Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2026-04-01

Brief Summary

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Assessment of accuracy of sentinel node biopsy, defined as the false negative rate.

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Detailed Description

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Current practice in patients with Clinical Stage I (CS I) testicular germ cell tumour is active surveillance after orchiectomy, with relapses occurring in 15-20% of patients. The majority of relapses occur in the lymph nodes as lymphogenic spread is the dominant route of dissemination. A sentinel node procedure, in which the sentinel lymph node is resected and pathologically examined, could be more reliable to identify patients who are likely to relapse.

Early identification of patients with micro-metastases in the sentinel node makes it possible to treat these patients at the earliest possible moment. Absence of metastases could lead in the future to a less intensive follow up protocol than the present one.

Conditions

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Testicular Germ Cell Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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sentinel node procedure

a robot-assisted laparoscopic sentinel node procedure.

sentinel node procedure

Intervention Type PROCEDURE

a robot-assisted laparoscopic sentinel node procedure to detect occult lymph node metastasis

Interventions

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sentinel node procedure

a robot-assisted laparoscopic sentinel node procedure to detect occult lymph node metastasis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients suspected of testicular germ cell tumour, based on physical examination, ultrasound imaging, and tumour markers
* Patients 18 years and older
* No evidence of metastases on first staging (thoraco-abdominopelvic CT)
* Written and signed informed consent

Exclusion Criteria

* Patients with evidence of metastases at first staging
* Patients with a second primary tumour
* Patients with recent (\< 6 months before diagnosis) surgical treatment to the external genitals or recent surgical intervention in the inguinal or retroperitoneal regions
* Patients with previous abdominal surgery, necessitating open surgical approach for the sentinel node biopsy

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No