Observational study on patients with portal hypertension receiving TIPS
Transjugular Intrahepatic Portosystemic Shunt for Patients With Portal Hypertension: an Observational, Cohort Study
This study looks at patients with portal hypertension who are getting a specific procedure called TIPS to see how it affects their health and what complications might arise over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06221982 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients undergoing Transjugular Intrahepatic Portosystemic Shunt (TIPS) for portal hypertension. It involves collecting baseline data and biological samples from patients before surgery, followed by regular follow-ups for two years to monitor complications such as infections and hepatic encephalopathy. The study aims to analyze the microbial, protein, and metabolic components of the enterohepatic axis and their relationship with patient prognosis. The findings could provide insights into the outcomes of TIPS interventions in patients with cirrhosis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 undergoing TIPS due to complications from portal hypertension.
Not a fit: Patients with liver cancer, severe cardiopulmonary disease, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the factors influencing outcomes in patients with portal hypertension, potentially leading to improved management strategies.
How similar studies have performed: While the approach of analyzing microbial and metabolic components in relation to TIPS outcomes is innovative, similar observational studies have shown promise in understanding patient prognoses in related conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients undergoing TIPS due to complications related to portal hypertension； 2. Age between 18 to 85 years; 3. Signed informed consent; Exclusion Criteria: 1. Combined with liver cancer (out of the Milan criteria) or combined with other organ malignancies which had less than 3 months of expected survival; 2. 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; 3. Failure of TIPS procedure; 4. Women who plan to become pregnant or who are pregnant or breastfeeding； 5. Conditions deemed unsuitable for study participation by the investigator.
Where this trial is running
Guangzhou, Guangdong
- Nanfang hospital, Southern Medical Uiversity — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Xiaofeng Zhang
- Email: 1282614092@qq.com
- Phone: +8618565552050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.