Sentinel node biopsy in Low- and Intermediate endometrial cancer Management
Recruiting
- Conditions
- Endometrial cancer (early stage)Sentinel lymph node Indocyanine green
- Registration Number
- NL-OMON22329
- Lead Sponsor
- Radboudumc
- Brief Summary
2020
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 142
Inclusion Criteria
Age 18 years
Histological confirmed endometrioid adenocarcinoma of the endometrium grade 1 or 2 on microcurettage
Exclusion Criteria
Patients with high-risk type 1 endometrial cancer stage (IB grade 3) or type 2 endometrial cancer (defined as > 10% of the specimen is serous or clear cell type) of any grade and stage.
Patients with intermediate- risk stage IA grade 3 type 1 endometrial cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients with a positive sentinel lymph node ( at least one macro- or micrometastasis) with a change in adjuvant therapy.
- Secondary Outcome Measures
Name Time Method 1.To evaluate the incidence of ITC, micro- and macrometastases<br /><br>2.To assess the detection rate of the SLN biopsy in one and two pelvic hemisphere<br /><br>3.To investigate if SLN biopsy in women with low- and intermediate-risk endometrial cancer will lead to better disease free and overall survival<br /><br>4. To assess if the presence of only ITC leads to more recurrences of disease<br /><br>5.To investigate the risks and complications of the SLN biopsy.<br>