TIPS for PH Patients: an Observational, Cohort Study

N

Nanfang Hospital, Southern Medical University

Status

Enrolling

Conditions

Cirrhosis Portal

Treatments

Other: No intervention, observational study

Study type

Observational

Funder types

Other

Identifiers

NCT06221982
NFEC-2021-005

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

Patients undergoing TIPS procedure
Description:
Patients undergoing TIPS procedure due to portal hypertension-related complications
Treatment:
Other: No intervention, observational study

Trial contacts and locations

1

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Central trial contact

Xiaofeng Zhang

Data sourced from clinicaltrials.gov

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