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

Not Applicable

• Conditions: Endometrial Cancer; Sentinel Lymph Node; Lymphedema

• Registration Number: NCT03838055
• Lead Sponsor: Region Skane

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-12-21
• Status Verified: 2019-01
• Study Start: 2019-02
• Study First Submitted QC: 2019-02-08
• Last Update Submitted: 2019-02-08
• Study First Posted: 2019-02-12
• Last Update Posted: 2019-02-12
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 362

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Operative time used for the study intervention ( injection of ICG and identification and removal of sentinel lymph nodes	3 years from start inclusion	Exact measurements of time allocated for the SLN procedure as such.
Detection rate of pelvic metastatic disease in endometrial cancer	3 years from start inclusion with an interim analysis after 150 patients	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

Secondary Outcome Measures

Name	Time	Method
intraoperative adverse events associated with the study intervention	3 years from start inclusion or after 150 patients if study stopped at interim analysis	Detailed registration of adverse events associated with the SLN procedure as such
Incidence of lymphedema after removal of sentinel lymph nodes	4 years including at least one year follow up	Objective measurement lymphedema defined by of leg volume before and after surgery

Trial Locations

Locations (1)

Department of Gynecology and Obstetrics; 🇸🇪 Lund, Sweden