🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07335042
Recruiting Observational

Prediction Model for MINS After Major Hepatobiliary Surgery

NCT07335042 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Tsinghua Chang Gung Hospital
Phase
Observational
Started
2026-01-14
Last updated
2026-06-15

Condition(s) studied

Myocardial Injury After Noncardiac Surgery (MINS)Postoperative ComplicationsLiver NeoplasmHepatobiliary Diseases

Investigational drug(s) / intervention(s)

Major Hepatobiliary Surgery

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: Adults (18-85 yr, ASA physical status II-III) undergoing major hepatobiliary surgery were enrolled. Major surgery was defined as duration ≥ 3 h involving hepatectomy (≥ 3 segments) or biliary reconstruction necessitating ICU admission. Eligibility required paired perioperative high-sensitivity cardiac troponin T (hs-cTnT) data and comprehensive documentation of surgical covariates, including surgical approach (laparoscopic vs. open), resection nature (anatomic vs. non-anatomic), number of resected segments, tumor characteristics (size and location), and presence of cirrhosis. Exclusion Criteria: (1) preoperative acute myocardial infarction, unstable angina, heart failure, or chronic kidney disease (estimated glomerular filtration rate \< 60 ml/ (min · 1.73 m2); (2) undocumented inflow occlusion strategy; or (3) non-imputable missing covariates.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine,Tsinghua University Beijing China Recruiting
Peking University International Hospital Beijing China Recruiting
The First Affiliated Hospital of Army Medical University Chongqing China Recruiting
Qingdao West Coast New Area People's Hospital Qingdao China Recruiting
The First Affiliated Hospital of Shandong First Medical University Shandong China Recruiting
Zhuhai People's Hospital Zhuhai China Recruiting

More Beijing Tsinghua Chang Gung Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07335042 on ClinicalTrials.gov ↗ ← All trials in China