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

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 (126.2 vs 122.2 mmHg; P=0.02) and platelet count (221.1 vs 200.7 × 10^9/L; P=0.03) in the Y20 group. Intraoperative vessel sealing success was achieved in 100.00% (90/90) of the experimental group and 98.88% (88/89) of the control group (P=0.30). The between-group difference was 1.12% [95% confidence interval (CI): −3.15% to 6.21%]. The lower limit of the 95% CI (−3.15%) was greater than the non-inferiority margin of −10% (P<0.001). There were no statistically significant differences in intraoperative blood loss, postoperative drainage, or operative time (all P>0.05). Device-related adverse events occurred in 0/90 (0%) Y20 versus 1/89 (1.11%) GEN11CN patients. No serious device-related events, deaths, or postoperative hemorrhage occurred through 30 days.

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: