NCT03838055

Sentinel Node Detection in Endometrial Cancer: A Consolidation Study on Detection Rates of Metastatic Disease

Sentinel Lymph Node Detection in Endometrial Cancer: A Consolidation Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 362 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of removal of Sentinel lymph nodes only for detection of pelvic lymph node metastases in high risk and low risk endometrial cancer.

Detailed 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 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.

Conditions

• Sentinel Lymph Node
• Endometrial Cancer
• Lymphedema

Interventions

Type	Name	Description
PROCEDURE	Injection of tracer ( ICG) and detection of sentinel lymph nodes	Pelvic SLN's defined by ICG injected cervically

Timeline

• Start date: 2019-02-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2019-02-12
• Last updated: 2019-02-12

Locations

1 site across 1 country: Sweden