Early Use of TIPS With Polytetrafluoroethylene(PTFE) Covered Stents in Cirrhotic Patients With Refractory Ascites
Early Use of Transjugular Intrahepatic Portosystemic Shunt（TIPS）With Polytetrafluoroethylene(PTFE) Covered Stents in Cirrhotic Patients With Refractory Ascites
1 other identifier
interventional
180
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2017
CompletedFirst Posted
Study publicly available on registry
June 1, 2017
CompletedStudy Start
First participant enrolled
June 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedOctober 25, 2022
October 1, 2022
7.5 years
May 27, 2017
October 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Transplant-free survival
12 months
Secondary Outcomes (5)
Frequency of paracentesis
12 months
Frequency of overt Hepatic Encephalopathy
12 months
Nutritional status
12 months
Quality of life
12 months
Other Liver Disease Complications (Adverse Events)
12 months
Study Arms (2)
TIPS with PTFE
EXPERIMENTALTransjugular Intrahepatic portosystemic shunt with PTFE covered stents
paracentesis
ACTIVE COMPARATORParacentesis with albumine invision
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
the First Affiliated Hospital, Air Force Medical University
Xi'an, Shaanxi, 710032, China
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710032, China
Related Publications (2)
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.
PMID: 27663604BACKGROUNDBai 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.
PMID: 24627607BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guohong Han, PhD&MD
Xi'an International Medical Center Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD&MD
Study Record Dates
First Submitted
May 27, 2017
First Posted
June 1, 2017
Study Start
June 29, 2017
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
October 25, 2022
Record last verified: 2022-10