Robot-assisted ICG-guided Sentinel Node Biopsy in Testicular Cancer

NARecruitingINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

September 6, 2023

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2028

Conditions
Germ Cell TumorSeminomaNonseminomatous Germ Cell Tumor
Interventions
PROCEDURE

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.

Trial Locations (1)

Unknown

RECRUITING

University Hospital of Duesseldorf, Düsseldorf

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Intuitive Foundation

UNKNOWN

lead

Heinrich-Heine University, Duesseldorf

OTHER