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

NCT ID: NCT06196723

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

462 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Refractory Ascites

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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TIPS

transjugular intrahepatic portal shunt

transjugular intrahepatic portal shunt

Intervention Type PROCEDURE

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.

LVP+A

large volume paracenteses plus albumin

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tang-Du Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tangdu hospital

Xi'an, Shaanxi, China

Site Status

Xi'an International Medical Center Hospital

Xi'an, Shaanxi, China

Site Status

Xijing hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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Xijing Hospital

Identifier Type: -

Identifier Source: org_study_id

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