Early Use of TIPS With Polytetrafluoroethylene(PTFE) Covered Stents in Cirrhotic Patients With Refractory Ascites

October 22, 2022 updated by: Guohong Han, Air Force Military Medical University, China

Early Use of Transjugular Intrahepatic Portosystemic Shunt（TIPS）With Polytetrafluoroethylene(PTFE) Covered Stents in Cirrhotic Patients With Refractory Ascites

This multicenter RCT is designed to investigate if TIPS with covered stents improves transplant-free survival for cirrhotic patients with early stage of refractory ascites compared to LVP+albumin during 1 year follow-up period.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Completed
        • the First Affiliated Hospital, Air Force Medical University
      • Xi'an, Shaanxi, China, 710032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of liver cirrhosis
  • Recurrent and refractory ascites
  • Patients with an age between 18 and 65 years old
  • Child-Pugh ≤12
  • Absence of hepatic encephalopathy
  • Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.
  • Patient, or legal authorized representative, is willing to provide written informed consent prior to enrollment in the study

Exclusion Criteria:

  • With more than 6 paracenteses within the last 3 months
  • patients expected to receive transplants within the next 6 months or on waiting list
  • Usual contra-indication for TIPS: congestive heart failure NYHA>III or medical history of pulmonary hypertension, portal vein thrombosis（>50%）, hepatic polycystosis, intra-hepatic bile ducts dilatation
  • Patient has had previous TIPS placement
  • Severe liver dysfunction by: Prothrombin index < 40% or total bilirubin > 50μmol/l
  • Serum creatinine >133μmol/l
  • Severe hyponatremia <125mmol / L
  • Uncontrolled sepsis
  • Gastrointestinal hemorrhage within 6 weeks of randomization
  • Known allergy to albumin
  • Pregnant or breast feeding women
  • Refusal to participate or patient unable to receive informations or to sign written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TIPS with PTFE
Transjugular Intrahepatic portosystemic shunt with PTFE covered stents
Procedure: TIPS
Transjugular intrahepatic portosystemic shunt with covered PTFE
ACTIVE_COMPARATOR: paracentesis
Paracentesis with albumine invision
Procedure: paracentesis
paracentasis plus albumine invision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Transplant-free survival
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 12 months
12 months
Nutritional status
Time Frame: 12 months
12 months
Frequency of paracentesis
Time Frame: 12 months
12 months
Frequency of overt Hepatic Encephalopathy
Time Frame: 12 months
Number of episodes of West Haven grade 2 or greater without precipitating factor
12 months
Other Liver Disease Complications (Adverse Events)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Investigators

  • Principal Investigator: Guohong Han, PhD&MD, Xi'an International Medical Center Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 29, 2017

Primary Completion (ANTICIPATED)

December 31, 2024

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

May 27, 2017

First Submitted That Met QC Criteria

May 29, 2017

First Posted (ACTUAL)

June 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 22, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA-TIPS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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