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

Overview

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

Full Title of Study: “Sentinel Lymph Node Detection in Endometrial Cancer: A Consolidation Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2022

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.

Interventions

  • Procedure: Injection of tracer ( ICG) and detection of sentinel lymph nodes
    • Pelvic SLN’s defined by ICG injected cervically

Arms, Groups and Cohorts

  • Experimental: SLN only
    • Pelvic SLN’s defined by ICG injected cervically

Clinical Trial Outcome Measures

Primary Measures

  • Detection rate of pelvic metastatic disease in endometrial cancer
    • Time Frame: 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
  • Operative time used for the study intervention ( injection of ICG and identification and removal of sentinel lymph nodes
    • Time Frame: 3 years from start inclusion
    • Exact measurements of time allocated for the SLN procedure as such.

Secondary Measures

  • Incidence of lymphedema after removal of sentinel lymph nodes
    • Time Frame: 4 years including at least one year follow up
    • Objective measurement lymphedema defined by of leg volume before and after surgery
  • intraoperative adverse events associated with the study intervention
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Region Skane
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jan Persson, Ass Prof, Principal Investigator, RegionSkane, department of OB&G, Sk√•ne university hospital, Lund
  • Overall Contact(s)
    • Jan Persson, Ass prof, 0046733522080, jan.persson@med.lu.se

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