Feasibility of Detecting Fluorescent Marking Clip with Novel Fluorescence Detection System in Minimally Invasive Stomach and Esophageal Surgery

TL;DR

This study tests a new near-infrared fluorescence detection system to accurately locate fluorescent clips placed during minimally invasive stomach and esophageal cancer surgeries.

Contribution

The novel fluorescence detection system uses spectral analysis for higher sensitivity in detecting fluorescent clips during surgery.

Findings

The new system is expected to detect fluorescent clips with high accuracy by analyzing spectral characteristics.

The study will compare detection rates and times between the novel and existing fluorescence imaging systems.

Fluorescent clips may provide a reliable method for tumor localization in minimally invasive GI surgery.

Abstract

Background: Determining the optimal resection line for an organ that cannot be palpated is crucial, but challenging, in minimally invasive gastrointestinal (GI) surgery. Therefore, there is an urgent need to establish the most effective method for tumor localization. We hypothesize that our novel near-infrared (NIR) fluorescence detection system will enable the highly accurate detection of fluorescent clips marking GI cancer. Methods: Twenty-five patients with gastric cancer, esophagogastric junctional cancer, or esophageal cancer will be enrolled. NIR fluorescent clips will be placed endoscopically around the tumor on the day before surgery. Patients in whom clip dislodgement is confirmed by preoperative abdominal radiography will be excluded. The clips will be placed before the transection of the organ, and those on the surgical specimen will be observed after transection using both the novel NIR fluorescence detection system and an existing NIR fluorescence imaging system. The detection rate and time, the fluorescence intensity, surgical margins, and adverse events will be evaluated. This study has been registered in the Japan Registry of Clinical Trials, with the code jRCTs012240043. (Expected) Results: As the novel fluorescence detection system allows for higher-sensitivity detection by analyzing the spectral characteristics of fluorescence and measuring the peak values, we anticipate that this new system will detect the fluorescent clips with high accuracy. Conclusions: This study aims to establish a novel tumor-marking method using fluorescent clips and a new detection system that can be easily applied in various medical facilities.

Figures