Evaluation of Sentinel Node Policy in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence.

Korábbi kezelés

• Preoperative workup with :
  • Previous hysterectomy (by nature, this trial cannot be offered as a secondary staging procedure)
  • non carcinoma (for example sarcoma, trophoblastic tumor)
  • Low-risk endometrioid carcinoma as defined by the ESMO: 2009 FIGO stage IA grade 1-2
  • Metastatic disease at preoperative workup
  • Suspicious adenopathy at preoperative workup

Egyéb

• Pregnant and/or breastfeeding woman
• No understanding of the trial
• Patient deprived of liberty or in guardianship
• Inexperience of the trial site in pelvic sentinel node detection

• Patients with early endometrial carcinoma with early FIGO clinical stage I-II (clinical examination, abdomino-pelvic MRI/Ultrasound - or CT scan if MRI not possible - and endometrial biopsy or curettage), then stratification of the recurrence risk as defined by last European Society for Medical Oncology (ESMO) guidelines :
  • Intermediate-risk endometrioid (type 1): FIGO stage IA/T1a grade 3, or IB grade 1 or 2
  • Or High risk endometrioid (type 1) : FIGO stage IB/T1b grade 3, or II grade 1 or 2 or 3
  • Or High risk non endometrioid (type 2) : FIGO stages I-II
• Without any suspicious pelvic, paraaortic, distant node at preoperative MRI
• Age ≥ 18 years
• Performance status (OMS) ≤ 2
• No contraindication to surgery
• Absence of known hypersensitivity to colloidal rhenium sulphide and technetium (nanocolloid) or one of its excipients, to human albumin preparations, to Nanocoll® and Rotop-nanoHSA® and their excipients, to injectable dyes (blue dye or indocyanine green if available) or one of their excipients, to triphenylmethane derivatives
• Signed and dated informed consent
• Effective contraception for patients with reproductive potential
• Patient affiliated with a health insurance system