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TIPS for PH Patients: an Observational, Cohort Study

Transjugular Intrahepatic Portosystemic Shunt for Patients With Portal Hypertension: an Observational, Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06221982
Enrollment
300
Registered
2024-01-24
Start date
2021-01-01
Completion date
2025-01-31
Last updated
2024-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis Portal

Keywords

Transjugular intrahepatic porsystemic shunt

Brief 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. 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.

Interventions

Observational study, no intervention

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
TIPS shunt dysfunctiontwo years

Secondary

MeasureTime frame
death2 years
liver transplant2 years

Countries

China

Contacts

Primary ContactXiaofeng Zhang
1282614092@qq.com+8618565552050

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026