262
Participants
Start Date
November 30, 2015
Primary Completion Date
October 31, 2024
Study Completion Date
October 31, 2027
Pre-operative SN mapping with radionucleide
"1. Preparation : four 1ml syringe (Nanocis, or Nanocoll, or Rotop-nanoHSA) are prepared per patient, each containing a total activity 10 MBq if the injection is planned the same day of surgery and in the operative theater OR each containing a total activity 30MBq if the injection is performed the day before the surgery.~2. Intracervical injection is performed by the surgeon, no more than 3-24 hours before surgery : 4 submucous injections with the filtered radiocolloid at 3, 6, 9 and 12 o'clock positions. Each injection if performed at 2 mm of depth for a total activity of 40 MBq or a total activity of 120 MBq is the surgery is planned the day after the injection.~3. Sentinel Node detection by planar scintigraphy at 1 and 3h (if no detection at 1 hour), or by SPECT-CT imaging if available."
Intra-operative SN mapping with patent V blue dye
"1. Patent blue V dye are diluted with saline sterile solution to obtain 4ml of 50%. Four 1ml syringe, each containing a 50% patent blue dye solution, are prepared per patient.~2. Intracervical injection is performed by the surgeon. after anesthesis induction and incising the skin,under laparoscopic / laparotomy control to detect intraperitoneal injection of the tracer. Sub-mucous injections are performed with 50% diluted dye at 3 and 9 o'clock positions. At each positions : 1ml is injected deep into the stroma of the cervix (1cm), another 1ml is injected superficially (at 2mm depth). The time between the injection of the dye and the search for the SN must be as shortest as possible.~3. SN are detected by direct visualization of blue colored lymphatics and node"
Intra-operative SN mapping with indocyanin green
"1: Infracyanine powder is diluted in aqueous sterile water to obtain 4ml with a concentration of 1.25 mg/mL. Four 1ml syringe, each containing a 1.25 mg/mL Infracyanine dye solution, are prepared per patient.~2- Intracervical injection is performed by the surgeon, after anesthesis induction and incising the skin,under laparoscopic / laparotomy control to detect intraperitoneal injection of the tracer. Sub-mucous injections are performed with 50% diluted dye at 3 and 9 o'clock positions. At each positions : 1ml is injected deep into the stroma of the cervix (1cm), another 1ml is injected superficially (at 2mm depth). The time between the injection of the dye and the search for the SN must be as shortest as possible~3- SN detection by near-infrared fluorescence imaging"
Full bilateral laparoscopic lymphadenectomy and Hysterectomy
"* Bilateral pelvic lymphadenectomy (intermediate risk endometrioid)~* Or Ilio-infrarenal paraaortic lymphadenectomy (high risk endometrioid)~* Or Pelvic + paraaortic lymphadenectomies (high risk non endometrioid)"
Current initial staging protocols
Current French initial staging protocols
Institut Paoli Calmettes, Marseille
Centre Hospitalier Régional Universitaire, Besançon
Institut Claudius Regaud, Toulouse
Institut Bergonié, Bordeaux
ICM Val d'Aurelle, Montpellier
Institut de Cancérologie de l'Ouest, René Gauducheau, Saint-Herblain
Centre Oscar Lambret, Lille
Hôpital Jeanne de Flandres, CHRU Lille, Lille
Centre Jean Perrin, Clermont-Ferrand
Centre Paul Strauss, Strasbourg
Centre Léon Bérard, Lyon
Hôpital La Pitié-Salpêtrière, Paris
Hôpital Européen Georges Pompidou, Paris
Polyclinique Urbain V, Avignon
Hôpital Mère-Enfant, CHU Limoges, Limoges
Centre Georges François Leclerc, Dijon
National Cancer Institute, France
OTHER_GOV
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Canceropôle Nord Ouest
OTHER
Centre Oscar Lambret
OTHER