Pelvic Sentinel Node Detection Using Indocyanine Green Learning Curve

Endometrial Cancer Clinical Trial

— ENDO-GREEN  

Official title:

Pelvic Sentinel Node According to SHREC-trial for the Application of the 2021 European Recommendations for Lymph Node Staging Strategy in Endometrial Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04958278
• Other study ID #: ENDO-GREEN ( 29BRC21.0078)
• Status: Not yet recruiting
• Start date: July 1, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: April 2021
• Source: University Hospital, Brest
• Contact: Pierre-François DUPRE, MD
• Phone: +33 2 98 22 37 59
• Email: pierre-françois.dupre[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

According to ESGO-ESTRO-ESMO guidelines, pelvic Sentinel lymph node detection is suitable for lymph node staging in endometrial carcinoma of the uteri. Nonetheless, a learning curve is mandatory to ensure the surgical quality of the sampling. The aim of the study is to assess the success of sentinel lymph node detection according to SHREC-Trial surgical strategy.

Description:

Introduction: According to ESGO-ESTRO-ESMO guidelines, pelvic Sentinel lymph node detection is suitable for lymph node staging in endometrial carcinoma of the uteri. The aim of the study is to assess the success of sentinel lymph node detection according to SHREC-Trial surgical strategy. Patients and Method: All patients presenting with early FIGO stage and low, intermediate, high intermediate or high risk endometrial carcinoma will be prospectively enrolled. Sentinel lymph node mapping will be performed using laparoscopic approach and cervical Indocyanine Green injection. Based on the surgical algorithm for detection of pelvic sentinel lymph node in endometrial cancer from Persson and coll., we designed a study with a target of 70% to 90% of bilateral detection rate . Thirty patients will be included over 18 months.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Letter of non objection Endometrial carcinoma Stage FIGO I-II whatever the histological subtype. ESGO-ESMO-ESTRO 2021 risk classification : low, intermediate, high intermediate, high Laparoscopic approach. Exclusion Criteria: Participation refusal Medical contraindication to laparoscopic approach. Stage FIGO > II Suspected Indocyanine Green allergy

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bilateral node detection rates	target = 70% to 90%	Day 0 (during surgery)
Secondary	sentinel nodes	number of sentinel nodes collected	Day 0 (during surgery)
Secondary	Salvage operations in case of GS failure	Number of salvage operations	Day 0 (during surgery)
Secondary	adverse events	Per and post operative adverse events according to Clavine Dindo Classification	Day 30
Secondary	factors for detection failure		Day 0 (during surgery)