NCT07335042Recruiting
Prediction Model for MINS After Major Hepatobiliary Surgery
Development of an Interpretable Prediction Model for Myocardial Injury After Noncardiac Surgery in Patients Undergoing Major Hepatobiliary Surgery
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1800 (estimated)
- First submitted
- 4 Jan 2026
- Start date
- 14 Jan 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07335042
What you commit to
- Study type: Observational
- Planned participants: 1800
- From 14 Jan 2026 to the primary completion date, 31 Dec 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- (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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University International Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine，Tsinghua University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Affiliated Hospital of Army Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| Qingdao West Coast New Area People's Hospital Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| The First Affiliated Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Shandong | China | Recruiting |
| Zhuhai People's Hospital Coordinator of this site? Confirm its status | Zhuhai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.