Abstract
BACKGROUND: Previous studies have demonstrated that ultrasonic energy devices are safe and effective for sealing blood vessels in thoracoscopic surgery. However, no randomized controlled trials have been conducted to evaluate the safety and efficacy of using ultrasonic energy devices to seal blood vessels measuring 5-7 mm. This study aimed to compare the success rate of sealing 5-7 mm blood vessels between the SOUND REACH SR7 Shears (SRB) and the HARMONIC ACE +7 Shears with Advanced Hemostasis (ACE+7). METHODS: In this multicenter, noninferiority, randomized controlled trial, patients at four hospitals in China scheduled for thoracoscopic surgery with at least one blood vessel requiring sealing, as indicated by preoperative computed tomography (CT) images, were randomly assigned in a 1:1 ratio to either the SRB group or the ACE+7 group. The primary endpoint was the success rate of sealing target blood vessels. RESULTS: A total of 144 patients were enrolled between August and December 2023, and 133 patients were included in the full analysis set (FAS): 67 (50.4%) in the SRB group and 66 (49.6%) in the ACE+7 group. The SRB group included 37 lobectomies and 30 segmentectomies, while the ACE+7 group included 34 lobectomies, 30 segmentectomies, and two esophagectomies. A total of 67 blood vessels (62 arteries and five veins) were sealed in the SRB group, and 66 blood vessels (61 arteries and five veins) were sealed in the ACE+7 group. The success rate of sealing was 100% in both groups with an absolute difference of 0% (95% confidence interval: -5.5% to 5.4%) that did not cross the prespecified noninferiority margin of -10%. CONCLUSIONS: SRB demonstrated a non-inferior success rate for sealing 5-7 mm blood vessels in thoracoscopic surgery. SRB could be considered an alternative to ACE+7 for sealing 5-7 mm blood vessels in thoracoscopic surgery. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov (NCT06002737).