Liver CirrhosesNCT03172273
Early Use of TIPS With Polytetrafluoroethylene(PTFE) Covered Stents in Cirrhotic Patients With Refractory Ascites
A study testing TIPS and paracentesis in people with Liver Cirrhoses, run by Air Force Military Medical University, China at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Cirrhoses
- What is being tested?
- TIPS and paracentesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesChina
- Study dates
- 29 Jun 2017to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 1 recruiting
- Completed
the First Affiliated Hospital, Air Force Medical University
Xi'an, Shaanxi, 710032
- Recruiting
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710032
Han, 13991969930@126.com
Hui Chen, MD, Ph.D, 86-18710930922, qychenhui@163.com
About this study
Official title: 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.
- Conditions
- Liver Cirrhoses
- Being tested
- TIPS, paracentesis
- Keywords
- Liver Cirrhosis, Transjugular Intrahepatic Portosystemic shunt, Refractory ascites
- Medical subject headings
- Liver Cirrhosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIPSProcedure or surgery
Transjugular intrahepatic portosystemic shunt with covered PTFE
paracentesisProcedure or surgery
paracentasis plus albumine invision
| Study group | Role | What they receive |
|---|---|---|
| TIPS with PTFE | Experimental | Transjugular Intrahepatic portosystemic shunt with PTFE covered stents Receives: Procedure: TIPS |
| paracentesis | Active comparator | Paracentesis with albumine invision Receives: Procedure: paracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant-free survival
Measured: 12 months
Secondary outcomes (5)
Frequency of paracentesis
Measured: 12 months
Frequency of overt Hepatic Encephalopathy
Number of episodes of West Haven grade 2 or greater without precipitating factor
Measured: 12 months
Nutritional status
Measured: 12 months
Quality of life
Measured: 12 months
Other Liver Disease Complications (Adverse Events)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start29 Jun 2017
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohong Han, Xi'an International Medical Center Hospital
- Investigators
- Guohong Han, PhD&MD, Principal investigator, Xi'an International Medical Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172273
- Sponsor's protocol ID
- RA-TIPS
- Status last verified
- Oct 2022
- First submitted
- 27 May 2017
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27663604Bai 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.
PubMed 24627607
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Use of Transjugular Intrahepatic Portosystemic Shunt（TIPS）With Polytetrafluoroethylene(PTFE) Covered Stents in Cirrhotic Patients With Refractory Ascites
- ClinicalTrials.gov ID
- NCT03172273
- Acronym / sponsor ID
- RA-TIPS
- Conditions
- Liver Cirrhoses
- Keywords
- Liver Cirrhosis, Transjugular Intrahepatic Portosystemic shunt, Refractory ascites
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIPS with PTFE | Experimental | Procedure: TIPSTransjugular Intrahepatic portosystemic shunt with PTFE covered stents |
| paracentesis | Active comparator | Procedure: paracentesisParacentesis with albumine invision |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIPSTransjugular intrahepatic portosystemic shunt with covered PTFE | Procedure or surgery | TIPS with PTFE |
| paracentesisparacentasis plus albumine invision | Procedure or surgery | paracentesis |
Primary outcome
Transplant-free survival
Time frame: 12 months
5 secondary outcomes
Frequency of paracentesis
Time frame: 12 months
Frequency of overt Hepatic Encephalopathy
Time frame: 12 months
Nutritional status
Time frame: 12 months
Quality of life
Time frame: 12 months
Other Liver Disease Complications (Adverse Events)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Background: PubMed 27663604Bureau 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.
- Background: PubMed 24627607Bai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guohong Han, PhD&MD principal investigator
Xi'an International Medical Center Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIPS and paracentesis in people with Liver Cirrhoses, run by Air Force Military Medical University, China at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guohong Han, MD&PhD (86-13991969930, 13991969930@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant-free survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03172273, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.