Sentinel Node Detection in Endometrial Cancer: A Consolidation Study on Detection Rates of Metastatic Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Endometrial Cancer
- Lymphedema
- Sentinel Lymph Node
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Prospective cohort studyMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Only males
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 performe...
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.
Tracking Information
- NCT #
- NCT03838055
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jan Persson, Ass Prof RegionSkane, department of OB&G, Skåne university hospital, Lund
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