ENDO-GREEN: Pelvic Sentinel Node Detection Using Indocyanine Green Learning Curve
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 |
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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
Outcome Measures
Primary Outcome Measures
- Bilateral node detection rates [Day 0 (during surgery)]
target = 70% to 90%
Secondary Outcome Measures
- 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)]
Eligibility Criteria
Criteria
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 | |
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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.- ENDO-GREEN ( 29BRC21.0078)