Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer (SLN_EC)

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status: Completed

Conditions: Endometrial Cancer

Treatments: Procedure: Cervical injection; Procedure: Hysteroscopic injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04302714

INT 09/17

Details and patient eligibility

About

Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer: a multicenter prospective randomized study

Full description

Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer

Enrollment: 165 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent from the patient;
• Histological diagnosis of endometrial cancer (including type I and II EC);
• Early stage (FIGO stage < 4);
• Age older than 18 years.

Exclusion criteria

• Preoperative diagnosis of extra-uterine disease;
• Preoperative suspicious of gross positive nodes;
• Execution of neoadjuvant chemotherapy;
• Contraindication to upfront general anesthesia and or mini-invasive surgery;
• Systemic infections ongoing;
• Pregnancy ongoing.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 2 patient groups

cervical injection

Active Comparator group

Description:

Fluorescent SLN Imaging With Indocyanine Green (ICG), using near-infrared fluorescence imaging, will be used as a dye for SLN mapping. Injections will be performed intraoperative. Concentration of ICG used is 1.25mg/mL, the 25mg dry powder bottle is mixed with 20 mL of sterile water in the operating room, and 4 mL is injected directly into the cervix. This solution was injected intracervically at 3 and 9 o'clock positions, both submucosally and deep into the cervical stroma. A spinal needle 18-gauce is used to inject the ICG. The 4 mL can be divided into 4 separate injections (1 mL each). The ICG should be injected slowly, at a rate of 5 to 10 seconds per quadrant.

Treatment:

Procedure: Cervical injection

hysteroscopic injection

Experimental group

Description:

hysteroscopy is performed using an operative hysteroscope. Uterine distension is obtained by means of saline solution. Usually, the fluid bag is placed 50 cm above the patient's plane so that the intracavitary pressure does not exceed 40 mm Hg. After visualization of uterine cavity a 22-gauce, 40-mm needle was introduced into the operative port and IGC is injected peritumorally. Concentration of ICG used is 1.25mg/mL, the 25mg dry powder bottle is mixed with 20 mL of sterile water in the operating room. The injection is performed subendometrially around the lesion, or, if the uterine cavity was totally involved by disease, at 3, 6, 9, and 12 o'clock . The depth of needle placement is modulated by visualizing endometrial elevation during injection.

Treatment:

Procedure: Hysteroscopic injection