TIPS for PH Patients: an Observational, Cohort Study

Cirrhosis Portal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06221982
• Other study ID #: NFEC-2021-005
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: January 31, 2025

Study information

• Verified date: January 2024
• Source: Nanfang Hospital, Southern Medical University
• Contact: Xiaofeng Zhang
• Phone: +8618565552050
• Email: 1282614092[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 31, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cirrhosis Portal
• Fibrosis

Intervention

Other:
• No intervention, observational study
Observational study, no intervention

Locations

Country	Name	City	State
China	Nanfang hospital, Southern Medical Uiversity	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TIPS shunt dysfunction		two years
Secondary	death		2 years
Secondary	liver transplant		2 years