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Active, not recruitingNCT07437638Updated Feb 27, 2026

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

An observational study in Liver Cirrhosis, Hepatic Encephalopathy and TIPS, sponsored by The Second Affiliated Hospital of Chongqing Medical University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by The Second Affiliated Hospital of Chongqing Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
624
Ages
18 Years to 80 Years
Sex
All
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Study 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

Read the detailed description

Background: Transjugular intrahepatic portosystemic shunt (TIPS) is an important treatment for the complications of portal hypertension. However, hepatic encephalopathy remains a major complication after TIPS, and its independent risk factors are not fully elucidated. The purpose of this study is to investigate the independent risk factors of hepatic encephalopathy (HE) after TIPS in patients with liver cirrhosis, and to construct a nomogram model to identify high-risk patients before TIPS.

Method: This retrospective study will include cirrhotic patients who underwent TIPS at the Second Affiliated Hospital of Chongqing Medical University between 2011 and 2021. Patients will be randomly split into training (70%) and validation (30%) cohorts. Predictors will be selected using LASSO regression with cross-validation and further analyzed via multivariable logistic regression to build a nomogram. Model performance will be evaluated and compared with conventional scores (MELD, MELD-Na, ALBI, FIPS).

Result: To be reported after study completion. Conclusion: A nomogram based on routine preoperative variables is hypothesized to predict HE risk after TIPS. This study intends to provide a tool for preoperative risk stratification and individualized patient management.

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

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Conditions studied

  • Liver Cirrhosis
  • Hepatic Encephalopathy
  • TIPS

Keywords

  • cirrhosis
  • transjugular intrahepatic portosystemic shunt
  • hepatic encephalopathy
  • prognosis
  • nomogram
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's enrollment of 624 is above the median of 151 across 587 observational studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University is the lead sponsor of 98 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
624 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

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What researchers measure

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.

    Time frame: 3-month follow-up after TIPS

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Study locations

1 site
  • Chongqing
    Chongqing, China
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References and documents

Individual participant data

Plan to share: No — The individual participant data collected for this observational study contain sensitive personal health information (e.g., detailed clinical outcomes and laboratory results). To protect participant privacy and confidentiality in accordance with local data protection regulations and the approved ethics protocol, the datasets will not be publicly deposited. Data are owned by the chongqing Medical University and may be available upon reasonable request to the corresponding author for purposes of verification or collaborative research, subject to a formal data sharing agreement and institutional approvals.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07437638
Lead sponsor
The Second Affiliated Hospital of Chongqing Medical University
Responsible party
Juan Kang (Chief Physician, The Second Affiliated Hospital of Chongqing Medical University) — Principal investigator
First posted
Feb 27, 2026
Start date
Sep 1, 2024
Primary completion
Apr 5, 2026 (estimated)
Completion
Apr 5, 2026 (estimated)
Last update
Feb 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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