Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05752773
Status:
RECRUITING
Last Update Posted:
2023-03-08
First Post:
2023-02-21
Brief Title:
Prediction of Myocardial Injury After Laparoscopic PheochromocytomaParaGangLioma Resection
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Risk Identification and Prediction of Myocardial Injury After Laparoscopic PheochromocytomaParaganglioma ResectionA Ambispective Cohort Study
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MI-PPGL
Brief Summary:
This observational study was conducted in patients undergoing elective laparoscopic pheochromocytomaparagangliomaPPGL 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
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 studyOn 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 signsblood pressureheart ratewill 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 prospectivelyIn 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 1220 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 150 Stata Corp TX USA and R 361 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 P005 was considered statistically significant For predictive modeling clinical databases were 91 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 selectionReceiver 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 P005 was the acceptable level of estimated fitting of the model Decision curve analysis DCA curve was used to verify the clinical applicability
The investigators expect to enroll 700 patients including at least 550 patients retrospectively and 150 patients prospectivelyIn 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 1220 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 150 Stata Corp TX USA and R 361 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 P005 was considered statistically significant For predictive modeling clinical databases were 91 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 selectionReceiver 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 P005 was the acceptable level of estimated fitting of the model Decision curve analysis DCA curve was used to verify the clinical applicability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None