Clinical trial · Observational
Prospective Cohort Study of Pheochromocytoma/Paraganglioma
Validation and Extension Study of the Predictive Model for Intraoperative Hemodynamic Instability in Pheochromocytoma/Paraganglioma Resection - a Single-center, Prospective, Observational Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hemodynamic Instability | — | UNRESOLVED | — |
| Intraoperative Complications | — | UNRESOLVED | — |
| Paraganglioma | Paraganglioma | ONTOLOGY_EXACT | 0.98 |
| Pheochromocytoma | Adrenal Gland Pheochromocytoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- PPGL Resection Cohort
- description
- Patients diagnosed with pheochromocytoma or paraganglioma who are scheduled for elective surgical resection. All participants will undergo the same study procedures: preoperative data collection, CGM monitoring, AI and human preoperative assessment, intraoperative application of the real-time warning tool, and postoperative follow-up. No intervention is applied; this is purely observational.
Primary outcomes (1)
- measure
- Predictive Model Discrimination (AUROC)
- timeFrame
- From preoperative assessment up to end of surgery
- description
- Discriminative ability of the preoperative 6-variable model for predicting severe intraoperative hemodynamic instability (HDI) subtype, assessed by the Area Under the Receiver Operating Characteristic Curve (AUROC).
Secondary outcomes (6)
- measure
- Real-time Warning Tool Accuracy - Heart Rate (MAPE)
- timeFrame
- Intraoperative period
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available