Transjugular Intrahepatic Portosystemic Shunts Improve Su... | NCT06196723

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

NCT06196723

Sponsor

Tang-Du Hospital

Status

Completed

Last Update Posted

Aug 27, 2024Actual

Enrollment

462Actual

Phase

Not provided

Conditions

Refractory Ascites

Interventions

transjugular intrahepatic portal shunt

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Actual

Primary Completion Date

Feb 1, 2024Actual

Completion Date

Feb 1, 2024Actual

First Submitted Date

Dec 25, 2023

First Submission Date that Met QC Criteria

Dec 25, 2023

First Posted Date

Jan 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2024

Last Update Posted Date

Aug 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

462Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TIPS		transjugular intrahepatic portal shunt	Procedure: transjugular intrahepatic portal shunt
LVP+A		large volume paracenteses plus albumin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transjugular intrahepatic portal shunt	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.

Measure	Description	Time Frame
One year transplant free survival		One year

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tangdu hospital		Xi'an	Shaanxi	710000	China
Xi'an International Medical Center Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001201	Ascites

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided