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

Not Applicable

Completed

• Conditions: Endometrial Cancer
• Interventions: Procedure: Cervical injection; Procedure: Hysteroscopic injection

• Registration Number: NCT04302714
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2017-03-20
• Primary Completion: 2019-03-28
• Status Verified: 2020-02
• Study Completion: 2020-02-25
• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-10
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 165

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cervical injection	Cervical injection	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.
hysteroscopic injection	Hysteroscopic injection	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.

Primary Outcome Measures

Name	Time	Method
Detection rate	30 month	assessment of Detection rate in the para-aortic area

Secondary Outcome Measures

Name	Time	Method
Detection rate	30 month	Detection rate in the pelvic area
Operative time	30 month	Operative time to detect and remove sentinel node
Intraoperative complications	30 month	Intraoperative complications during the sentinel lymph node dissection
Postoperative complications	30 month	Postoperative complications graded per the Clavien-Dindo Classification system

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Nazionale Tumori; 🇮🇹 Milano, Italy