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

NCT04246580 | Completed

• 1 other identifier: GREEN-1
• Study Type: observational
• Target: 230
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometrial Cancer; Cervical Cancer

Keywords

Indocyanine green; Pelvic lymphadenectomy

Outcome Measures

Primary Outcomes (1)

• Retrieved lymph nodes

  Number of retrieved lymph nodes after laparoscopic/robotic systematic pelvic lymphadenectomy

  At the moment of the surgery

Study Arms (2)

Indocyanine green

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

Procedure: Indocyanine green-guided systematic pelvic lymphadenectomy

Control

Women with endometrial and cervical cancer undergoing systematic pelvic lymphadenectomy by laparoscopy or robotic surgery without the use of indocyanine green tracer injection.

Interventions

Indocyanine green-guided systematic pelvic lymphadenectomy PROCEDURE

Injection of Indocyanine green within the uterine cervix before to perform laparoscopic/robotic systematic pelvic lymphadenectomy

Indocyanine green

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• Women affected by endometrial or cervical cancer
• Laparoscopic/robotic surgical approach with systematic pelvic lymphadenectomy.

You may not qualify if:

• Women undergoing open surgery (laparotomy) for the surgical management of endometrial or cervical cancer.

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Related Publications (1)

• 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.

  PMID: 36834170 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Cervical Diseases

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2020
• First Posted: January 29, 2020
• Study Start: January 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share