endometrial cancer uterine cancer
Conditions
Interventions
None listed
Sponsors
Diakonessenhuis Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The studie consists of two phases. - Inclusion criteria for phase 1: All women, suspicious for endometrial cancer, undergoing hysteroscopy and hysterectomy. - Inclusion criteria for phase 2: All women with high risk endometrial cancer, meaning that patients meet at least one of the following criteria: > 50% myometrial invasion differentiation grade 3 clearcell or serous papillary histology carcinosarcoma suspicious for extra-corporal spead
Exclusion criteria
Exclusion criteria: Patients with contraindications for open abdominal or laparoscopic surgery will be excluded: cervical or pelvic infection, severe cardio-pulmonal or other co-morbidity contra-indicating extensive surgery and anaesthesia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PRIMARY OUTCOME PHASE 1 Which technique is most accurate and/or feasible, when being used as a method mapping the lymph node drainage routes and sentinel nodes of the uterus? The two different techniques and drainage patterns will be compared to one and other. The main points of interest will be: - feasibility - patient friendliness - the location of the sentinel nodes (pelvic and/or para-aortal) - the level of para-aortal drainage (high and/or low) PRIMARY OUTCOME PHASE 2 - The number of sentinel nodes found after injection with Technetium 99m labelled nanocolloid and blue (= detection rate) - The reliability of the sentinel node procedure in high risk endometrial cancer, which will be determined by the false negative rate after histological examination of all removed nodes using the *gold standard* (= multiple sectioning and hematoxylin and eosin staining) - The feasibility and reliability of the OSNA CK 19 test as an in intraoperative method to diagnose lymph node macro- and micrometastasis in sentinel nodes of high risk endometrial cancer. Histopathological examination (H&E) will be used as control method. In case of discordant cases immunohistochemistry will be used as reference method. The reliability will be defined by the true histological false negative rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| SECONDARY OUTCOME PHASE 2 - Percentage of macro- and micrometastasis per lymph node station - Number of nodes removed by laparotomic versus laparoscopic staging - 5-Year recurrence free survival (RFS), disease specific (DSS) and overall survival (OS) of sentinel node negative versus sentinel node positive patients with high risk endometrial cancer (mainly those with micrometastasis) | — |
Countries
Netherlands
Outcome results
None listed