NCT02690259

Sentinel Lymph Node Detection in Endometrial Cancer

Completed NA Last updated 22 March 2019

What this trial tests

NA trial testing Sentinel node procedure in Endometrial Neoplasms in 257 participants. Completed in 30 May 2018.

Timeline

1 June 2014

Primary endpoint
30 May 2018

30 May 2018

Quick facts

Lead sponsor	Region Skane
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	257
Start date	1 June 2014
Primary completion	30 May 2018
Estimated completion	30 May 2018
Sites	1 location across Sweden

Drugs / interventions tested

• Sentinel node procedure

Conditions studied

• Endometrial Neoplasms — all drugs for Endometrial Neoplasms →

Sponsor

Region Skane — full company profile →

Who can join

18 and older, female only, with Endometrial Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.