TIPS for PH Patients: an Observational, Cohort Study

January 15, 2024 updated by: Nanfang Hospital, Southern Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Nanfang hospital, Southern Medical Uiversity
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing TIPS due to complications related to portal hypertension；

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing TIPS procedure
Patients undergoing TIPS procedure due to portal hypertension-related complications
Other: No intervention, observational study
Observational study, no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TIPS shunt dysfunction
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
death
Time Frame: 2 years
2 years
liver transplant
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

January 15, 2024

First Posted (Estimated)

January 24, 2024

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2021-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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