NCT01512810

Intraoperative Pathological Evaluation for Surgical Treatment & Staging for Endometrial Cancer

Treatment of Endometrial Cancer Utilizing Pathology Intraoperative Consultation to Determine Extent of Surgical Staging

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Frederick R. Ueland, M.D. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Endometrial Cancer

Interventions

Type	Name	Description
PROCEDURE	Lymphadenectomy	Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes

Timeline

• Start date: 2012-01-01
• Primary completion: 2021-08-26
• Completion: 2021-08-26
• First posted: 2012-01-19
• Last updated: 2021-11-24

Locations

1 site across 1 country: United States