Clinical trial NCT05752773: Prediction of Myocardial Injury After Laparoscopic Pheochromocytoma/ParaGangLioma Resection
Official title: Risk Identification and Prediction of Myocardial Injury After Laparoscopic Pheochromocytoma/Paraganglioma Resection:A Ambispective Cohort Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PGL
Keywords: myocardial injury
prediciton
pheochromocytoma/paraganglioma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: From January 2013 to May 2025, adult patients underwent elective laparoscopic PPGL resection.

Brief summary: 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.

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 myocardial injury.

The investigators 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). The investigators 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 the investigators 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.

Eligibility criteria: 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

Primary outcomes:
measure: Myocardial injury after laparoscopic PPGL resection
timeFrame: 30days after surgery
Secondary outcomes:
measure: Acute myocardial infarction
timeFrame: 30days after surgery
measure: Nonfatal cardiac arrest
timeFrame: 30days after surgery
measure: Congestive heart failure
timeFrame: 30days after surgery
measure: New atrial fibrillation
timeFrame: 30days after surgery
measure: Stroke
timeFrame: 30days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital,Chinese Academy of Medical Science and Peking Union Medical College
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: LING LAN, MD
role: PRINCIPAL_INVESTIGATOR
References: