Prospective Cohort Study of Pheochromocytoma/Paraganglioma
Starting soon
Conditions studied: Pheochromocytoma, Paraganglioma, Hemodynamic Instability, Intraoperative Complications
In brief
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.
Key facts
- Study ID
- NCT07516275
- Run by
- Peking Union Medical College Hospital
- People needed
- 200
- Starts
- 2026-04-01
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-04-07
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Full record on ClinicalTrials.gov
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