Prospective Cohort Study of Pheochromocytoma/Paraganglioma (NCT07516275) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prospective Cohort Study of Pheochromocytoma/Paraganglioma
200 participantsStarted 2026-04
Plain-language summary
The study will enroll patients scheduled for PPGL removal surgery at Peking Union Medical College Hospital. Before surgery, researchers will use a 6-variable model to predict the patient's risk of experiencing severe blood pressure swings during the operation. During surgery, a real-time early warning tool will be tested for its ability to accurately predict blood pressure changes 60 seconds in advance. The study will also explore the value of continuous glucose monitoring (CGM) in understanding blood pressure fluctuations and evaluate the performance of an artificial intelligence (AI) agent for preoperative anesthesia assessment, comparing its accuracy, consistency, and efficiency against that of human anesthesiologists.
Participation involves no changes to the patient's standard surgical or medical care. It includes collecting clinical data, wearing a CGM sensor from the day before to the day after surgery, and having the preoperative assessment performed by both the AI agent and anesthesiologists.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years.
* Diagnosed with pheochromocytoma/paraganglioma by imaging and laboratory tests and scheduled for elective resection.
* Planned intraoperative continuous invasive arterial pressure monitoring.
* Willing and able to provide written informed consent.
* Able to comply with preoperative CGM monitoring, AI agent assessment, and postoperative follow-up.
Exclusion Criteria:
* Intraoperative hemodynamic data missing ≥20%.
* Postoperative histopathology excludes PPGL diagnosis.
* Cardiac paraganglioma or metastatic PPGL.
* Severe cardiac disease (e.g., severe valvular disease, severe heart failure) that could independently cause intraoperative HDI.
* Pregnancy or breastfeeding.
* Mental illness, cognitive impairment, or communication barriers that prevent compliance with study procedures.
* Refusal to undergo CGM monitoring or AI agent assessment.
* Major illness (e.g., acute myocardial infarction, stroke, severe infection) within 3 months prior to surgery.
* Severe hepatic or renal insufficiency (Child-Pugh class C, eGFR \<30 ml/min/1.73 m²).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Predictive Model Discrimination (AUROC)
Timeframe: From preoperative assessment up to end of surgery