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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indocyanine green | Women with endometrial and cervical cancer undergoing indocyanine green-guided systematic pelvic lymphadenectomy by laparoscopy or robotic surgery |
| |
| Control | Women with endometrial and cervical cancer undergoing systematic pelvic lymphadenectomy by laparoscopy or robotic surgery without the use of indocyanine green tracer injection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine green-guided systematic pelvic lymphadenectomy | Procedure | Injection of Indocyanine green within the uterine cervix before to perform laparoscopic/robotic systematic pelvic lymphadenectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Retrieved lymph nodes | Number of retrieved lymph nodes after laparoscopic/robotic systematic pelvic lymphadenectomy | At the moment of the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Women affected by endometrial or cervical cancer undergoing laparoscopic/robotic systematic pelvic lymphadenectomy (with or without previous injection of indocyanine green tracer within the uterine cervix).
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| Name | Affiliation | Role |
|---|---|---|
| Benito Chiofalo, M.D. | Regina Elena National Cancer Institute, Rome, Italy | Principal Investigator |
| Antonio Simone Laganà , M.D., Ph.D. | Università degli Studi dell'Insubria | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36834170 | Derived | 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. |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002577 | Uterine Cervical Diseases |