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

Completed

• Conditions: Endometrial Cancer; Cervical Cancer
• Interventions: Procedure: Indocyanine green-guided systematic pelvic lymphadenectomy

• Registration Number: NCT04246580
• Lead Sponsor: Università degli Studi dell'Insubria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2018-11
• Study First Submitted: 2020-01-26
• Study First Submitted QC: 2020-01-26
• Study First Posted: 2020-01-29
• Study Completion: 2022-11
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-29
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 230

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Indocyanine green	Indocyanine green-guided systematic pelvic lymphadenectomy	Women with endometrial and cervical cancer undergoing indocyanine green-guided systematic pelvic lymphadenectomy by laparoscopy or robotic surgery

Primary Outcome Measures

Name	Time	Method
Retrieved lymph nodes	At the moment of the surgery	Number of retrieved lymph nodes after laparoscopic/robotic systematic pelvic lymphadenectomy