Clinical Efficacy and Survival Prediction Analysis of Transjugular Intrahepatic Portosystemic Shunt in Patients With Liver Cirrhosis

NCT07437638 | Active Not Recruiting

• 1 other identifier: 2024IIT049
• Study Type: observational
• Target: 624
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop a practical tool for identifying cirrhotic patients at high risk of hepatic encephalopathy following transjugular intrahepatic portosystemic shunt (TIPS) placement. A retrospective analysis will be conducted on medical records of 624 cirrhotic patients who underwent TIPS from 2011 to 2021. Statistical methods will be applied to screen preoperative routine indicators associated with post-TIPS hepatic encephalopathy risk. A predictive nomogram will be constructed incorporating the screened indicators to estimate individual preoperative risk. The predictive performance will be compared with conventional clinical scoring systems. This tool is intended to facilitate preoperative risk evaluation and targeted management of high-risk patients undergoing TIPS

Conditions

Liver Cirrhosis; Hepatic Encephalopathy; TIPS

Keywords

cirrhosis; transjugular intrahepatic portosystemic shunt; hepatic encephalopathy; prognosis; nomogram

Outcome Measures

Primary Outcomes (1)

• Occurrence of hepatic encephalopathy within 3 months after TIPS

  The development of hepatic encephalopathy, diagnosed based on clinical assessment and medical records during follow-up outpatient visits or hospital readmissions within 3 months after the TIPS procedure. All HE cases in this study occurred within this period.

  3-month follow-up after TIPS

Study Arms (2)

HE Group

Cirrhotic patients who underwent TIPS and were subsequently diagnosed with hepatic encephalopathy within 3 months after the procedure, as identified through a retrospective review of electronic medical records.

Non-HE Group

Cirrhotic patients who underwent TIPS and remained free from a diagnosis of hepatic encephalopathy throughout the 3-month follow-up period after the procedure, as confirmed by retrospective review of medical records

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This retrospective study included 624 patients with liver cirrhosis who underwent TIPS at the Second Affiliated Hospital of Chongqing Medical University between May 2011 and December 2021

You may qualify if:

• Age 18-80 years, regardless of gender
• Diagnosis of decompensated cirrhosis meeting clinical guidelines
• Complete preoperative baseline data available, with regular postoperative follow-up for at least 3 months to assess endpoint events
• Absence of absolute contraindications for TIPS

You may not qualify if:

• Age \< 18 or \> 80 years
• Non-cirrhotic portal hypertension
• Hepatocellular carcinoma or other systemic malignancies
• Severe cardiopulmonary disease
• Prior liver transplantation or portosystemic shunt surgery
• Death or liver transplantation within 30 days post-TIPS
• Missing key baseline data or loss to follow-up

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

Chongqing

Chongqing, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

This is a retrospective, observational study. No biospecimens (e.g., blood, tissue) were collected or retained specifically for this research. All analyses were performed using previously obtained and anonymized clinical laboratory data extracted from electronic medical records

MeSH Terms

Conditions

Liver Cirrhosis; Hepatic Encephalopathy; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 27, 2026
• Study Start: September 1, 2024
• Primary Completion: April 5, 2026
• Study Completion: April 5, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)