Endometrial Cancer, Lymphedema, Sentinel Lymph Node
Conditions
Brief summary
Evaluation of removal of Sentinel lymph nodes only for detection of pelvic lymph node metastases in high risk and low risk endometrial cancer.
Detailed description
Consecutive patients with- and low risk endometrial cancer will be approached for eligibility for inclusion in a study evaluating the detection rates of pelvic metastatic disease by detection and removal of Sentinel lymph nodes only, i.e with no further lymphadenectomy. A re-staging will be performed in case of metastatic Sentinel lymph nodes to guide adjuvant treatment. The detection rate will be evaluated from a non-inferiority perspective against the expected rate of nodal metastases based on detailed final histological data. Adverse events related the intervention ( Injection of tracer (ICG) and removal of sentinel nodes), time for the intervention, and an objective evaluation of lymphatic complications (lymphoedema) will be performed in addition to the use of a validated lymphoedema QOL questionnaire.
Interventions
PROCEDUREInjection of tracer ( ICG) and detection of sentinel lymph nodes
Pelvic SLN's defined by ICG injected cervically
Sponsors
Region Skane
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Prospective cohort study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Women of age 18 years and older at the time of informed consent. * Women with a pathologically proven endometrial carcinoma of any histologic subtype or grade, clinically stage I-II planned for primary surgery * A uterine size allowing minimally invasive surgery * Women must be able to understand and sign an informed consent in Swedish language. * Absence of any
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate of pelvic metastatic disease in endometrial cancer | 3 years from start inclusion with an interim analysis after 150 patients | The detection rate will be evaluated from a non-inferiority perspective based on a null-hypothesis of 4% less than an expected rate of 12% nodal metastases |
| Operative time used for the study intervention ( injection of ICG and identification and removal of sentinel lymph nodes | 3 years from start inclusion | Exact measurements of time allocated for the SLN procedure as such. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of lymphedema after removal of sentinel lymph nodes | 4 years including at least one year follow up | Objective measurement lymphedema defined by of leg volume before and after surgery |
| intraoperative adverse events associated with the study intervention | 3 years from start inclusion or after 150 patients if study stopped at interim analysis | Detailed registration of adverse events associated with the SLN procedure as such |
Countries
Sweden
Contacts
Primary ContactJan Persson, Ass prof
Backup ContactMichele Bollino, MD
Outcome results
None listed