We conducted a multicenter retrospective comparative study, collecting data from January 2014 to November 2018 (Clinical Trial ID: NCT04246580; updated on 31 January 2023). All the consecutive patients with apparent early-stage EC and CC, without suspicious radiologic appearance of lymph nodal metastasis, who underwent laparoscopic or robotic systematic bilateral pelvic lymphadenectomy were included. The minimally invasive approach was chosen also in case of CC, since until November 2018 we had no strong evidence showing poorer survival outcomes with this type of surgery compared to the open surgical approach [21 (link)]. Indeed, until 2018, the laparoscopic approach was a potential alternative to laparotomic surgery because it was associated with a lower morbidity rate and similar oncologic outcomes [22 (link),23 (link),24 (link)]. Nevertheless, since 2018, much has changed in the surgical concepts of cervical and uterine cancer, including indications of minimally invasive surgery, sentinel node biopsy, and pelvic lymph node dissection, as further discussed in next sections.
Pre-operative work-up included medical history collection, physical and vaginal-pelvic examination, chest X-ray, ultrasound scans and pelvic magnetic resonance imagining (MRI) in all patients and positron emission tomography/computed tomography (PET/CT) scans in CC patients, following an algorithm previously described [25 (link)]. Patients who underwent incomplete pelvic lymphadenectomy (SLN biopsy, lymph nodes sampling) were excluded from the current analysis. All the surgical reports were analyzed to select patients who underwent ICG-guided systematic pelvic lymphadenectomy (ICG-LND) and patients who underwent standard systematic pelvic lymphadenectomy (conventional-LND). The choice to perform ICG-LND or conventional-LND was not influenced by any clinical parameter and was based on surgeon’s preference. All the histological reports were analyzed and data about the number of lymph nodes removed during surgery (primary outcome) were recorded. Furthermore, data about the type of tumor (EC or CC) and FIGO stage were collected.
The study was approved by the Institutional Review Boards of the referral center (“Regina Elena” National Cancer Institute of Rome—#CE RS1285/19(2297)) and of the participating centers. The design, analysis, interpretation of data, drafting, and revisions are in compliance with the Helsinki Declaration, the Committee on Publication Ethics guidelines, and the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement [26 (link)], validated by the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network. The study was not advertised, and no remuneration was offered to encourage patients to give consent for collection and analysis of their data. Each patient enrolled in this study was informed about the aims and procedures and provided their informed consent to allow data collection for research purposes.
Pre-operative work-up included medical history collection, physical and vaginal-pelvic examination, chest X-ray, ultrasound scans and pelvic magnetic resonance imagining (MRI) in all patients and positron emission tomography/computed tomography (PET/CT) scans in CC patients, following an algorithm previously described [25 (link)]. Patients who underwent incomplete pelvic lymphadenectomy (SLN biopsy, lymph nodes sampling) were excluded from the current analysis. All the surgical reports were analyzed to select patients who underwent ICG-guided systematic pelvic lymphadenectomy (ICG-LND) and patients who underwent standard systematic pelvic lymphadenectomy (conventional-LND). The choice to perform ICG-LND or conventional-LND was not influenced by any clinical parameter and was based on surgeon’s preference. All the histological reports were analyzed and data about the number of lymph nodes removed during surgery (primary outcome) were recorded. Furthermore, data about the type of tumor (EC or CC) and FIGO stage were collected.
The study was approved by the Institutional Review Boards of the referral center (“Regina Elena” National Cancer Institute of Rome—#CE RS1285/19(2297)) and of the participating centers. The design, analysis, interpretation of data, drafting, and revisions are in compliance with the Helsinki Declaration, the Committee on Publication Ethics guidelines, and the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement [26 (link)], validated by the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network. The study was not advertised, and no remuneration was offered to encourage patients to give consent for collection and analysis of their data. Each patient enrolled in this study was informed about the aims and procedures and provided their informed consent to allow data collection for research purposes.
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