Sentinel node surgery trial#

Of published studies that have evaluated SLNB predominantly in this patient population, most were retrospective and performed at a single center, 10 - 12 did not perform PALND, 10 - 12 or used technetium Tc 99m or blue dye rather than more contemporary tracers.

Sentinel node surgery trial#

Only 13% of patients in the Sentinel Node and Endometrial Cancer (SENTI-ENDO) trial, 7 28% in the Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging (FIRES) trial, 8 and 49% in the Pelvic Sentinel Lymph Node Detection in High-Risk Endometrial Cancer (SHREC) trial 9 had high-grade histologic subtypes. 4 - 6Īlthough SLNB has gained acceptance in the context of low-grade EC, its role in high-grade EC remains unclear. 4, 5 Theoretically, SLNB should reflect the status of the entire nodal basin and provide the pathologic information required to guide decisions on adjuvant therapy while avoiding the heightened risks of intraoperative injury, chronic lymphedema, and other complications associated with complete lymphadenectomy. Sentinel lymph node biopsy (SLNB), or resection of only the first nodes receiving lymphatic drainage from the tumor site, has therefore been proposed as a less invasive strategy for nodal assessment. 1 Nodal metastases are traditionally identified on pelvic lymphadenectomy (PLND) and para-aortic lymphadenectomy (PALND), but 2 randomized clinical trials 2, 3 have suggested that lymph node resection independent of the effect of adjuvant therapy does not improve survival in patients with EC. The findings suggest that SLNB is a viable option for the surgical staging of EC.Įndometrial cancer (EC) that has metastasized to surrounding lymph nodes is associated with a poor prognosis and requires administration of adjuvant therapy. Seven of 27 patients with node-positive cancer (26%) were identified outside traditional PLND boundaries or required immunohistochemistry for diagnosis.Ĭonclusions and Relevance In this prospective cohort study, SLNB had acceptable diagnostic accuracy for patients with high-grade EC at increased risk of nodal metastases and improved the detection of node-positive cases compared with lymphadenectomy. Only 1 patient (0.6%) was misclassified by the SLNB algorithm. Of 27 patients (17%) with nodal metastases, 26 patients were correctly identified by the SLNB algorithm, yielding a sensitivity of 96% (95% CI, 81%-100%), a false-negative rate of 4% (95% CI, 0%-19%), and a negative predictive value of 99% (95% CI, 96%-100%). All patients underwent SLNB and PLND, and 101 patients (80%) with high-grade EC also underwent PALND. Results The study enrolled 156 patients (median age, 65.5 years range, 40-86 years median body mass index, 27.5 range, 17.6-49.3), including 126 with high-grade EC. Secondary outcomes were additional measures of diagnostic accuracy, sentinel lymph node detection rates, and adverse events. Main Outcomes and Measures The primary outcome was sensitivity of the SLNB algorithm. Patients with grade 2 endometrioid EC underwent pelvic lymphadenectomy (PLND) alone, and patients with high-grade EC underwent PLND and para-aortic lymphadenectomy (PALND). The study included patients with clinical stage I grade 2 endometrioid or high-grade EC scheduled to undergo laparoscopic or robotic hysterectomy with an intent to complete staging at 3 designated cancer centers in Toronto, Ontario, Canada.Įxposures All patients underwent SLNB followed by lymphadenectomy as the reference standard. Objective To examine the diagnostic accuracy of, performance characteristics of, and morbidity associated with SLNB using indocyanine green in patients with intermediate- and high-grade EC.ĭesign, Setting, and Participants In this prospective, multicenter cohort study (Sentinel Lymph Node Biopsy vs Lymphadenectomy for Intermediate- and High-Grade Endometrial Cancer Staging study), accrual occurred from July 1, 2015, to June 30, 2019, with early stoppage because of prespecified accuracy criteria. Importance Whether sentinel lymph node biopsy (SLNB) can replace lymphadenectomy for surgical staging in patients with high-grade endometrial cancer (EC) is unclear. Shared Decision Making and Communication.Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.Clinical Implications of Basic Neuroscience.Challenges in Clinical Electrocardiography.