TIPS for PH Patients: an Observational, Cohort Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cirrhosis Portal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing TIPS procedure

Patients undergoing TIPS procedure due to portal hypertension-related complications

No intervention, observational study

Intervention Type OTHER

Observational study, no intervention

Interventions

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No intervention, observational study

Observational study, no intervention

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No