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
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.
Detection rate of pelvic metastatic disease in endometrial cancer
Incidence of lymphedema after removal of sentinel lymph nodes
Sentinel Lymph Node
Injection of tracer ( ICG) and detection of sentinel lymph nodes
Study Arms / Comparison Groups
Description: Pelvic SLN's defined by ICG injected cervically
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
Inclusion Criteria: - Women of age 18 years and older at the time of informed consent. - Women with a pathologically proven endometrial carcinoma of any histologic subtype or grade, clinically stage I-II planned for primary surgery - A uterine size allowing minimally invasive surgery - Women must be able to understand and sign an informed consent in Swedish language. - Absence of any exclusion criteria Exclusion Criteria: - Non consenting patients - Ongoing pregnancy - Inability to understand written and/or oral study information - WHO performance status or conditions contraindicating adjuvant oncological treatment (WHO III or more) - Previous lower limb lymphedema ( only for the lymphedema part of study) - Evidence of locally advanced disease or intraabdominal/distant metastases at preoperative CT, MRI or ultrasonography. - Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion. - Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion - Allergy to Iodine - Patients with a known liver disease - Patients with a bleeding disorder or mandatory antithrombotic treatment.
18 Years - 85 Years
Accepts Healthy Volunteers
Jan Persson, Ass Prof, 0046733522080, [email protected]
Jan Persson, Ass Prof, Principal Investigator, RegionSkane, department of OB&G, Skåne university hospital, Lund