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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sentinel Lymph Node Detection in Endometrial Cancer: A Consolidation Study

Conditions
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Sentinel Lymph Node, Endometrial Cancer, Lymphedema

Intervention / Treatment
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* Procedure: Injection of tracer ( ICG) and detection of sentinel lymph nodes


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SLN only<br>Pelvic SLN's defined by ICG injected cervically | Procedure: Injection of tracer ( ICG) and detection of sentinel lymph nodes<br>* Pelvic SLN's defined by ICG injected cervically<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 3 years from start inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of lymphedema after removal of sentinel lymph nodes | Objective measurement lymphedema defined by of leg volume before and after surgery | 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 | 3 years from start inclusion or after 150 patients if study stopped at interim analysis |