Selective Surgical Staging for the Treatment of Endometrial Cancer Based on Intraoperative Consultation
NCT02658565 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 401
Last updated 2026-01-22
Summary
Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical staging for endometrial cancer increases operative time and surgical morbidity, but appears to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic approach has not been reproduced, and the investigators propose to validate their algorithm at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the investigators are well-suited to perform this investigation. A surgical approach that is tailored to the patient's cancer biology is rational, supported by the recent literature, and medically compelling since the co-morbidities of many obese, low-risk EC patients put them at significantly increased perioperative risk for complete lymphadenectomy.
Conditions
Interventions
- PROCEDURE
-
Lymphadenectomy
Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes
Sponsors & Collaborators
-
Frederick R. Ueland, M.D.
lead OTHER
Principal Investigators
-
Frederick Ueland, M.D. · University of Kentucky
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-29
- Primary Completion
- 2023-12-08
- Completion
- 2026-11-30
Countries
- United States
Study Locations
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