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Trial Title:
Prediction of Myocardial Injury After Laparoscopic Pheochromocytoma/ParaGangLioma Resection
NCT ID:
NCT05752773
Condition:
PGL
Conditions: Official terms:
Pheochromocytoma
Paraganglioma
Conditions: Keywords:
myocardial injury
prediciton
pheochromocytoma/paraganglioma
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
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.
Criteria for eligibility:
Study pop:
From January 2013 to May 2025, adult patients underwent elective laparoscopic PPGL
resection.
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital,Chinese Academy of Medical Science and Peking Union Medical College
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
LING LAN, MD
Email:
lanling_1988@163.com
Start date:
February 6, 2023
Completion date:
May 31, 2025
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05752773
