S0953 Novel Axially Parallel Endoscopic Submucosal Dissection Knife vs Insulated Tip Endoscopic Submucosal Dissection Knife: Outcomes of a Randomized ex-vivo Pilot Study

Abstract

INTRODUCTION: Endoscopic Submucosal Dissection (ESD) is utilized for the treatment of large gastrointestinal tract lesions or lesions not amenable to standard endoscopic mucosal resection. Insulated tip (IT-ESD) knife is a commonly used knife for ESD. A recent axially paralleled ESD (AP-ESD) knife has shown promising results in tissue resection. The primary aim of this study was to compare the efficacy, safety, physical and mental workload of AP-ESD knife to IT-ESD knife in ex-vivo models. METHODS: This was a randomized-controlled, pilot study comparing IT-ESD to AP-ESD knife in ex-vivo porcine models. AP-ESD knife is a single use, electrocautery enhanced knife that allows for safe dissection and low risk of perforation given the parallel orientation of the knife to the mucosa [s]. A total of 18 participants divided into two groups (novices, n = 9 and experts n = 9) without prior experience with AP-ESD knife were randomized 1:1 into two groups (group 1: AP-ESD followed by IT-ESD; group 2: IT-ESD followed by AP-ESD). A standard template was used to create 2 × 2 cm gastric lesions. The primary outcome was complete en-bloc resection. Secondary outcomes included differences in procedure time, perforation rate, and National Aeronautical and Space Administration Task Load Index (NASA-TLX) to assess physical and mental workload. RESULTS: 18 participants each performed 2 tissue resections (1 AP-ESD and 1 IT-ESD), for a total of 36 procedures. Complete en-bloc resection was achieved in 33 models (resection rate 91.6%). No differences were observed in complete resection or perforation rate between IT-ESD and AP-ESD (88.2% vs 94.4%, P = 0.51 and 11.8 vs 11.1%, P = 0.95, respectively). Participants had a longer time with AP-ESD (1045 +/- 779 vs 783+/-532 seconds, P = 0.04) however there was no difference in demand using total NASA TLX (33 +/- 11 vs 39 +/- 9, P = 0.07). While experts (N = 9) had longer time with AP-ESD (895 +/- 649 seconds vs 595 +/- 383, P = 0.05), there was no difference in resection rate, perforation rate or NASA TLX demand. On the other hand, Novices (N = 9) showed no difference in resection rate, perforation rate or procedure time, however did have higher demand with AP-ESD (45 +/- 9 vs 37 +/- 11, P = 0.05). CONCLUSION: AP-ESD knife yielded similar rates of resection and perforation compared to a standard IT-ESD knife. Experts endoscopists required more time for dissection, likely due to an undefined learning curve with this new device and extensive familiarity with conventional knives.Figure 1.: Novel Axially Paralleled Endoscopic Submucosal Dissection (AP-ESD) Knife.