Refractory AscitesTIPSNCT06196723
Transjugular Intrahepatic Portosystemic Shunts Improve Survival in Patients With Cirrhosis and Recurrent Ascites
An observational study of Refractory Ascites, run by Tang-Du Hospital at 3 sites in China.
Trial summary
Currently, there is limited evidence regarding the survival benefit of early transjugular intrahepatic portal shunt (TIPS) placement in patients with cirrhosis and recurrent ascites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Ascites
- What is being tested?
- transjugular intrahepatic portal shunt
- Type of treatment
- Surgery or procedure
- How many people
- 462 participants
- Where
- 3 sitesChina
- Study dates
- 1 Dec 2023to 1 Feb 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective study included patients with cirrhosis and recurrent ascites who were treated with TIPS or large volume paracenteses plus albumin at 11 tertiary level A hospitals in China
Who may be able to join
- Definite diagnosis of recurrent ascites in cirrhosis (based on clinical symptoms, laboratory and imaging studies, or liver biopsy) TIPS or LVP+A therapy, -
Who cannot join
- Malignant neoplasm, including hepatocellular carcinoma with extrahepatic metastasis Prior liver transplantation Severe heart and lung dysfunction Recurrent hepatic encephalopathy Concomitant active infection TIPS with the use of uncovered stents Complete portal vein thrombosis
- -
Trial locations and contacts
3 sites in 1 country.
China3 sites
Tangdu hospital
Xi'an, Shaanxi, 710000
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710000
Xijing hospital
Xi'an, Shaanxi, 710000
About this study
Official title: TIPS Improve Survival in Patients With Cirrhosis and Recurrent Ascites: a Multicenter Observational Study
Currently, there is limited evidence regarding the survival benefit of early transjugular intrahepatic portal shunt (TIPS) placement in patients with cirrhosis and recurrent ascites. This observational study aimed to assess whether early TIPS improves the survival of patients with advanced cirrhosis and recurrent ascites. We will compare large volume paracenteses plus albumin (LVP+A） to see if TIPS improves the survival of patients with advanced cirrhosis and recurrent ascites.
- Conditions
- Refractory Ascites
- Being tested
- transjugular intrahepatic portal shunt
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transjugular intrahepatic portal shuntProcedure or surgery
TIPS was performed by experienced clinicians in the Gastroenterology/Hepatology Department according to standard operating procedures, utilizing 8 mm or 10 mm expanded polytetrafluoroethylene-covered stents at the discretion of the local physician.
| Study group | Role | What they receive |
|---|---|---|
| TIPS | transjugular intrahepatic portal shunt Receives: Procedure: transjugular intrahepatic portal shunt | |
| LVP+A | large volume paracenteses plus albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
One year transplant free survival
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Dec 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory AscitesStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196723
- Sponsor's protocol ID
- Xijing Hospital
- Acronym
- TIPS
- Status last verified
- Aug 2024
- First submitted
- 25 Dec 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIPS Improve Survival in Patients With Cirrhosis and Recurrent Ascites: a Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT06196723
- Acronym / sponsor ID
- TIPS / Xijing Hospital
- Conditions
- Refractory Ascites
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 9 Jan 2024 (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.
Currently, there is limited evidence regarding the survival benefit of early transjugular intrahepatic portal shunt (TIPS) placement in patients with cirrhosis and recurrent ascites. This observational study aimed to assess whether early TIPS improves the survival of patients with advanced cirrhosis and recurrent ascites. We will compare large volume paracenteses plus albumin (LVP+A） to see if TIPS improves the survival of patients with advanced cirrhosis and recurrent ascites.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIPS | – | Procedure: transjugular intrahepatic portal shunttransjugular intrahepatic portal shunt |
| LVP+A | – | –large volume paracenteses plus albumin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study included patients with cirrhosis and recurrent ascites who were treated with TIPS or large volume paracenteses plus albumin at 11 tertiary level A hospitals in China
Key inclusion criteria (1 listed)
- Definite diagnosis of recurrent ascites in cirrhosis (based on clinical symptoms, laboratory and imaging studies, or liver biopsy) TIPS or LVP+A therapy, -
Key exclusion criteria (2 listed)
- Malignant neoplasm, including hepatocellular carcinoma with extrahepatic metastasis Prior liver transplantation Severe heart and lung dysfunction Recurrent hepatic encephalopathy Concomitant active infection TIPS with the use of uncovered stents Complete portal vein thrombosis
- -
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 |
|---|---|---|
| transjugular intrahepatic portal shuntTIPS was performed by experienced clinicians in the Gastroenterology/Hepatology Department according to standard operating procedures, utilizing 8 mm or 10 mm expanded polytetrafluoroethylene-covered stents at the discretion of the local physician. | Procedure or surgery | TIPS |
Primary outcome
One year transplant free survival
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Ascites, run by Tang-Du Hospital at 3 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One year transplant free survival (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2024.