Evaluation of the utility of slow mode for pulmonary vessel resection using a surgical stapler in anatomical pulmonary resection: a prospective randomized controlled trial protocol.

BACKGROUND: Intraoperative bleeding from the pulmonary vessel stumps is a well-known complication of anatomical lung resection performed with surgical staplers. While advancements in stapling devices have improved safety, staple line bleeding (SLB) remains a serious concern as it can prolong operative time and increase complications risk. The SigniaTM stapling system features both adaptive firing technology plus mode (AFTM) and manual slow mode (MSM), allowing for adjustable staple firing speed. A retrospective study has suggested that MSM could minimize SLB risk; however, these findings lack confirmation from prospective studies. This study is aimed to investigate the utility of MSM for SLB prospectively.

METHODS: A total of 140 patients will be randomized into two groups. One group will undergo pulmonary vessel resection using AFTM and the other using MSM. The primary endpoint is intraoperative observation of SLB on pulmonary vessel stumps. Data analysis is scheduled for the period from 2025 to 2027.

DISCUSSION: This trial investigates whether MSM lowers the risk of SLB from pulmonary vessels and reduce the need for additional hemostatic procedures. If a slower firing speed is proven to minimize intraoperative SLB, selecting MSM could significantly improve the safety and efficiency of thoracic surgery. This could reduce complications, decrease the need for additional hemostatic interventions, and lower overall medical resource consumption.

TRIAL REGISTRATION: This trial was registered with the Japan Registry of Clinical Trials (https://jrct.mhlw.go.jp/re/reports/detail/91923).