Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04663412 |
| Other study ID # |
8337 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 9, 2020 |
| Est. completion date |
July 20, 2023 |
Study information
| Verified date |
December 2020 |
| Source |
Azienda Ospedaliera per l'Emergenza Canizzaro |
| Contact |
Paolo Scollo, Prof. |
| Phone |
0957262273 |
| Email |
paolo[@]scollo.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The potential of the administration of indocyanine green (ICG) allows the execution of SLN
biopsy, avoiding the multiple administrations of radiocolloid in the pre-operative phase,
painful for the patient, elimination, and exposure to radioactivity. Therefore, while
requiring standardization of the methodology and a large-scale application, this procedure
could open a new surgical management perspective in patients with early-stage vulvar cancer.
Description:
According to The European Society of Gynaecological Oncology (ESGO) guidelines, the
investigators decided to treat patients with vulvar squamous cell carcinoma (vSCC), FIGO
stage IB with radical vulvectomy, sentinel lymph node search, and removal with indocyanine
green (ICG) subsequent bilateral inguinofemoral lymphadenectomy.
Intraoperative imaging system The SPY Portable Handheld Imager (SPY-PHI) © Stryker was used
as the intraoperative imaging device. This device uses SPY fluorescence imaging technology to
visually assess blood circulation in blood vessels and associated tissue perfusion during
surgery. The design of SPY-PHI makes the device versatile, enabling the operator to frame the
operating field and use the acquired images in real-time, integrating fluorescence signal
data with white light images in real-time. The SPY Portable Handheld Imaging System Camera,
with integrated optics and cables for real-time fluorescence imaging in visible light and
near-infrared, is ideal for open surgery.
Intraoperative detection of the sentinel lymph node The fluorescent agent was administered to
patients placed in the lithotomy position under general anesthesia. Indocyanine green (ICG)
prepared with a 25 mg vial of green indocyanine green (ICG) (Pulsion Medical Systems AG,
Munich, Germany) diluted in 50 mL of water for injections (B. Braun Medical) was used,
resulting in a concentration of 0.5 mg/mL. Injection of 1 ml per quadrant was administered in
the three quadrants around the vulvar lesion. After the injection, the infrared camera,
equipped with a movable arm, was placed in front of the patient to detect transcutaneous
fluorescence during surgery. Subsequently, the SLN was localized based on the fluorescence
intensity. The intraoperative fluorescence detection camera system was used to open,
identify, and remove the SLN and the vulvectomy of the groin. After the excision, the capture
of the residual lymphatic pathway could be seen bilaterally through the infrared camera.
Additionally, all SLNs were subject to ex vivo imaging due to the presence of fluorescence.
The excised SLNs were sent to pathological anatomy and processed according to the standard
SLN protocol.
