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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lymphedema; Endometrial Cancer; Sentinel Lymph Node
• Intervention / Treatment: Procedure: Injection of tracer ( ICG) and detection of sentinel lymph nodes

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 Type: Interventional
• Enrollment (Anticipated): 362
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Persson, Ass prof; Phone Number: 0046733522080; Email: jan.persson@med.lu.se
• Study Contact Backup: Name: Michele Bollino, MD; Phone Number: 0046723059274; Email: michele.bollino@med.lu.se

Study Locations

• Sweden
  • Lund, Sweden, 22185
    • Department of Gynecology and Obstetrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Jan Persson, Ass Prof, RegionSkane, department of OB&G, Skåne university hospital, Lund

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 21, 2018
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Lymphatic Diseases; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Lymphedema; Endometrial Neoplasms
• Other Study ID Numbers: RegionSkaneKKLund3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No