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

Liver Cirrhoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03172273
• Other study ID #: RA-TIPS
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Air Force Military Medical University, China
• Contact: Guohong Han, MD&PhD
• Phone: 86-13991969930
• Email: 13991969930[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ascites
• Fibrosis
• Liver Cirrhoses
• Liver Cirrhosis

Intervention

Procedure:
• TIPS
Transjugular intrahepatic portosystemic shunt with covered PTFE
• paracentesis
paracentasis plus albumine invision

Locations

Country	Name	City	State
China	the First Affiliated Hospital, Air Force Medical University	Xi'an	Shaanxi
China	Xi'an International Medical Center Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Review. — View Citation

Bureau C, Thabut D, Oberti F, Dharancy S, Carbonell N, Bouvier A, Mathurin P, Otal P, Cabarrou P, Péron 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transplant-free survival		12 months
Secondary	Frequency of paracentesis		12 months
Secondary	Frequency of overt Hepatic Encephalopathy	Number of episodes of West Haven grade 2 or greater without precipitating factor	12 months
Secondary	Nutritional status		12 months
Secondary	Quality of life		12 months
Secondary	Other Liver Disease Complications (Adverse Events)		12 months