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

Region Skane

Status

Unknown

Conditions

Endometrial Cancer

Sentinel Lymph Node

Lymphedema

Treatments

Procedure: Injection of tracer ( ICG) and detection of sentinel lymph nodes

Study type

Interventional

Funder types

Other

Identifiers

NCT03838055

RegionSkaneKKLund3

Details and patient eligibility

About

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

Full 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.

Enrollment

362 estimated patients

Sex

Female

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.