Prediction Model for MINS After Major Hepatobiliary Surgery

NCT07335042 | Recruiting

• 1 other identifier: 25454-4-01-01
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

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

Keywords

MINS; Major Hepatobiliary Surgery; Hepatectomy; Hepatic Inflow Occlusion; Pringle Maneuver; Prediction Model; High-sensitivity Cardiac Troponin

Outcome Measures

Primary Outcomes (1)

• Incidence of Myocardial Injury After Noncardiac Surgery

  MINS is defined as myocardial injury resulting from myocardial ischemia (that may or may not result in necrosis) occurring within 30 days after surgery. The diagnosis is based on a peak high-sensitivity cardiac troponin (hs-cTn) level exceeding the 99th percentile upper reference limit (URL) due to presumed ischemic etiology, irrespective of the presence of ischemic symptoms or electrocardiographic (ECG) changes. Routine hs-cTn screening will be performed on postoperative days 1, 2, and 3. Additional measurements will be taken if clinical signs of ischemia occur anytime within the 30-day follow-up period.

  Within 30 days after surgery

Secondary Outcomes (2)

• 30-day All-cause Mortality

  Within 30 days after surgery

• Postoperative Length of Hospital Stay

  Up to 90 days

Study Arms (1)

Study Cohort

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

Procedure: Major Hepatobiliary Surgery

Interventions

Major Hepatobiliary Surgery 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.

Study Cohort

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1800

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (6)

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

Beijing, China

RECRUITING

Peking University International Hospital

Beijing, China

NOT YET RECRUITING

The First Affiliated Hospital of Army Medical University

Chongqing, China

NOT YET RECRUITING

Qingdao West Coast New Area People's Hospital

Qingdao, China

NOT YET RECRUITING

The First Affiliated Hospital of Shandong First Medical University

Shandong, China

NOT YET RECRUITING

Zhuhai People's Hospital

Zhuhai, China

NOT YET RECRUITING

MeSH Terms

Conditions

Postoperative Complications; Liver Neoplasms; Digestive System Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Liver Diseases

Study Officials

• Zhifeng Gao, MD

  Beijing Tsinghua Changgeng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhifeng Gao, MD

CONTACT

+86-15801249466; gzfa02461@btch.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 12, 2026
• Study Start: June 11, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

CN (6)