Endometrial Cancer
Conditions
Keywords
Cervical injection, Hysteroscopic injection
Brief summary
Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer: a multicenter prospective randomized study
Detailed description
Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer
Interventions
PROCEDUREHysteroscopic injection
Hysteroscopic injection
PROCEDURECervical injection
Cervical injection
Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consent from the patient; * Histological diagnosis of endometrial cancer (including type I and II EC); * Early stage (FIGO stage \< 4); * Age older than 18 years.
Exclusion criteria
* Preoperative diagnosis of extra-uterine disease; * Preoperative suspicious of gross positive nodes; * Execution of neoadjuvant chemotherapy; * Contraindication to upfront general anesthesia and or mini-invasive surgery; * Systemic infections ongoing; * Pregnancy ongoing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate | 30 month | assessment of Detection rate in the para-aortic area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate | 30 month | Detection rate in the pelvic area |
| Operative time | 30 month | Operative time to detect and remove sentinel node |
| Intraoperative complications | 30 month | Intraoperative complications during the sentinel lymph node dissection |
| Postoperative complications | 30 month | Postoperative complications graded per the Clavien-Dindo Classification system |
Countries
Italy
Outcome results
None listed