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.

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.