SENTInel Node Mapping Versus Comprehensive Lymphadenectomy in P53-Mutated Endometrial Cancer: a Non-Inferiority Randomized Trial

NANot yet recruitingINTERVENTIONAL
Enrollment

374

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

October 31, 2031

Study Completion Date

October 31, 2031

Conditions
LymphadenectomyEndometrial CancerGene, P53Sentinel Lymph Node Biopsy (SLNB)
Interventions
PROCEDURE

Sentinel Lymph Node Mapping

The SLN mapping protocol will follow the EU guidelines and the consensus in competency assessment tool. Prior to SLN mapping, a full inspection of the pelvic areas with white light is performed to exclude the presence of extrauterine disease. The next surgical steps will be 1- identification of external iliac vessels, 2- identification of internal iliac artery, 3- dissection of the ureter, 4- development of paravesical space and 5- identification of obliterated umbilical ligament. The dissection technique must avoid disrupting lymphatic channels and isolate nodal tissue from the local anatomy. Indocyanine green (1.25mg/mL) will be injected in the cervix at the 3 and 9 o'clock positions, with 1mL superficial and 1mL deep, for a total of 4mL. All mapped SLNs must be completely excised, and any visually suspicious nodes should also be removed, regardless of the mapping results. If the SLN mapping appears to be unfeasible, a side-specific pelvic lymphadenectomy will be performed.

PROCEDURE

Comprehensive pelvic and para-aortic lymphadenectomy

"The resection of at least one lymph node in each of the 12 retroperitoneal regions is necessary:~A: upper para-aortic region B: lower para-aortic region C: interaorto-caval region D: paracaval region E: right and left iliaca communis region F: right and left iliaca externa region G: right and left fossa obturatoria region: defined by external and internal arteria iliaca, pelvic sidewall H: right and left iliaca interna region: lymph nodes adjacent to or medial of the internal iliacal artery"

All Listed Sponsors
lead

University Hospital, Strasbourg, France

OTHER