Pelvic Sentinel Node Detection Using Indocyanine Green Learning Curve

• Conditions: Endometrial Cancer

• Registration Number: NCT04958278
• Lead Sponsor: University Hospital, Brest

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-07-01
• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-01
• Last Update Submitted: 2021-07-01
• Study First Posted: 2021-07-12
• Last Update Posted: 2021-07-12
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bilateral node detection rates	Day 0 (during surgery)	target = 70% to 90%

Secondary Outcome Measures

Name	Time	Method
Salvage operations in case of GS failure	Day 0 (during surgery)	Number of salvage operations
sentinel nodes	Day 0 (during surgery)	number of sentinel nodes collected
adverse events	Day 30	Per and post operative adverse events according to Clavine Dindo Classification
factors for detection failure	Day 0 (during surgery)

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France