Evaluation of Indocyanine Green-guided Systematic Pelvic Lymphadenectomy in Endometrial and Cervical Cancer
NCT ID: NCT04246580
Last Updated: 2023-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
230 participants
OBSERVATIONAL
2014-01-31
2022-11-30
Brief Summary
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Since the modern imaging techniques are not yet able to accurately detect lymph nodes metastasis, pelvic systematic lymphadenectomy has still an important role and it still represents the gold standard in EC and CC. The sentinel lymph node (SLN) biopsy, which is a standard practice in breast cancer and melanoma, is often used in some early stage gynaecological cancers such as EC and CC.
Indocyanine green (ICG) is the most used tracer for the detection of SLN in gynaecological cancer, especially in laparoendoscopic setting. ICG allows a complete visualization of the lymphatic drainage and, for this reason, it may be used even in systematic pelvic lymphadenectomy to guide the surgeon during the procedure. Several studies have demonstrated an advantage of the ICG-guided lymphadenectomy in other types of cancers, showing a higher number of lymph nodes removed with this technique when compared to standard lymphadenectomy (without ICG).
To date, there is no published study about ICG-guided systematic pelvic lymphadenectomy in EC and CC. In this scenario, the aim of this study will be to compare systematic ICG-guided pelvic lymphadenectomy and standard lymphadenectomy in EC and CC.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Indocyanine green
Women with endometrial and cervical cancer undergoing indocyanine green-guided systematic pelvic lymphadenectomy by laparoscopy or robotic surgery
Indocyanine green-guided systematic pelvic lymphadenectomy
Injection of Indocyanine green within the uterine cervix before to perform laparoscopic/robotic systematic pelvic lymphadenectomy
Control
Women with endometrial and cervical cancer undergoing systematic pelvic lymphadenectomy by laparoscopy or robotic surgery without the use of indocyanine green tracer injection.
No interventions assigned to this group
Interventions
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Indocyanine green-guided systematic pelvic lymphadenectomy
Injection of Indocyanine green within the uterine cervix before to perform laparoscopic/robotic systematic pelvic lymphadenectomy
Eligibility Criteria
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Inclusion Criteria
* Laparoscopic/robotic surgical approach with systematic pelvic lymphadenectomy.
Exclusion Criteria
18 Years
70 Years
FEMALE
No
Sponsors
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Università degli Studi dell'Insubria
OTHER
Responsible Party
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Antonio Simone Laganà
Principal Investigator
Principal Investigators
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Benito Chiofalo, M.D.
Role: PRINCIPAL_INVESTIGATOR
Regina Elena National Cancer Institute, Rome, Italy
Antonio Simone Laganà, M.D., Ph.D.
Role: STUDY_CHAIR
Università degli Studi dell'Insubria
References
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Chiofalo B, Lagana AS, Ghezzi F, Certelli C, Casarin J, Bruno V, Sperduti I, Chiantera V, Peitsidis P, Vizza E. Beyond Sentinel Lymph Node: Outcomes of Indocyanine Green-Guided Pelvic Lymphadenectomy in Endometrial and Cervical Cancer. Int J Environ Res Public Health. 2023 Feb 16;20(4):3476. doi: 10.3390/ijerph20043476.
Other Identifiers
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GREEN-1
Identifier Type: -
Identifier Source: org_study_id
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