ArticleJournal of thoracic disease2026
Comparison of Y20 with GEN11CN (Harmonic HD 1000i) ultrasonic energy device for sealing 5-7 mm pulmonary vessels in thoracoscopic surgery: a multicenter, randomized, assessor- and statistician-blinded, noninferiority trial.
Article in Journal of thoracic disease, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Reliable sealing of 5-7 mm pulmonary vessels remains a persistent challenge in thoracoscopic surgery. Endostaplers are difficult to maneuver within the narrow interlobar fissure, and vascular clips are prone to slippage that can obscure the operative field. Ultrasonic energy devices offer an alternative for vessels of this caliber, but direct clinical comparisons between different device platforms are lacking. This study aimed to compare the success rate of sealing 5-7 mm blood vessels between a novel device (Y20) and the widely used GEN11CN (Harmonic HD 1000i). Methods: This was a multicenter, randomized, assessor- and statistician-blinded non-inferiority study. We enrolled patients aged 18-80 years scheduled for thoracoscopic anatomic segmentectomy or lobectomy who had at least one 5-7 mm vessel requiring sealing on computed tomography (CT) images, and randomly assigned them 1:1 to Y20 group or GEN11CN group. Patients with coagulopathy, severe thrombocytopenia, or recent active bleeding were excluded. Randomisation was stratified by centre using a central, computer-generated sequence held by an independent statistician. Device branding was masked with opaque covers so that the outcome evaluator remained blinded. The primary endpoint was the intraoperative vessel sealing success rate, defined as the absence of stump bleeding within a 10-minute observation window, with a prespecified non-inferiority margin of -10%. Secondary endpoints included intraoperative blood loss, operative time, postoperative drainage volume, and complications. Safety outcomes included laboratory parameters, vital signs, device-related sealing failures, and device-attributable complications. Results: Baseline characteristics were comparable except for higher systolic blood pressure (BP; 126.16 Conclusions: Y20 was noninferior to GEN11CN for intraoperative sealing of 5-7 mm pulmonary vessels and showed a comparable safety profile, supporting Y20 as a clinically acceptable alternative for this specific indication. These findings should not be generalized to vessels >7 mm or to settings without immediate rescue capability. Trial Registration: Chinese Clinical Trial Registry (ChiCTR2400088694; https://www.chictr.org.cn/showproj.html?proj=223068).
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