Prediction Model for MINS After Major Hepatobiliary Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorBeijing Tsinghua Chang Gung Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

1800

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Major Hepatobiliary Surgery

    Procedure/Surgery

    Patients undergo standard major hepatobiliary surgery (e.g., hepatectomy). The specific surgical strategy, including the method of hepatic inflow occlusion (e.g., Pringle maneuver or SPVO), is determined by the attending surgeon based on routine clinical practice and patient condition, not by the study protocol.

Treatment groups

1,800 Participants
are divided into 2 treatment groups
Group A: Training set1 intervention
Group B: External validation set1 intervention

Trial outcomes

Primary outcomes

1

The area under the receiver operating characteristic curve (AUC) of predictive model

The area under the receiver operating characteristic curve (AUC) for predicting myocardial injury after noncardiac surgery (MINS) in patients undergoing major hepatobiliary surgery

Time frame
Within 3 days after surgery

Secondary outcomes

1

Model calibration

assessed by calibration curve / Hosmer-Lemeshow test

Time frame
Within 3 days after surgery
2

Decision curve analysis (DCA)-derived clinical net benefit

Time frame
Within 3 days after surgery
3

Model stability and generalizability in the external validation cohort

Time frame
Within 3 days after surgeries
4

Contribution weight of key variables (SPVO, biomarkers) analyzed via SHAP

Time frame
Within 3 days after surgeires

Other outcomes

Sponsors and contacts

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