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

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

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

Official Title
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Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer: a Multicenter Prospective Randomized Study

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Procedure: Hysteroscopic injection
* Procedure: Cervical injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cervical injection<br>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. | Procedure: Cervical injection<br>* Cervical injection<br>|
| Experimental: hysteroscopic injection<br>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. | Procedure: Hysteroscopic injection<br>* Hysteroscopic injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate | assessment of Detection rate in the para-aortic area | 30 month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical injection, Hysteroscopic injection