TIPS for PH Patients: an Observational, Cohort Study

NCT06221982 | Unknown

• 1 other identifier: NFEC-2021-005
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis Portal

Keywords

Transjugular intrahepatic porsystemic shunt

Outcome Measures

Primary Outcomes (1)

• TIPS shunt dysfunction

  two years

Secondary Outcomes (2)

• death

  2 years

• liver transplant

  2 years

Study Arms (1)

Patients undergoing TIPS procedure

Patients undergoing TIPS procedure due to portal hypertension-related complications

Other: No intervention, observational study

Interventions

No intervention, observational study OTHER

Observational study, no intervention

Patients undergoing TIPS procedure

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing TIPS due to complications related to portal hypertension；

You may qualify if:

• Patients undergoing TIPS due to complications related to portal hypertension；
• Age between 18 to 85 years;
• Signed informed consent;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang hospital, Southern Medical Uiversity

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Xiaofeng Zhang

CONTACT

+8618565552050; 1282614092@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 24, 2024
• Study Start: January 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: January 31, 2025
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)