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

Endometrial Cancer Clinical Trial

Official title:

Sentinel Lymph Node Detection in Endometrial Cancer: A Consolidation Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03838055
• Other study ID #: RegionSkaneKKLund3
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2019
• Est. completion date: December 2023

Study information

• Verified date: January 2019
• Source: Region Skane
• Contact: Jan Persson, Ass prof
• Phone: 0046733522080
• Email: jan.persson[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 362
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Lymphedema
• Sentinel Lymph Node

Intervention

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

Locations

Country	Name	City	State
Sweden	Department of Gynecology and Obstetrics	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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