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Pelvic Sentinel Node Detection Using Indocyanine Green Learning Curve (ENDO-GREEN)

R

Regional University Hospital Center (CHRU)

Status

Unknown

Conditions

Endometrial Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT04958278
ENDO-GREEN ( 29BRC21.0078)

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Pierre-François DUPRE, MD

Data sourced from clinicaltrials.gov

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