An interventional study of Hysteroscopic injection and Cervical injection in Endometrial Cancer, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. Completed at 1 site in Italy. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-03-12.
Sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Not applicable, Interventional, and Treatment
Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer: a multicenter prospective randomized study
Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's enrollment of 165 is above the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Fondazione IRCCS Istituto Nazionale dei Tumori, Milano is the lead sponsor of 169 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
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
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
Hysteroscopic injection
Cervical injection
Detection rate
assessment of Detection rate in the para-aortic area
Time frame: 30 month
Detection rate
Detection rate in the pelvic area
Time frame: 30 month
Operative time
Operative time to detect and remove sentinel node
Time frame: 30 month
Intraoperative complications
Intraoperative complications during the sentinel lymph node dissection
Time frame: 30 month
Postoperative complications
Postoperative complications graded per the Clavien-Dindo Classification system
Time frame: 30 month
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano