PGLMI-PPGLNCT05752773
Prediction of Myocardial Injury After Laparoscopic Pheochromocytoma/ParaGangLioma Resection
An observational study of PGL, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- PGL
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2023to 31 May 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From January 2013 to May 2025, adult patients underwent elective laparoscopic PPGL resection.
Who may be able to join
- Scheduled for Laparoscopic PPGL resection
Who cannot join
- Open or laparoscopic conversion to open PPGL resection was excluded
- Cardiac paraganglioma was excluded
- History of congenital heart disease or cardiac surgery was excluded
- Patients with preoperative troponin/hypersensitive troponin elevation were excluded
- Carotid body tumor and accessory ganglioma of jugular tympanum without endocrine function were excluded
Trial locations and contacts
1 site in 1 country.
YI-FEI ZHAO, MD contact
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital,Chinese Academy of Medical Science and Peking Union Medical College
Beijing, Beijing Municipality, 100730
LING LAN, MD, lanling_1988@163.com
About this study
Official title: 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:
- What are the risk factors for myocardial injury after laparoscopic PPGL resection？
- 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.
Read the 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.
- Conditions
- PGL
- Keywords
- myocardial injury, prediciton, pheochromocytoma/paraganglioma
- Medical subject headings
- Pheochromocytoma, Paraganglioma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30days after surgery
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 30days after surgery
New atrial fibrillation
new atrial fibrillation heart rate confirmed by electrocardiogram or color Doppler ultrasound after surgery.
Measured: 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
Measured: 30days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start6 Feb 2023
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PGLStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 700 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lan Ling, Peking Union Medical College Hospital
- Investigators
- LING LAN, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752773
- Sponsor's protocol ID
- 2022-PUMCH-B-0071
- Acronym
- MI-PPGL
- Status last verified
- Mar 2023
- First submitted
- 21 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lan L, Ma Y, Zhao Y, Li Y, Zhang Y, Shen L, Zhang Y, Huang Y. Prediction of postoperative myocardial injury in patients undergoing laparoscopic pheochromocytoma/paraganglioma resection: protocol for an ambispective cohort study. BMJ Open. 2025 Feb 7;15(2):e091975. doi: 10.1136/bmjopen-2024-091975.
PubMed 39920072
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Identification and Prediction of Myocardial Injury After Laparoscopic Pheochromocytoma/Paraganglioma Resection:A Ambispective Cohort Study.
- ClinicalTrials.gov ID
- NCT05752773
- Acronym / sponsor ID
- MI-PPGL / 2022-PUMCH-B-0071
- Conditions
- PGL
- Keywords
- myocardial injury, prediciton, pheochromocytoma/paraganglioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study was conducted in patients undergoing elective laparoscopic pheochromocytoma/paraganglioma(PPGL) resection. It mainly answers the following two main questions:
- What are the risk factors for myocardial injury after laparoscopic PPGL resection？
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2013 to May 2025, adult patients underwent elective laparoscopic PPGL resection.
Key inclusion criteria (1 listed)
- Scheduled for Laparoscopic PPGL resection
Key exclusion criteria (5 listed)
- Open or laparoscopic conversion to open PPGL resection was excluded
- Cardiac paraganglioma was excluded
- History of congenital heart disease or cardiac surgery was excluded
- Patients with preoperative troponin/hypersensitive troponin elevation were excluded
- Carotid body tumor and accessory ganglioma of jugular tympanum without endocrine function were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Myocardial injury after laparoscopic PPGL resection
Time frame: 30days after surgery
Myocardial injury was defined as an elevated troponin I level exceeding the 99th percentile upper reference limit due to cardiac ischemic causes.
5 secondary outcomes
Acute myocardial infarction
Time frame: 30days after surgery
Nonfatal cardiac arrest
Time frame: 30days after surgery
Congestive heart failure
Time frame: 30days after surgery
New atrial fibrillation
Time frame: 30days after surgery
Stroke
Time frame: 30days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Derived from this study: PubMed 39920072Lan L, Ma Y, Zhao Y, Li Y, Zhang Y, Shen L, Zhang Y, Huang Y. Prediction of postoperative myocardial injury in patients undergoing laparoscopic pheochromocytoma/paraganglioma resection: protocol for an ambispective cohort study. BMJ Open. 2025 Feb 7;15(2):e091975. doi: 10.1136/bmjopen-2024-091975.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YI-FEI ZHAO, MD contact
LING LAN, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PGL, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LING LAN, MD (+86-18515311407, lanling_1988@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial injury after laparoscopic PPGL resection (time frame: 30days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05752773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.