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RECRUITING
NCT07335042

Prediction Model for MINS After Major Hepatobiliary Surgery

Sponsor: Beijing Tsinghua Chang Gung Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Development of an Interpretable Prediction Model for Myocardial Injury After Noncardiac Surgery in Patients Undergoing Major Hepatobiliary Surgery

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

1800

Start Date

2025-06-11

Completion Date

2027-06-30

Last Updated

2026-01-12

Healthy Volunteers

No

Interventions

PROCEDURE

Major Hepatobiliary 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.

Locations (6)

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

Beijing, China

Peking University International Hospital

Beijing, China

The First Affiliated Hospital of Army Medical University

Chongqing, China

Qingdao West Coast New Area People's Hospital

Qingdao, China

The First Affiliated Hospital of Shandong First Medical University

Shandong, China

Zhuhai People's Hospital

Zhuhai, China