NCT04958278

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
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Endometrial Cancer

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2021-07-12
• Last updated: 2021-07-12

Locations

1 site across 1 country: France