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Updated: Mar 9, 2026
Sentinel Lymph Node Mapping and Biopsy for Endometrial Cancer at Early Stage with Laparoscopy
Published on: August 19, 2021
One-step nucleic acid amplification versus ultra-staging to detect sentinel lymph node metastasis in endometrial
Nicolò Bizzarri1, Maria Consiglia Giuliano2, Giuseppe Parisi2
1Fondazione Policlinico Universitario A. Gemelli, IRCCS, Del Bambino e di Sanità Pubblica, Dipartimento di Scienze Della Salute Della Donna, UOC Ginecologia Oncologica, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy.
Background:
Sentinel lymph node (SLN) biopsy is the standard of care in apparent early-stage endometrial cancer. However, ultra-staging protocols have not been standardized, which may contribute to variability in the detection of SLN metastases. The one-step nucleic acid amplification (OSNA) method has been proposed as a rapid and standardized technique to diagnose SLN metastasis.
Primary Objective:
To compare the ability to detect SLN metastasis between OSNA and ultra-staging.
Study Hypothesis:
OSNA is non-inferior to ultra-staging in detecting lymph node metastases.
Trial Design:
This is a prospective, multi-center, randomized, non-inferiority trial.
Major Inclusion/Exclusion Criteria:
The trial includes patients with histologically confirmed endometrial cancer and apparent (pre-operative) uterine-confined tumor, who are undergoing an attempt at SLN mapping. Exclusion criteria are uterine sarcoma (except for carcinosarcomas), de-differentiated or un-differentiated histology, fertility-sparing management, neoadjuvant therapy, previous surgery to pelvic lymph nodes, and suspicious lymph nodes on pre-operative imaging.
Primary Endpoint:
Incidence of SLN metastasis in the OSNA group versus the ultra-staging group.
Sample Size:
Assuming a maximum allowable difference of -4% in the proportion of patients with detected lymph node metastases (node-positive proportion) to declare non-inferiority, a power of 80%, and a significance level of 2.5% (one side), a sample size of 1922 (961 per arm) is needed.
Estimated Dates For Completing Accrual And Presenting Results:
Four years of accrual, with estimated results to be presented in 2029.
Trial Registration:
The trial is registered at ClinicalTrials.gov (NCT06935305).
