44
Participants
Start Date
September 6, 2023
Primary Completion Date
March 31, 2026
Study Completion Date
March 31, 2028
Robot-assisted ICG-guided sentinel lymph node biopsy
The robot-assisted ICG-guided sentinel node (SN) biopsy is conducted as follows: At the start of the operation, indocyanine green (ICG) solution is transscrotally injected into the testicular parenchyma. The patient is positioned in the nephrectomy posture. After port placement and docking of the robotic system, the sentinel node(s) should be visible with the fluorescence camera. The SN is removed and sent for immediate frozen section biopsy evaluation. The inguinal orchiectomy is performed subsequently until the biopsy results are available. If the biopsy is negative, the procedure concludes. If the biopsy shows viable tumor, indicating clinical stage IIA and the indication for systematic unilateral retroperitoneal lymph node dissection. The patient was informed about the potential expansion of the procedure upon study enrollment. After the procedure, all patients are placed under observation and do not receive adjuvant systemic treatment. The follow-up period extends to 2 years.
RECRUITING
University Hospital of Duesseldorf, Düsseldorf
Collaborators (1)
Intuitive Foundation
UNKNOWN
Heinrich-Heine University, Duesseldorf
OTHER