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Evaluation of Sentinel Node Policy in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence.
Sponsor: Centre Oscar Lambret
Summary
The aim of this trial is to evaluate the sentinel node policy in early stage endometrial carcinomas at intermediate and high risk of recurrence (by comparing the sentinel node policy to current initial staging protocols).
Official title: Randomized Trial Comparing Sentinel Node (SN) Policy to Current French Initial Staging Protocols in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
262
Start Date
2015-11
Completion Date
2027-10
Last Updated
2026-03-18
Healthy Volunteers
No
Interventions
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
Locations (16)
Polyclinique Urbain V
Avignon, France
Centre Hospitalier Régional Universitaire
Besançon, France
Institut Bergonié
Bordeaux, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Georges François Leclerc
Dijon, France
Centre Oscar Lambret
Lille, France
Hôpital Jeanne de Flandres, CHRU Lille
Lille, France
Hôpital Mère-Enfant, CHU Limoges
Limoges, France
Centre Léon Bérard
Lyon, France
Institut Paoli Calmettes
Marseille, France
ICM Val d'Aurelle
Montpellier, France
Hôpital La Pitié-Salpêtrière
Paris, France
Hôpital Européen Georges Pompidou
Paris, France
Institut de Cancérologie de l'Ouest, René Gauducheau
Saint-Herblain, France
Centre Paul Strauss
Strasbourg, France
Institut Claudius Regaud
Toulouse, France