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

NCT ID: NCT03838055

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 362 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2023-12-31

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.

Conditions

Sentinel Lymph Node; Endometrial Cancer; Lymphedema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

SLN only

Pelvic SLN's defined by ICG injected cervically

Group Type: EXPERIMENTAL

Injection of tracer ( ICG) and detection of sentinel lymph nodes

Intervention Type: PROCEDURE

Pelvic SLN's defined by ICG injected cervically

Interventions

Injection of tracer ( ICG) and detection of sentinel lymph nodes

Pelvic SLN's defined by ICG injected cervically

Intervention Type: PROCEDURE

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Persson, Ass Prof

Role: PRINCIPAL_INVESTIGATOR

RegionSkane, department of OB&G, Skåne university hospital, Lund

Locations

Department of Gynecology and Obstetrics

Lund, , Sweden

Countries

Sweden

Central Contacts

Jan Persson, Ass prof

Role: CONTACT

jan.persson@med.lu.se

0046733522080

Michele Bollino, MD

Role: CONTACT

michele.bollino@med.lu.se

0046723059274

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RegionSkaneKKLund3

Identifier Type: -

Identifier Source: org_study_id