Prediction of Myocardial Injury After Laparoscopic Pheochromocytoma/ParaGangLioma Resection (MI-PPGL)

Risk Identification and Prediction of Myocardial Injury After Laparoscopic Pheochromocytoma/Paraganglioma Resection:A Ambispective Cohort Study.

This observational study was conducted in patients undergoing elective laparoscopic pheochromocytoma/paraganglioma(PPGL) resection. It mainly answers the following two main questions:

1. What are the risk factors for myocardial injury after laparoscopic PPGL resection？
2. How to establish the myocardial injury prediction model of laparoscopic PPGL resection?

Participants were not required to perform additional research work other than the usual postoperative follow-up within 30 days after surgery. No control group was set in this study, and no additional clinical intervention was performed.

Study Overview

• Status: Recruiting
• Conditions: PGL

Detailed Description

MI-PPGL is a single-center observational ambispective cohort study.On the basis of retrospective study, the research team plans to build a structured database to investigate the incidence of myocardial injury in laparoscopic PPGL-resection, and further analyze myocardial injury related risk factors. In particular, timing data such as vital signs(blood pressure,heart rate)will be included to construct an efficient and robust myocardial injury prediction model. At the same time, a prospective cohort study is carried out to verify the model, so as to test the prediction ability of myocardial injury and reduce the incidence of MINS.

We expect to enroll 700 patients, including at least 550 patients retrospectively and 150 patients prospectively.In this study, the main endpoint events of the prediction model are binary outcome. Conservatively estimated according to the "10EPV" principle, that is, each predictive factor included in the model needs at least 10 positive outcome endpoint for estimation (10 events per variable). We expected 5 to 8 predictors to be included in the model, and at least 80 positive events to be included. The incidence of perioperative myocardial injury is 12~20%, so the estimated sample size was at least 666 patients. Considering the absence of data or subject withdrawal from the study. so we expected to include 700 patients, including at least 550 retrospectively and 150 prospectively.

STATA (version 15.0; Stata Corp., TX, USA) and R 3.6.1 software (R Foundation for Statistical Computing, Vienna, Austria) will be used for statistical analysis. Binary logistic regression was used to screen risk factors and stratify risk levels. P<0.05 was considered statistically significant. For predictive modeling, clinical databases were 9:1 or 8: 2. Randomly split into training samples and verification samples. In the training samples, optimal subset method and LASSO regression will be used for feature selection.Receiver operating characteristic curve (ROC curve) was used to represent the model differentiation, and Nomogram was used to represent the predictive factors of multiple logistic regression. In the verification samples, Hosmer-Lemeshow goodness of fit test was used to test the calibration degree of the model, and P>0.05 was the acceptable level of estimated fitting of the model. Decision curve analysis (DCA curve) was used to verify the clinical applicability.

• Study Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

• Study Contact: Name: LING LAN, MD; Phone Number: +86-18515311407; Email: lanling_1988@163.com
• Study Contact Backup: Name: YI-FEI ZHAO, MD

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital,Chinese Academy of Medical Science and Peking Union Medical College
      • Contact: LING LAN, MD; Email: lanling_1988@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

From January 2013 to May 2025, adult patients underwent elective laparoscopic PPGL resection.

Description

Inclusion Criteria:

• Scheduled for Laparoscopic PPGL resection

Exclusion Criteria:

1. Open or laparoscopic conversion to open PPGL resection was excluded
2. Cardiac paraganglioma was excluded
3. History of congenital heart disease or cardiac surgery was excluded
4. Patients with preoperative troponin/hypersensitive troponin elevation were excluded
5. Carotid body tumor and accessory ganglioma of jugular tympanum without endocrine function were excluded

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial injury after laparoscopic PPGL resection	Myocardial injury was defined as an elevated troponin I level exceeding the 99th percentile upper reference limit due to cardiac ischemic causes.	30days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute myocardial infarction	An increase in troponin exceeding 99% of the reference limit is associated with at least one of the following: 1. Symptoms of myocardial ischemia; 2. New ECG ischemic changes (ST elevation or depression or abnormal Q wave; 3. Imaging findings of abnormal new ventricular wall movement or loss of viable myocardia consistent with ischemic etiology; 4. Coronary thrombosis was confirmed by coronary intervention (angiography) or autopsy.	30days after surgery
Nonfatal cardiac arrest	An event in which cardiac activity abruptly stops, usually through CPR and/or defibrillation or cardioversion, or cardiac pacing reversal, resulting in a loss of normal signs of breathing and spontaneous circulation.	30days after surgery
Congestive heart failure	Patients with new postoperative symptoms and signs: fatigue, dyspnea, upright breathing, paroxysmal dyspnea at night, increased jugular vein pressure, wet rales found on physical examination, heart enlargement, pulmonary vascular congestion.	30days after surgery
New atrial fibrillation	new atrial fibrillation heart rate confirmed by electrocardiogram or color Doppler ultrasound after surgery.	30days after surgery
Stroke	CT or MRI showing cerebral infarction or cerebral hemorrhage or new neurological symptoms (hemiplegia, decreased muscle strength, or dysphonia) lasting more than 24 hours	30days after surgery

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: LING LAN, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Anticipated): May 31, 2025
• Study Completion (Anticipated): May 31, 2025

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Estimate): March 3, 2023

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: myocardial injury; prediciton; pheochromocytoma/paraganglioma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Pheochromocytoma; Paraganglioma
• Other Study ID Numbers: 2022-PUMCH-B-0071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No