1. Lymphatic route of endometrial cancer dissemination (Time Frame - 1 month): Comparing the per-operative anatomical locations of uterine SLNs depending on the 3 different injection sites of the tracers: whether in endometrium, in uterine isthmus or in the cervix.
Secondary outcome:
1. Sensibility/sensitivity of the tracers (Time Frame - 1 month): A comparison of the sensibility/sensitivity of the tracers to detect SLNs
2. Adverse events (Time Frame - 1 month): A description of the incidence of adverse events
3. Additional time required to identify SLNs (Time Frame - 1 month): An evaluation of additional time required to identify SLNs with or without lymph node dissection.
4. Morbidity directly induced by the search of SLNs (Time Frame - 1 month): A description of morbidity grades (following the NCI CTCAE classification) directly induced by the search of SLNs
5. Negative predictive value of the different markers (Time Frame - 1 month): A calculation of negative predictive value of the different markers and their associations
6. Correlation between the per-operative anatomical locations of the SLNs and ultrastadification of SLNs. (Time Frame - 1 month): A correlation between the per-operative anatomical locations of the SLNs and the results of ultrastadification of these SLNs.
7. Comparison between the results of lymphatic drainage and location of the tumor. (Time Frame - 1 month): An evaluation of the anatomical location of the SLNs depending on uterine location of the tumor.
The anatomical locations would be divided in 3 different sites: pelvic, para-aortic and parametrial.
The location of the tumor would be divided in 3 sites: uterine horns, uterine fundus, uterine walls.
8. Comparison between the results of lymphatic drainage and grade of the tumor. (Time Frame - 1 month): An evaluation of the anatomical location of the SLNs depending on grade of the tumor.
The anatomical locations would be divided in 3 different sites: pelvic, para-aortic and parametrial.
The location of the tumor would be divided in 3 grades: 1, 2 and 3
9. Cases with change in treatment in relation with SLNs detection and histology. (Time Frame - 1 month): Description of cases wherein change in the treatment have been made related to results of different anatomical locations and pathological (including ultrastadification) results of SLNs.
Lymphatic drainage of endometrial cancer: Nanocoll® is injected a day before surgery in the cervix at four points. A lymphoscintigraphy is performed 2 or 3 hours afterward. At the beginning of the surgery, the operative field already in place and before the beginning of laparoscopic, 2ml (10mg) of ICG, distributed in four points around the tumor, is injected under the endometrium intra-myometrial under endoscopic control. As ICG spreads slower than blue dye, ICG is always injected first. Then, Bleu Patenté® is injected at two sites in the uterine isthmus, opposite of the uterine arteries. The risk of false negative results, because a tracer migrated too quickly, is reduced when the injection takes place when patients are already anesthetized.
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"A Prospective Study Comparing Three Injection Sites to Detect Sentinel Lymph Nodes in Endometrial Cancer"
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