Sentinel Lymph Node Detection in Endometrial Cancer

NCT02690259CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Region Skane

Enrollment

257

Start Date

2014-06-01

Completion Date

2018-05-30

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Sentinel node procedure

Conditions

Endometrial Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Detection of sentinel nodes

The study measures the sensitivity of the described Sentinel node concept regarding the detection of Sentinel lymph nodes and detection of lymph node metastases

Time frame: up to 2 months

Detection of Sentinel nodes

The study measures the specificity of the described Sentinel node concept regarding the detection of Sentinel lymph nodes and detection of lymph node metastases

Time frame: up to 2 months

Detection of Setinel nodes

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

Time frame: up to 2 months

Secondary Outcomes

Recurrence rates

The study measures the recurrence rate after concluded treatment including the Sentinel node concept

Time frame: up to 24 months after inclusion

Lymphatic complications

Comparison of the incidence of lymphatic complications such as lymph cysts and lymph edema after Sentinel node biopsy and full pelvic and paraaortic lymphadenectomy.

Time frame: up to 24 months after inclusion

Locations

Department of Gynecology and Obstetrics, Lund, Sweden

Linked Papers

2021-09-09

Resection of the upper paracervical lymphovascular tissue should be an integral part of a pelvic sentinel lymph node algorithm in early stage cervical cancer

To investigate the prevalence of lymph nodes and lymph node metastases (LNMs) in the upper paracervical lymphovascular tissue (UPLT) in early stage cervical cancer. In this prospective study consecutive women with stage IA1-IB1 cervical cancer underwent a pelvic lymphadenectomy including identification of sentinel nodes (SLNs) as part of a nodal staging procedure in conjunction with a robotic radical hysterectomy (RRH) or robotic radical trachelectomy (RRT). Indocyanine green (ICG) was used as tracer. The UPLT was separately removed and defined as "SLN-parametrium" and, as all SLN tissue, subjected to ultrastaging and immunohistochemistry. Primary endpoint was prevalence of lymph nodes and metastatic lymph nodes in the UPLT. Secondary endpoints were complications associated with removal of the UPLT. One hundred and forty-five women were analysed. Nineteen (13.1%) had pelvic LNMs, all identified by at least one metastatic SLN. In 76 women (52.4%) at least one UPLT lymph node was identified. Metastatic UPLT lymph nodes were identified in six women of which in three women (2.1% of all women and 15.8% of node positive women) without lateral pelvic LNMs. Thirteen women had lateral pelvic SLN LNMs with either no (n = 5) or benign (n = 8) UPLT lymph nodes. No intraoperative complications occurred due to the removal of the UPLT. Removal of the UPLT should be an integral part of the SLN concept in early stage cervical cancer.

Sentinel Lymph Node Detection in Endometrial Cancer