TIPS for PH Patients: an Observational, Cohort Study

Recruiting

• Conditions: Cirrhosis Portal
• Interventions: Other: No intervention, observational study

• Registration Number: NCT06221982
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-15
• Study First Submitted QC: 2024-01-15
• Last Update Submitted: 2024-01-15
• Study First Posted: 2024-01-24
• Last Update Posted: 2024-01-24
• Primary Completion: 2024-07-01
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing TIPS procedure	No intervention, observational study	Patients undergoing TIPS procedure due to portal hypertension-related complications

Primary Outcome Measures

Name	Time	Method
TIPS shunt dysfunction	two years

Secondary Outcome Measures

Name	Time	Method
death	2 years
liver transplant	2 years

Trial Locations

Locations (1)

Nanfang hospital, Southern Medical Uiversity; 🇨🇳 Guangzhou, Guangdong, China