Actively Recruiting

Age: 18Years - 85Years
All Genders
NCT07335042

Prediction Model for MINS After Major Hepatobiliary Surgery

Led by Beijing Tsinghua Chang Gung Hospital · Updated on 2026-01-12

1800

Participants Needed

6

Research Sites

107 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This multi-center, prospective observational study aims to develop and validate an interpretable prediction model for Myocardial Injury After Noncardiac Surgery (MINS) in patients undergoing major hepatobiliary surgery. The study adopts a nested modeling strategy, starting with baseline risk factors (e.g., RCRI) and stepwise incorporating hepatic inflow occlusion strategies (specifically comparing SPVO vs. Pringle maneuver) and routine intraoperative biomarkers. The model's performance will be evaluated using AUC, Net Reclassification Improvement (NRI), and Decision Curve Analysis (DCA), followed by interpretability analysis using SHAP values and external validation in an independent cohort.

CONDITIONS

Official Title

Prediction Model for MINS After Major Hepatobiliary Surgery

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 85 years with ASA physical status II-III
  • Undergoing major hepatobiliary surgery lasting 3 hours or more, including hepatectomy of 3 or more segments or biliary reconstruction
  • Surgery requiring intensive care unit admission postoperatively
  • Availability of paired perioperative high-sensitivity cardiac troponin T (hs-cTnT) data
  • Complete documentation of surgical details such as surgical approach, resection type, number of segments removed, tumor size and location, and presence of cirrhosis
Not Eligible

You will not qualify if you...

  • History of acute myocardial infarction, unstable angina, heart failure, or chronic kidney disease with eGFR less than 60 ml/min/1.73 m² before surgery
  • Missing data on hepatic inflow occlusion strategy
  • Missing important surgical or clinical data that cannot be imputed

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine,Tsinghua University

Beijing, China

Actively Recruiting

2

Peking University International Hospital

Beijing, China

Not Yet Recruiting

3

The First Affiliated Hospital of Army Medical University

Chongqing, China

Not Yet Recruiting

4

Qingdao West Coast New Area People's Hospital

Qingdao, China

Not Yet Recruiting

5

The First Affiliated Hospital of Shandong First Medical University

Shandong, China

Not Yet Recruiting

6

Zhuhai People's Hospital

Zhuhai, China

Not Yet Recruiting

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Research Team

Z

Zhifeng Gao, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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