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This study is exploring whether it's possible to detect paragangliomas (a rare type of tumor) during minimally invasive surgery by using a technique called near-infrared fluorescence imaging, guided by a substance called indocyanine green (ICG). The goal is to see if this method can help surgeons identify and treat paragangliomas more accurately and during minimally invasive procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective intervention cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorescence guided identification using indocyanine green | Drug | During minimally invasive surgery using intravenous administration of indocyanine green (ICG) near-infrared fluorescence imaging will be applied to identify and treat paragangliomas |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of real-time in-vivo identification of suspected paraganglioma's using Near-Infrared-fluorescence ICG imaging | The primary outcome of this retrospective study is the ability to visually detect the proportion (%) of suspected pre-operatively identified lesions (paraganglioma) in the abdomen during minimally invasive procedures using Near-Infrared-fluorescence ICG imaging | perioperatively/periprocedurally, within 30 minutes after intravenous administration of the fluorescent dye, up until a maximum of 120 minutes after start of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of the detection of suspected lesions using Near-Infrared-fluorescence ICG imaging | The secondary outcome of this retrospective study is the accuracy, measured by sensitivity and specificity to identify abdominal paragangliomas using using Near-Infrared-fluorescence ICG imaging | Postoperatively, at the moment the definitive pathology result is known, approximately five days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients >18yo diagnosed with abdominal paragangliomas which underwent surgical resection
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martijn van Dam, MD | Contact | 0715298420 | m.a.van_dam@lumc.nl | |
| Alexander L. Vahrmeijer, MD, PhD | Contact | a.l.vahrmeijer@lumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Recruiting | Leiden | 2300RC | Netherlands |
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| ID | Term |
|---|---|
| D010235 | Paraganglioma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |