An interventional study of Injection of tracer ( ICG) and detection of sentinel lymph nodes in Sentinel Lymph Node, Endometrial Cancer and Lymphedema, sponsored by Region Skane. Status unknown at 1 site in Sweden. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-02-12.
Sponsored by Region Skane · Not applicable, Interventional, and Diagnostic
Evaluation of removal of Sentinel lymph nodes only for detection of pelvic lymph node metastases in high risk and low risk endometrial cancer.
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.
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's planned enrollment of 362 is above the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pelvic SLN's defined by ICG injected cervically
Procedure: Injection of tracer ( ICG) and detection of sentinel lymph nodes
Pelvic SLN's defined by ICG injected cervically
Detection rate of pelvic metastatic disease in endometrial cancer
The detection rate will be evaluated from a non-inferiority perspective based on a null-hypothesis of 4% less than an expected rate of 12% nodal metastases
Time frame: 3 years from start inclusion with an interim analysis after 150 patients
Operative time used for the study intervention ( injection of ICG and identification and removal of sentinel lymph nodes
Exact measurements of time allocated for the SLN procedure as such.
Time frame: 3 years from start inclusion
Incidence of lymphedema after removal of sentinel lymph nodes
Objective measurement lymphedema defined by of leg volume before and after surgery
Time frame: 4 years including at least one year follow up
intraoperative adverse events associated with the study intervention
Detailed registration of adverse events associated with the SLN procedure as such
Time frame: 3 years from start inclusion or after 150 patients if study stopped at interim analysis
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This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Region Skane