Fluorescence-guided sleeve gastrectomy and gastric bypass: first-in-human trial using novel gastric calibration tube.

INTRODUCTION

Fluorescence-guided surgery employs a near-infrared emitting dye or light source to enhance intraoperative visualization. This study reports the first-in-human application of the Endolumik fluorescence-guided calibration tube (EGCT) during laparoscopic sleeve gastrectomy (SG) and gastric bypass (GB).

METHODS

Under IRB approval (NCT05486325), two surgeons performed 21 laparoscopic SG and 10 GB procedures using EGCT. Evacuation of gastric contents, gastric sleeve/pouch calibration, and leak testing were performed. Surgical and anesthesia providers completed surveys evaluating their EGCT experience.

RESULTS

No device-related adverse events occurred. EGCT was used by 10/5 unique surgical team members during SG/GB, respectively, and by 20/5 anesthesia providers. All surgical team members rated device experience as good or very good compared to the standard bougie. Visualization during gastric sleeve construction was rated as good or very good, and very good for gastric pouch construction. All surgical members reported confidence in the device enabling consistent gastric sleeve or pouch sizing. EGCT increased surgeon confidence level for device introduction during GB. Among anesthesia providers, 84% rated their experience during SG with the device as good or very good, including 89.5% of CRNAs. Additionally, 75%/90% of SG/GB clinicians believed the device reduced the likelihood of adverse events compared to standard devices. The average likelihood to recommend the EGCT was 9 out of 10 among surgeons.

CONCLUSION

EGCT improved visualization during gastric sleeve and pouch construction and increased confidence during device introduction for GB; surgeons would recommend the device to colleagues. Further research is needed to assess the impact on clinical outcomes.