Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Bilateral node detection rates | target = 70% to 90% | Day 0 (during surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| sentinel nodes | number of sentinel nodes collected | Day 0 (during surgery) |
| Salvage operations in case of GS failure | Number of salvage operations |
Not provided
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
Not provided
Not provided
Not provided
Not provided
30 patients over 18 months total duration of the study 20 months
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre-François DUPRE, MD | Contact | +33 2 98 22 37 59 | pierre-françois.dupre@chu-brest.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Brest | Brest | 29609 | France |
|
All collected data that underlie results in a publication
Data will be available beginning 18 month and ending five years following the publication
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
Not provided
Not provided
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 0 (during surgery) |
| adverse events | Per and post operative adverse events according to Clavine Dindo Classification | Day 30 |
| factors for detection failure | Day 0 (during surgery) |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |