Prediction Model for MINS After Major Hepatobiliary Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-11

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hepatic and Systemic Hemodynamic Modeling During Liver Surgery

NCT05339984

Liver Diseases Liver Transplantation

RECRUITING NA

Impact of Minimally Invasive and Open Liver Surgery in Different BMI-classes

NCT05475054

Liver Cancer Liver Metastases Obesity

COMPLETED

ICG- Livertest Versus New Biomarkers as Prognostic Markers in Critically Ill ICG- Livertest Versus New Biomarkers as Prognostic Markers in Critically Ill

NCT01317381

Critically Ill Patients

UNKNOWN

Impact of Age and BMI on Liver Transplant Outcomes

NCT04853641

Liver Transplant; Complications Perioperative/Postoperative Complications

COMPLETED

Controlled Low Central Venous Pressure Combined With Hilar Block in Laparoscopic Hepatectomy

NCT03422913

Laparoscopic Hepatectomy

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study Design and Methodology: The study consists of four consecutive phases aimed at constructing a robust and interpretable prediction model for MINS.

1. Multi-center Cohort Standardization: Based on clinical data from multiple participating centers, the investigators will establish a standardized structural dataset. Strict inclusion and exclusion criteria will be applied. The process involves rigorous data cleaning and normalization to harmonize demographics, surgical operation details, and perioperative hemodynamic parameters across different centers, laying the foundation for model construction.
2. Nested Modeling and Performance Evaluation: A nested modeling strategy will be employed to assess the incremental predictive value of specific surgical and biological variables:

Model A (Baseline): Constructed using standard baseline variables such as the Revised Cardiac Risk Index (RCRI).

Model B (+Surgical Technique): Incorporates hepatic inflow occlusion strategies, specifically comparing SPVO (Selective Pringle Vascular Occlusion) vs. Pringle maneuver, along with occlusion duration and frequency.

Model C (Full Model): Further incorporates MINS-related biomarkers.

Model performance will be comprehensively evaluated using:

Discrimination: Area Under the Receiver Operating Characteristic Curve (AUC).

Calibration: Calibration plots.

Clinical Utility: Net Reclassification Improvement (NRI) and Decision Curve Analysis (DCA) to assess the improvement in risk stratification and clinical net benefit after adding new variables.
3. Model Interpretability Analysis: To enhance the transparency of the model ("White-box" approach), SHAP (SHapley Additive exPlanations) values or similar methods will be utilized. This will quantify and visualize the specific contribution (weight) of key variables, such as SPVO usage, to the individual risk prediction, aligning the statistical results with clinical medical reasoning.
4. External Validation: The final model will undergo validation using an independent external clinical cohort. This step aims to test the stability and generalizability of the model across different center data, defining its applicable scope in real-world clinical scenarios.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myocardial Injury After Noncardiac Surgery (MINS) Postoperative Complications Liver Neoplasm Hepatobiliary Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study Cohort

Adult patients scheduled for major hepatobiliary surgery at Beijing Tsinghua Chang Gung Hospital and other participating centers.

Major Hepatobiliary Surgery

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhifeng Gao

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhifeng Gao, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tsinghua Changgeng Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Beijing, , China

Site Status RECRUITING