Minimally-invasive ICG-guided Retroperitoneal Sentinel Lymph Node Dissection in the Primary Staging of Testicular Cancer Versus Standard of Care

Testicular cancer is highly curable, but approximately 20-30% of patients with clinical stage I disease harbor occult retroperitoneal lymph node metastases that are not detected by conventional imaging. Current risk-adapted management may lead to overtreatment in some patients while failing to identify others who are at increased risk of relapse. The RAISN 2 study evaluates whether minimally invasive indocyanine green (ICG)-guided retroperitoneal sentinel lymph node dissection can improve primary staging and risk stratification in patients with clinical stage I testicular cancer. Participants will be randomized in a 5:1 ratio to undergo either orchiectomy combined with ICG-guided sentinel lymph node dissection or standard orchiectomy followed by guideline-based surveillance. All participants will undergo structured follow-up according to current clinical guidelines. The primary objective is to estimate the 2-year relapse-free survival of patients undergoing the sentinel lymph node approach. Secondary objectives include assessment of overall survival, relapse patterns, perioperative morbidity, quality of life, psychological outcomes, and the feasibility and safety of the procedure. This multicenter study aims to determine whether sentinel lymph node-guided staging provides more accurate risk stratification while avoiding unnecessary treatment and maintaining oncological safety.

Sex

Male

Minimum age

18 Years

Inclusion Criteria:

* Male participants aged 18 years or older.
* Clinically suspected testicular germ cell tumor based on physical examination and scrotal ultrasonography, with or without elevated serum tumor markers (AFP and/or β-hCG).
* No radiological evidence of metastatic disease on preoperative contrast-enhanced computed tomography (CT) of the chest and abdomen (clinical stage I).
* Eligible for radical inguinal orchiectomy.
* Able to understand the study procedures and provide written informed consent.
* Willing and able to comply with the study protocol and follow-up schedule.

Exclusion Criteria:

* Previous scrotal or retroperitoneal surgery unrelated to germ cell tumor treatment, except surgery for cryptorchidism during childhood.
* Previous malignancy requiring abdominal surgery, chemotherapy, or radiotherapy that could interfere with study participation.

Previous radiotherapy involving the retroperitoneum.

* Known hypersensitivity to indocyanine green (ICG), iodine, or sodium iodide.
* Severe medical condition that precludes surgery or study participation.
* Psychiatric disorder or other condition preventing compliance with study procedures.
* Inability to understand the German language sufficiently to provide informed consent and complete study assessments.
* Individuals under legal guardianship or otherwise unable to provide legally valid informed consent.

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