Sentinel Lymph Node Detection in Endometrial Cancer

March 20, 2019 updated by: Region Skane

Near Infrared Fluorescent Technique for Sentinel Lymph Node Mapping in Endometrial Cancer

In endometrial cancer (EC) pelvic and paraaortic lymphadenectomy is performed only in high risk groups (with approximately 20% of patients having lymph node metastases (LNM)) whereas no lymphadenectomy is recommended in low risk groups despite 5% LNM. Moreover, preoperative risk group allocation is known to be erroneous in up to 15% of patients.

A technique identifying sentinel lymph nodes (SLN) in endometrial cancer have the potential to spare extensive surgery in 80% of high risk patients, identify low risk patients with nodal metastases, diminish side effects caused by full lymphadenectomy and render some expensive preoperative risk group allocation measures unnecessary.

A clinically useful SLN technique requires a high technical success rate, a clear definition of SLN, an algorithm taking into account that metastatic nodes not always accumulate tracer and a reproducible surgical algorithm. A definition of SLN requires knowledge on lymphatic anatomy. Unfortunately all tracers, dyes/radiotracers often result in an abundance of colored/ signaling nodes. Therefore, a definition of a SLN requires identification of efferent/afferent lymph vessels.

Several publications describe sentinel node techniques in EC with a variety of tracers (various dyes, radiotracer, alone or in combination). Sentinel nodes are usually described as "radioactive nodes" or "colored nodes" only with no further discrimination. No study relate to an anatomical description of lymphatic pathways.

The aims of this study is to systematically display the major anatomical pathways with the use of ICG and to evaluate a standardized and reproducible SLN surgical algorithm based on lymphatic anatomy and identification of efferent lymph vessels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endometrial cancer is an increasingly common gynecologic malignancy. The cumulative 5-year survival rate for node negative patients is 94%, 75% in those with metastatic pelvic lymph nodes only and 38% in patients with pelvic and paraaortic metastases. The proportion of node positive patients in adequately staged patient materials (usually high risk groups) is reported in the range of 15-21%. Depending on used risk criteria lymph node metastases occur in 1.5-7.8% in low risk patients. Some studies show better overall survival after pelvic and paraaortic lymphadenectomy, whereas other studies show increased complications with no survival benefit from the lymphadenectomy. Recent articles recommend paraaortic and pelvic lymp node metastases (LND) in high risk EC but the therapeutic value related to potential complications of nodal staging in EC is debated as well as how to define risk groups. An incidence of 0.9-5.2% severe lymphedema and 3.1% chylous ascites requiring treatment has been described after robotic pelvic and paraaortic lymphadenectomy.

The Sentinel node concept has been studied extensively in other cancer forms, for example breast and vulvar cancer. With the above mentioned controversy, patients with EC would benefit tremendously from a functioning Sentinel node concept. Studies using patent blue or radioactive tracer have not shown satisfactory results. The Da Vinci system (da Vinci® Surgical System, Intuitive Surgical Inc., Sunnyvale, Ca, USA) with Firefly technique could make a new concept possible in which major lymphatic drainage can be displayed and learned, hence allowing a standardization of SLN definitions. In our pilot studies, a reproducible surgical algorithm has been defined, overcoming and compensating the fact that ICG spreads quickly to several nodes.

Purpose: To develop a reliable Sentinel node Concept using the Firefly system with ICG in EC patients based on a defined lymphatic anatomy, a clear definition of a sentinel node and a reproducible surgical algorithm.

Hypothesis: The Firefly system using ICG enables the use of a Sentinel node concept in EC patients regardless risk group, so that only patients with pathologically proven lymph nodes metastases undergo a pelvic and paraaortic lymphadenectomy.

Methods of Research:

375 consecutive EC patients planned for robotic hysterectomy, bilateral salpingo-oophorectomy and in high risk patients also pelvic and paraaortic lymphadenectomy at Skane University Hospital, Lund, Sweden are enrolled in this study prospectively after giving written consent. The study is approved by the regional Institutional Review Board. With extended funding, the study will be expanded to another University Hospital in Sweden. Data on operative outcome, operative and postoperative complications, pathology reports and follow up for 24 months are prospectively collected. The use of Indocyanine green (ICG) and the Firefly system has the advantage of a fast uptake to lymphatic vessels and lymph nodes. Pilot studies have resulted in a new surgical method, standardization of operative technique and a clear definition of the Sentinel lymph node which now enables this study.

Study Type

Interventional

Enrollment (Actual)

257

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Planned robotic operation due to endometrial carcinoma
  • Patient suitable for laparoscopic surgery
  • Signed consent

Exclusion Criteria:

  • No consent
  • Inability to understand study information
  • surgical or anesthesiological contraindication for laparoscopic surgery
  • previous lymphatic problems
  • iodine allergy iodine
  • disseminated disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sentinel node procedure
Enrolling all eligible endometrial cancer patient to the Sentinel node concept using indocyanine green.
Procedure: Sentinel node procedure
Patients with Endometrial cancer undergo Sentinel node procedure using Indocyanine green
Other Names:
  • Indocyanine green

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of sentinel nodes
Time Frame: up to 2 months
The study measures the sensitivity of the described Sentinel node concept regarding the detection of Sentinel lymph nodes and detection of lymph node metastases
up to 2 months
Detection of Sentinel nodes
Time Frame: up to 2 months
The study measures the specificity of the described Sentinel node concept regarding the detection of Sentinel lymph nodes and detection of lymph node metastases
up to 2 months
Detection of Setinel nodes
Time Frame: up to 2 months
The study measures the false negative rate of the described Sentinel node concept regarding the detection of Sentinel lymph nodes and detection of lymph node metastases
up to 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rates
Time Frame: up to 24 months after inclusion
The study measures the recurrence rate after concluded treatment including the Sentinel node concept
up to 24 months after inclusion
Lymphatic complications
Time Frame: up to 24 months after inclusion
Comparison of the incidence of lymphatic complications such as lymph cysts and lymph edema after Sentinel node biopsy and full pelvic and paraaortic lymphadenectomy.
up to 24 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Study Director: Jan Persson, Ass Prof, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

May 30, 2018

Study Completion (Actual)

May 30, 2018

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

February 18, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Actual)

March 22, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RegionSkaneKKLund

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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