(high risk) endometrial cancer
Conditions
Interventions
None listed
Sponsors
Diakonessenhuis Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: This study is a multicenter cross-sectional diagnostic invention study, consisting of two sub-studies. ;Inclusion criteria PART I: ====================;All women, undergoing a hysteroscopic curettage and a hysterectomy because of suspicion for a (malignant) lesion of the endometrium.;Inclusion criteria PART II: ====================;Only patients with high risk endometrial cancer will be included in this study, because - according to the recently revised national guideline - standard care in these patients includes a pelvic and para-aortal lymphadenctomy. High risk patients are defined as having at least one of the following characteristics: differentiation grade 3, > 50% myometrial invasion, suspicious for extra-corporal spread, high risk histological type (serous papillary, clear cell or carcinosarcoma tumour type)
Exclusion criteria
Exclusion criteria: Exclusion criteria PART I and PART II: ==============================;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 parameter PART I ============================ Both techniques will be compared for: - sentinel node detection rate (min. 80% DR) - the location and level of the sentinel nodes (pelvic and/or para-aortal, high and/or low) - patient friendliness (questionnaire) - doctor friendliness (questionnaire) Primary outcome parameter PART II ============================ 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 Hematoxylin and Eosin (H&E) staining and immunohistochemistry (IHC)) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters PART II: ================================ 1) The prevalence location of lymphnode metastasis (pelvic and/o high/low para-aortal). 2) The prevalence of lymphnode micrometastasis in high risk endometrial cancer. 3) The feasibility and reliability of the OSNA CK19 test as an intraoperative method to diagnose lymph node macro- and micrometastasis in sentinel nodes will be tested. 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. | — |
Countries
Netherlands
Outcome results
None listed