Indocyanine Green Versus Blue Dye for Detection of Sentinel Lymph Node In Endometrial Cancer

NCT02564276CompletedPHASE3INTERVENTIONAL

Summary

To determine the difference in the proportion of hemipelves with successful detection of Sentinel Lymph Node according to the dye used (indocyanine green with near-infrared imaging vs blue dye) in women with endometrial cancer.

Key Facts

Lead Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrollment

132

Start Date

2016-02-01

Completion Date

2017-04-01

Study Type

INTERVENTIONAL

Official Title

Indocyanine Green Versus Blue Dye for Detection of Sentinel Lymph Node In Endometrial Cancer

Interventions

Sentinel lymph node biopsy

Conditions

Endometrial Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* all patients with endometrial carcinoma proven by endometrial biopsy or curettage AND
* preoperative FIGO (International Federation of Gynecology and Obstetrics) stage I AND
* intended for staging via laparoscopic or robotic surgery AND
* Patients must be older than 18 year-old, able to read French or English.

Exclusion Criteria:

* preoperative FIGO stages II to IV
* previous pelvic or paraaortic lymphadenectomy or radiotherapy
* surgery that could change the uterine lymphatic drainage (myomectomy)
* iodine allergy
* pregnancy.

Outcome Measures

Primary Outcomes

the difference in the proportion of hemipelves with successful detection of SLN according to the dye used

Time frame: at time of surgery

Locations

Centre Hospitalier Universitaire Montréal Hôpital Saint Luc, Montreal, Canada

Linked Diseases

Endometrial Neoplasms

Endometrial Neoplasms — a type of gynecological cancer.

Indocyanine Green Versus Blue Dye for Detection of Sentinel Lymph Node In Endometrial Cancer