• Kerrie A Sullivan, Forough Farrokhyar, Grigorios I Leontiadis, Yogita S Patel, Isabella F Churchill, Danielle A Hylton, Feng Xie, SeelyAndrew J EAJEDivision of Thoracic Surgery, University of Ottawa, Ottawa, Ontario, Canada., Jonathan Spicer, Biniam Kidane, Simon R Turner, Kazuhiro Yasufuku, and Waël C Hanna.
• Division of Thoracic Surgery, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence & Impact, McMaster University, Hamilton, Ontario, Canada.
• J. Thorac. Cardiovasc. Surg. 2022 Jul 1; 164 (1): 254-261.e1.

ObjectiveTriple normal lymph nodes, appearing benign on computed tomography, positron emission tomography, and endobronchial ultrasound, have less than a 6% probability of malignancy. We hypothesized that targeted sampling (TS), which omits biopsy of triple normal lymph nodes during endobronchial ultrasound, is not an inferior staging strategy to systematic sampling (SS) of all lymph nodes.MethodsA prospective randomized feasibility trial was conducted to decide on the progression to a pan-Canadian trial comparing TS with SS. Patients with cN0-N1 non-small cell lung cancer undergoing endobronchial ultrasound were randomized to TS or SS. Lymph nodes in the TS arm crossed over to receive SS. Progression criteria included recruitment rate (70% minimum), procedure length (no significant increase for TS), and incidence of missed nodal metastasis (<6%). Mann-Whitney U test and McNemar's test on paired proportions were used for statistical comparisons.ResultsThe progression criterion of 70% recruitment rate was achieved early, triggering a planned early stoppage of the trial. Nineteen patients were allocated to each arm. The median procedure length for TS was significantly shorter than SS (3.07 vs 19.07 minutes; P < .001). After crossover analysis, 5.45% (95% confidence interval, 1.87-14.85) of lymph nodes in the TS arm were upstaged from N0 to N2, but this incidence of missed nodal metastasis was below the 6% threshold. During surgical resection, the nodal upstaging incidence from N0 to N2 was 0% for 15 lymph nodes in each arm.ConclusionsProgression criteria to a pan-Canadian, noninferiority crossover trial comparing TS with SS have been met, and such a trial is warranted.Copyright © 2021 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

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