Pelvic Sentinel Node Detection Using Indocyanine Green Learning Curve

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04958278

Acronym

ENDO-GREEN

Enrollment

Registered

2021-07-12

Start date

2021-07-01

Completion date

2022-10-31

Last updated

2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Keywords

endometrial cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Bilateral node detection rates	Day 0 (during surgery)	target = 70% to 90%

Secondary

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

Countries

France

Contacts

Primary ContactPierre-François DUPRE, MD

pierre-françois.dupre@chu-brest.fr+33 2 98 22 37 59

Outcome results