Evaluation of Indocyanine Green-guided Systematic Pelvic Lymphadenectomy in Endometrial and Cervical Cancer

Overview

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

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: February 2021

Interventions

  • Procedure: Indocyanine green-guided systematic pelvic lymphadenectomy
    • Injection of Indocyanine green within the uterine cervix before to perform laparoscopic/robotic systematic pelvic lymphadenectomy

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Retrieved lymph nodes
    • Time Frame: At the moment of the surgery
    • Number of retrieved lymph nodes after laparoscopic/robotic systematic pelvic lymphadenectomy

Participating in This Clinical Trial

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 Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Università degli Studi dell’Insubria
  • Provider of Information About this Clinical Study
    • Principal Investigator: Antonio Simone Laganà, Principal Investigator – Università degli Studi dell’Insubria
  • Overall Official(s)
    • Benito Chiofalo, M.D., Principal Investigator, Regina Elena National Cancer Institute, Rome, Italy
    • Antonio Simone Laganà, M.D., Ph.D., Study Chair, Università degli Studi dell’Insubria
  • Overall Contact(s)
    • Antonio Simone Laganà, M.D., Ph.D., +393296279579, antoniosimone.lagana@uninsubria.it

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