search
Back to results

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

Primary Purpose

Liver Cirrhoses

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TIPS
paracentesis
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhoses focused on measuring Liver Cirrhosis, Transjugular Intrahepatic Portosystemic shunt, Refractory ascites

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • the First Affiliated Hospital, Air Force Medical University
  • Xi'an International Medical Center HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TIPS with PTFE

paracentesis

Arm Description

Transjugular Intrahepatic portosystemic shunt with PTFE covered stents

Paracentesis with albumine invision

Outcomes

Primary Outcome Measures

Transplant-free survival

Secondary Outcome Measures

Frequency of paracentesis
Frequency of overt Hepatic Encephalopathy
Number of episodes of West Haven grade 2 or greater without precipitating factor
Nutritional status
Quality of life
Other Liver Disease Complications (Adverse Events)

Full Information

First Posted
May 27, 2017
Last Updated
October 22, 2022
Sponsor
Air Force Military Medical University, China
search

1. Study Identification

Unique Protocol Identification Number
NCT03172273
Brief Title
Early Use of TIPS With Polytetrafluoroethylene(PTFE) Covered Stents in Cirrhotic Patients With Refractory Ascites
Official Title
Early Use of Transjugular Intrahepatic Portosystemic Shunt（TIPS）With Polytetrafluoroethylene(PTFE) Covered Stents in Cirrhotic Patients With Refractory Ascites
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2017 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhoses
Keywords
Liver Cirrhosis, Transjugular Intrahepatic Portosystemic shunt, Refractory ascites

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TIPS with PTFE
Arm Type
Experimental
Arm Description
Transjugular Intrahepatic portosystemic shunt with PTFE covered stents
Arm Title
paracentesis
Arm Type
Active Comparator
Arm Description
Paracentesis with albumine invision
Intervention Type
Procedure
Intervention Name(s)
TIPS
Intervention Description
Transjugular intrahepatic portosystemic shunt with covered PTFE
Intervention Type
Procedure
Intervention Name(s)
paracentesis
Intervention Description
paracentasis plus albumine invision
Primary Outcome Measure Information:
Title
Transplant-free survival
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Frequency of paracentesis
Time Frame
12 months
Title
Frequency of overt Hepatic Encephalopathy
Description
Number of episodes of West Haven grade 2 or greater without precipitating factor
Time Frame
12 months
Title
Nutritional status
Time Frame
12 months
Title
Quality of life
Time Frame
12 months
Title
Other Liver Disease Complications (Adverse Events)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guohong Han, MD&PhD
Phone
86-13991969930
Email
13991969930@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Chen, MD&PhD
Phone
86-18710930922
Email
qychenhui@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guohong Han, PhD&MD
Organizational Affiliation
Xi'an International Medical Center Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
the First Affiliated Hospital, Air Force Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Completed
Facility Name
Xi'an International Medical Center Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han
Email
13991969930@126.com
First Name & Middle Initial & Last Name & Degree
Hui Chen, MD, Ph.D
Phone
86-18710930922
Email
qychenhui@163.com
First Name & Middle Initial & Last Name & Degree
Guohong Han, MD,Ph.D

12. IPD Sharing Statement

Citations:
PubMed Identifier
27663604
Citation
Bureau C, Thabut D, Oberti F, Dharancy S, Carbonell N, Bouvier A, Mathurin P, Otal P, Cabarrou P, Peron JM, Vinel JP. Transjugular Intrahepatic Portosystemic Shunts With Covered Stents Increase Transplant-Free Survival of Patients With Cirrhosis and Recurrent Ascites. Gastroenterology. 2017 Jan;152(1):157-163. doi: 10.1053/j.gastro.2016.09.016. Epub 2016 Sep 20. Erratum In: Gastroenterology. 2017 Sep;153(3):870.
Results Reference
background
PubMed Identifier
24627607
Citation
Bai M, Qi XS, Yang ZP, Yang M, Fan DM, Han GH. TIPS improves liver transplantation-free survival in cirrhotic patients with refractory ascites: an updated meta-analysis. World J Gastroenterol. 2014 Mar 14;20(10):2704-14. doi: 10.3748/wjg.v20.i10.2704.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs