Cirrhosis PortalNCT06221982
TIPS for PH Patients: an Observational, Cohort Study
An observational study of Cirrhosis Portal, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
This is a single-center, prospective, observational study intended to include patients receiving TIPS for portal hypertension. Baseline data of enrolled patients were recorded, and samples of ascites, feces and urine were collected before surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cirrhosis Portal
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Jan 2025
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing TIPS due to complications related to portal hypertension；
Who may be able to join
- Patients undergoing TIPS due to complications related to portal hypertension；
- Age between 18 to 85 years;
- Signed informed consent;
Who cannot join
- Combined with liver cancer (out of the Milan criteria) or combined with other organ malignancies which had less than 3 months of expected survival;
- Combined with severe cardiopulmonary disease (severe pulmonary hypertension and heart failure or severe heart valve insufficiency or renal insufficiency), the expected survival is less than 3 months;
- Failure of TIPS procedure;
- Women who plan to become pregnant or who are pregnant or breastfeeding；
- Conditions deemed unsuitable for study participation by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang hospital, Southern Medical Uiversity
Guangzhou, Guangdong, 510080
Xiaofeng Zhang, +8618565552050, 1282614092@qq.com
About this study
Official title: Transjugular Intrahepatic Portosystemic Shunt for Patients With Portal Hypertension: an Observational, Cohort Study
This is a single-center, prospective, observational study intended to include patients receiving TIPS for portal hypertension. Baseline data of enrolled patients were recorded, and samples of ascites, feces and urine were collected before surgery. Venous blood (superior mesenteric vein, hepatic vein, peripheral vein) from different parts of the entero-hepatic axis was retained during operation, and patients were followed up regularly for 2 years. The incidence of infection, hepatic encephalopathy, upper gastrointestinal hemorrhage and ascites in patients with portal hypertension who received TIPS intervention were observed within 3 months after operation. And the stent patency was observed within 2 years after surgery. To investigate the characteristics of microbial, protein and metabolic components on enterohepatic axis and their relationship with prognosis of patients with cirrhosis by detecting microbiome, proteome and metabolome.
- Conditions
- Cirrhosis Portal
- Being tested
- No intervention, observational study
- Keywords
- Transjugular intrahepatic porsystemic shunt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observational studyOther
Observational study, no intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing TIPS procedure | Patients undergoing TIPS procedure due to portal hypertension-related complications Receives: Other: No intervention, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIPS shunt dysfunction
Measured: two years
Secondary outcomes (2)
death
Measured: 2 years
liver transplant
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Jan 2021
- Primary completion1 Jul 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis PortalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221982
- Sponsor's protocol ID
- NFEC-2021-005
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 24 Jan 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 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transjugular Intrahepatic Portosystemic Shunt for Patients With Portal Hypertension: an Observational, Cohort Study
- ClinicalTrials.gov ID
- NCT06221982
- Acronym / sponsor ID
- NFEC-2021-005
- Conditions
- Cirrhosis Portal
- Keywords
- Transjugular intrahepatic porsystemic shunt
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 24 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.
This is a single-center, prospective, observational study intended to include patients receiving TIPS for portal hypertension. Baseline data of enrolled patients were recorded, and samples of ascites, feces and urine were collected before surgery. Venous blood (superior mesenteric vein, hepatic vein, peripheral vein) from different parts of the entero-hepatic axis was retained during operation, and patients were followed up regularly for 2 years. The incidence of infection, hepatic encephalopathy, upper gastrointestinal hemorrhage and ascites in patients with portal hypertension who received TIPS intervention were observed within 3 months after operation. And the stent patency was observed within 2 years after surgery. To investigate the characteristics of microbial, protein and metabolic components on enterohepatic axis and their relationship with prognosis of patients with cirrhosis by detecting microbiome, proteome and metabolome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing TIPS procedure | – | Other: No intervention, observational studyPatients undergoing TIPS procedure due to portal hypertension-related complications |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing TIPS due to complications related to portal hypertension；
Key inclusion criteria (3 listed)
- Patients undergoing TIPS due to complications related to portal hypertension；
- Age between 18 to 85 years;
- Signed informed consent;
Key exclusion criteria (5 listed)
- Combined with liver cancer (out of the Milan criteria) or combined with other organ malignancies which had less than 3 months of expected survival;
- Combined with severe cardiopulmonary disease (severe pulmonary hypertension and heart failure or severe heart valve insufficiency or renal insufficiency), the expected survival is less than 3 months;
- Failure of TIPS procedure;
- Women who plan to become pregnant or who are pregnant or breastfeeding；
- Conditions deemed unsuitable for study participation by the investigator.
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 |
|---|---|---|
| No intervention, observational studyObservational study, no intervention | Other | Patients undergoing TIPS procedure |
Primary outcome
TIPS shunt dysfunction
Time frame: two years
2 secondary outcomes
death
Time frame: 2 years
liver transplant
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Cirrhosis Portal
RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy
Not yet recruiting
Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients
Hepatic Encephalopathy, Liver Cirrhosis
Not yet recruitingObservational study
Within-Session Repeatability of EUS-Guided Portal Pressure Gradient Measurement
Portal Hypertension, Chronic Liver Disease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Not yet recruiting
"Anticipant"-TIPS After a First Portal-hypertension-related Complication in Cirrhosis
Cirrhosis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis Portal, run by Nanfang Hospital, Southern Medical University at 1 site 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 3 inclusion and 5 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 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Xiaofeng Zhang (+8618565552050, 1282614092@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TIPS shunt dysfunction (time frame: two years). 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 24 Jan 2024.