- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04302714
Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer (SLN_EC)
March 10, 2020 updated by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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: a multicenter prospective randomized study
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer
Study Type
Interventional
Enrollment (Actual)
165
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Milano, Italy, 20133
- Fondazione IRCCS Istituto Nazionale Tumori
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
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Cervical injection
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Experimental: 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.
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Hysteroscopic injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection rate
Time Frame: 30 month
|
assessment of Detection rate in the para-aortic area
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30 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection rate
Time Frame: 30 month
|
Detection rate in the pelvic area
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30 month
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Operative time
Time Frame: 30 month
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Operative time to detect and remove sentinel node
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30 month
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Intraoperative complications
Time Frame: 30 month
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Intraoperative complications during the sentinel lymph node dissection
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30 month
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Postoperative complications
Time Frame: 30 month
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Postoperative complications graded per the Clavien-Dindo Classification system
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30 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Antonino Ditto, MD, Fonsazione IRCCS Istituto Nazionale Tumori Milano
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Solima E, Martinelli F, Ditto A, Maccauro M, Carcangiu M, Mariani L, Kusamura S, Fontanelli R, Grijuela B, Raspagliesi F. Diagnostic accuracy of sentinel node in endometrial cancer by using hysteroscopic injection of radiolabeled tracer. Gynecol Oncol. 2012 Sep;126(3):419-23. doi: 10.1016/j.ygyno.2012.05.025. Epub 2012 May 30.
- Martinelli F, Ditto A, Bogani G, Signorelli M, Chiappa V, Lorusso D, Haeusler E, Raspagliesi F. Laparoscopic Sentinel Node Mapping in Endometrial Cancer After Hysteroscopic Injection of Indocyanine Green. J Minim Invasive Gynecol. 2017 Jan 1;24(1):89-93. doi: 10.1016/j.jmig.2016.09.020. Epub 2016 Oct 8.
- Maccauro M, Lucignani G, Aliberti G, Villano C, Castellani MR, Solima E, Bombardieri E. Sentinel lymph node detection following the hysteroscopic peritumoural injection of 99mTc-labelled albumin nanocolloid in endometrial cancer. Eur J Nucl Med Mol Imaging. 2005 May;32(5):569-74. doi: 10.1007/s00259-004-1709-4. Epub 2004 Dec 30.
- Raspagliesi F, Ditto A, Kusamura S, Fontanelli R, Vecchione F, Maccauro M, Solima E. Hysteroscopic injection of tracers in sentinel node detection of endometrial cancer: a feasibility study. Am J Obstet Gynecol. 2004 Aug;191(2):435-9. doi: 10.1016/j.ajog.2004.03.008.
- Niikura H, Okamura C, Utsunomiya H, Yoshinaga K, Akahira J, Ito K, Yaegashi N. Sentinel lymph node detection in patients with endometrial cancer. Gynecol Oncol. 2004 Feb;92(2):669-74. doi: 10.1016/j.ygyno.2003.10.039.
- Gargiulo T, Giusti M, Bottero A, Leo L, Brokaj L, Armellino F, Palladin L. Sentinel Lymph Node (SLN) laparoscopic assessment early stage in endometrial cancer. Minerva Ginecol. 2003 Jun;55(3):259-62.
- Pelosi E, Arena V, Baudino B, Bello M, Giusti M, Gargiulo T, Palladin D, Bisi G. Pre-operative lymphatic mapping and intra-operative sentinel lymph node detection in early stage endometrial cancer. Nucl Med Commun. 2003 Sep;24(9):971-5. doi: 10.1097/00006231-200309000-00005.
- Pelosi E, Arena V, Baudino B, Bello M, Gargiulo T, Giusti M, Bottero A, Leo L, Armellino F, Palladin D, Bisi G. Preliminary study of sentinel node identification with 99mTc colloid and blue dye in patients with endometrial cancer. Tumori. 2002 May-Jun;88(3):S9-10. doi: 10.1177/030089160208800322.
- Ditto A, Martinelli F, Bogani G, Papadia A, Lorusso D, Raspagliesi F. Sentinel node mapping using hysteroscopic injection of indocyanine green and laparoscopic near-infrared fluorescence imaging in endometrial cancer staging. J Minim Invasive Gynecol. 2015 Jan;22(1):132-3. doi: 10.1016/j.jmig.2014.08.009. Epub 2014 Aug 15.
- Perrone AM, Casadio P, Formelli G, Levorato M, Ghi T, Costa S, Meriggiola MC, Pelusi G. Cervical and hysteroscopic injection for identification of sentinel lymph node in endometrial cancer. Gynecol Oncol. 2008 Oct;111(1):62-7. doi: 10.1016/j.ygyno.2008.05.032. Epub 2008 Jul 14.
- Cormier B, Rozenholc AT, Gotlieb W, Plante M, Giede C; Communities of Practice (CoP) Group of Society of Gynecologic Oncology of Canada (GOC). Sentinel lymph node procedure in endometrial cancer: A systematic review and proposal for standardization of future research. Gynecol Oncol. 2015 Aug;138(2):478-85. doi: 10.1016/j.ygyno.2015.05.039. Epub 2015 Jun 3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2017
Primary Completion (Actual)
March 28, 2019
Study Completion (Actual)
February 25, 2020
Study Registration Dates
First Submitted
February 26, 2020
First Submitted That Met QC Criteria
March 6, 2020
First Posted (Actual)
March 10, 2020
Study Record Updates
Last Update Posted (Actual)
March 12, 2020
Last Update Submitted That Met QC Criteria
March 10, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INT 09/17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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