'an International Medical Center Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This retrospective study included patients with cirrhosis and recurrent ascites who were treated with TIPS or large volume paracenteses plus albumin at 11 tertiary level A hospitals in China

Description

Inclusion Criteria:

Definite diagnosis of recurrent ascites in cirrhosis (based on clinical symptoms, laboratory and imaging studies, or liver biopsy) TIPS or LVP+A therapy, -

Exclusion Criteria:

Malignant neoplasm, including hepatocellular carcinoma with extrahepatic metastasis Prior liver transplantation Severe heart and lung dysfunction Recurrent hepatic encephalopathy Concomitant active infection TIPS with the use of uncovered stents Complete portal vein thrombosis

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LVP+A; large volume paracenteses plus albumin
TIPS; transjugular intrahepatic portal shunt	Procedure: transjugular intrahepatic portal shunt; TIPS was performed by experienced clinicians in the Gastroenterology/Hepatology Department according to standard operating procedures, utilizing 8 mm or 10 mm expanded polytetrafluoroethylene-covered stents at the discretion of the local physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
One year transplant free survival	One year

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: December 25, 2023
• First Submitted That Met QC Criteria: December 25, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 25, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ascites
• Other Study ID Numbers: Xijing Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No