Informations générales (source: ClinicalTrials.gov)
(Sentimetre)
Observational
University Hospital, Strasbourg, France (Voir sur ClinicalTrials)
janvier 2017
juillet 2023
29 juin 2024
Selective lymphadenectomy Sentinel (LSS). This technique is already well established in
breast cancer and melanoma and more recently in vulvar and cervical cancer.
Compared to lymphadenectomy, it has several theoretical advantages:
- this is a sensitive technique with a detection rate of> 90% and a false negative
rate of <5%.
- the anatomopathological techniques used (immunohistochemistry with anti-cytokeratin
antibodies, serial sections) are more sensitive than the standard histological
analysis of lymphadenectomy, which allows an improvement in the detection of
metastases (micro-metastases, isolated tumor cells). In the SENTI-ENDO study, it was
possible to detect lymph node metastases in 11% of patients with low-risk
endometrial cancer and in 15% of intermediate-risk patients.
- it avoids short-term and long-term operative and post-operative morbidity of
lymphadenectomy.
Early studies of LSS in endometrial cancer demonstrated superior efficacy of the
colorimetric method coupled with the Technetium 99m isotopic method with an overall
detection rate of 78% [95% CI: 73-84]. The fluorescent green of indocyanine appears to
give better results with an overall detection rate of 94% and a bilateral detection rate
of 80%.
It seemed useful to take stock of this technique using this new dye.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Service de gynécologie-obstétrique - Hôpital de Hautepierre - 67091 - Strasbourg - France | Cherif Youssef AKLADIOS, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
- Major patient, without guardianship or curatorship.
- patient with endometrial cancer confirmed by biopsy.
- Invasive cancer stage FIGO I at intermediate risk and high risk and II according to
the FIGO classification.
- need for surgical staging.
- performing an endovaginal ultrasound or a pelvic MRI in preoperative, if
contraindication to MRI, performing a CT scan.
- subject affiliated to a social health insurance scheme.
- speaking and reading French.
- subject having dated and signed informed consent.
- Major patient, without guardianship or curatorship.
- patient with endometrial cancer confirmed by biopsy.
- Invasive cancer stage FIGO I at intermediate risk and high risk and II according to
the FIGO classification.
- need for surgical staging.
- performing an endovaginal ultrasound or a pelvic MRI in preoperative, if
contraindication to MRI, performing a CT scan.
- subject affiliated to a social health insurance scheme.
- speaking and reading French.
- subject having dated and signed informed consent.
- pregnancy in progress.
- FIGO III and IV stage diagnosed preoperatively or intraoperatively.
- Cure or pre-surgery that may alter the uterine lymphatic drainage (conization,
myomectomy).
- MRI or CT scan of suspected lymph nodes.