title: 10-Year experience regarding the reliability and morbidity of radio guided lymph node biopsy in penile cancer patients and the associated radiation exposure of medical staff in this procedure.
abstract: BACKGROUND
  The guidelines of the European Association of Urologists (EAU), of the German Society of Nuclear Medicine (DGN), and the European Society for Medical Oncology (ESMO) recommend sentinel lymph node biopsy (SLNB) for lymph node staging in penile cancer with non-palpable inguinal lymph nodes as one diagnostic method. Despite this, the method is neither widely nor regularly applied in Germany - the same applies to many other countries, which may be due to insecurity in dealing with open radioactive tracers. This study aims to assess the reliability and morbidity of this method, as well as the associated radioactive burden for clinical staff.
  
  
  METHODS
  Between 2006 and 2016, 34 patients with an invasive penile carcinoma and inconspicuous inguinal lymph node status underwent SLNB in 57 groins after application of a radiotracer (Tc-99 m nanocolloid). We collected the results prospectively. The reliability of the method was assessed by determining the false-negative rate. In addition, we evaluated complication rates and determined the radioactive burden for the clinical staff both pre- and intraoperatively.
  
  
  RESULTS
  SLNB was performed in 34 patients with penile cancer with non-palpable inguinal lymph nodes in 57 groins. In two patients inguinal lymph node metastases were detected by means of SLNB. In one patient recurrent inguinal lymph node disease was found after negative SLNB in both groins. Thus, the false negative rate was 3.13 % per patient (1/32 patients) and 3.51 % per groin (2/57 groins). The morbidity rate was 2.94 % per patient (1/34 patients) and 1.75 % per groin (1/57 groins). Radiation exposure for the clinical staff during this procedure was low at a maximum of ca. four μSV per intervention.
  
  
  CONCLUSIONS
  SLNB is a reliable method with low morbidity that is associated with a low radiation burden for clinical staff. Due to the enhanced methodological and logistic demands, this intervention should be performed in specialized centres and in an interdisciplinary approach.
authors.affiliation: Department of Nuclear medicine, Molecular Imaging Diagnostics and Therapy, University Hospital Schleswig Holstein, Campus Kiel, Kiel, Germany. uluetzen@nuc-med.uni-kiel.de.
authors.forename: Ulf
authors.identifier: http://orcid.org/0000-0001-8483-5280
authors.initials: U
authors.lastname: Lützen
authors.affiliation: Department of Urology and Pediatric Urology, University Hospital Schleswig Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Carsten Maik
authors.initials: CM
authors.lastname: Naumann
authors.affiliation: Northern German Seminar for Radiation Protection gGmbH at the Christian-Albrechts-University Kiel, Kiel, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Dischinger
authors.affiliation: Department of Nuclear medicine, Molecular Imaging Diagnostics and Therapy, University Hospital Schleswig Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Marlies
authors.initials: M
authors.lastname: Marx
authors.affiliation: Department of Radio Oncology, University Hospital Schleswig Holstein, Campus Kiel, Kiel, Germany.
authors.forename: René
authors.initials: R
authors.lastname: Baumann
authors.affiliation: Department of Nuclear medicine, Molecular Imaging Diagnostics and Therapy, University Hospital Schleswig Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Yi
authors.initials: Y
authors.lastname: Zhao
authors.affiliation: Department of Nuclear medicine, Molecular Imaging Diagnostics and Therapy, University Hospital Schleswig Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Jüptner
authors.affiliation: Department of Urology and Pediatric Urology, University Hospital Schleswig Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Daniar
authors.initials: D
authors.lastname: Osmonov
authors.affiliation: Department of Urology and Pediatric Urology, University Hospital Schleswig Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Katrin
authors.initials: K
authors.lastname: Bothe
authors.affiliation: Department of Urology and Pediatric Urology, University Hospital Schleswig Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Klaus-Peter
authors.initials: KP
authors.lastname: Jünemann
authors.affiliation: Department of Nuclear medicine, Molecular Imaging Diagnostics and Therapy, University Hospital Schleswig Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Maaz
authors.initials: M
authors.lastname: Zuhayra
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006801:Humans; D008297:Male; D008503:Medical Staff; D008875:Middle Aged; D016273:Occupational Exposure; D010412:Penile Neoplasms / Q000473:pathology*; D000069079:Radiation Exposure / Q000009:adverse effects*; D011877:Radionuclide Imaging / Q000009:adverse effects; D019275:Radiopharmaceuticals / Q000009:adverse effects*; D015203:Reproducibility of Results; D021701:Sentinel Lymph Node Biopsy / Q000009:adverse effects* / Q000379:methods*; D013668:Technetium Tc 99m Aggregated Albumin / Q000009:adverse effects*; D013997:Time Factors
chemical_list: D019275:Radiopharmaceuticals; D013668:Technetium Tc 99m Aggregated Albumin; C083602:technetium Tc 99m nanocolloid
keywords: Lymph node staging; Penile carcinoma; Radiation exposure; SPECT/CT; Sentinel lymph node biopsy; Sentinel lymph nodes; Tc 99 m-nanocolloid