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

Sponsor
University Hospital, Brest (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04958278
Collaborator
(none)
30
1
16
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Anticipated Study Start Date :
    Jul 1, 2021
    Anticipated Primary Completion Date :
    Oct 31, 2022
    Anticipated Study Completion Date :
    Oct 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Bilateral node detection rates [Day 0 (during surgery)]

      target = 70% to 90%

    Secondary Outcome Measures

    1. sentinel nodes [Day 0 (during surgery)]

      number of sentinel nodes collected

    2. Salvage operations in case of GS failure [Day 0 (during surgery)]

      Number of salvage operations

    3. adverse events [Day 30]

      Per and post operative adverse events according to Clavine Dindo Classification

    4. factors for detection failure [Day 0 (during surgery)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest Brest France 29609

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT04958278
    Other Study ID Numbers:
    • ENDO-GREEN ( 29BRC21.0078)
    First Posted:
    Jul 12, 2021
    Last Update Posted:
    Jul 12, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Brest
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 12, 2021