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

April 28, 2021 updated by: Antonio Simone Laganà, Università degli Studi dell'Insubria

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Injection of Indocyanine green within the uterine cervix before to perform laparoscopic/robotic 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi dell'Insubria

Investigators

  • Study Chair: Antonio Simone Laganà, M.D., Ph.D., Università degli Studi dell'Insubria
  • Principal Investigator: Benito Chiofalo, M.D., Regina Elena National Cancer Institute, Rome, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2025

Primary Completion (Anticipated)

February 1, 2030

Study Completion (Anticipated)

February 1, 2035

Study Registration Dates

First Submitted

January 26, 2020

First Submitted That Met QC Criteria

January 26, 2020

First Posted (Actual)

January 29, 2020

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GREEN-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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