Brief Title
Evaluation of Indocyanine Green-guided Systematic Pelvic Lymphadenectomy in Endometrial and Cervical Cancer
Official Title
Evaluation of Indocyanine Green-guided Systematic Pelvic Lymphadenectomy in Endometrial and Cervical Cancer
Brief Summary
The lymph nodes involvement is one of the most important prognostic factors in endometrial
(EC) and cervical cancer (CC). Indeed, the lymph node involvement in cancer patients modifies
the International Federation of Gynecology and Obstetrics (FIGO) stage and plays a pivotal
role in the choice of the adjuvant therapy.
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.
Study Type
Observational
Primary Outcome
Retrieved lymph nodes
Condition
Endometrial Cancer
Intervention
Indocyanine green-guided systematic pelvic lymphadenectomy
Study Arms / Comparison Groups
Indocyanine green
Description: Women with endometrial and cervical cancer undergoing indocyanine green-guided systematic pelvic lymphadenectomy by laparoscopy or robotic surgery
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
100
Start Date
February 2025
Completion Date
February 2035
Primary Completion Date
February 2030
Eligibility Criteria
Inclusion Criteria:
- Women affected by endometrial or cervical cancer
- Laparoscopic/robotic surgical approach with systematic pelvic lymphadenectomy.
Exclusion Criteria:
- Women undergoing open surgery (laparotomy) for the surgical management of endometrial
or cervical cancer.
Gender
Female
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Benito Chiofalo, M.D., +393296279579, [email protected]
Administrative Informations
NCT ID
NCT04246580
Organization ID
GREEN-1
Responsible Party
Principal Investigator
Study Sponsor
Università degli Studi dell'Insubria
Study Sponsor
Benito Chiofalo, M.D., Principal Investigator, Regina Elena National Cancer Institute, Rome, Italy
Verification Date
April 2021