Abstract
Introduction: Lack of effective devices to aid in tissue traction to facilitate endoscopic submucosal dissection (ESD) leads to prolonged dissection time. Clip and line (CL) method is commonly used to provide traction and improve visualization of the submucosa. A novel through the scope dynamic steerable grasping arm (SGA) has recently been available. We aim to prospectively study the efficacy of this new device with novice endoscopists in an ex vivo setting. Methods: This is a prospective single center randomized trial. In an ex-vivo porcine stomach model, two 25mm circular lesions were marked. Submucosal injection using a lifting agent and circumferential incision was performed. Novice endoscopists with no prior experience of ESD and with one to three years of experience of performing endoscopies were randomized to either SGA (study group) or CL method (control group) first. Each endoscopists performed ESD with both methods. Primary outcome was total dissection time in minutes. Adverse events of muscle injury, perforation, mucosal injury or tissue fragmentation were noted. Participants were asked to choose their preferred traction method for future ESDs. Subsequently, NASA task load index was used to grade subjective mental and physical work load. Results: Ten subjects participated in the study and five were randomized to SGA method first. The mean dissection time was significantly shorter when using SGA compared to clip and line method (5.07 ± 2.19 mins vs 20.07 ± 8.45 mins, P< 0.001) irrespective of order of randomization. Four instances of muscle injury and one perforation were noted with CL and none with SGA. NASA task load index scores across the domains of mental demand (7.9 ± 3.1 vs 15 ± 4 , P< 0.001), physical demand (6.4 ± 2.5 vs 12.9 ± 5.6, P=0.009), temporal demand (5.6 ± 3.3 vs 13.8 ± 4.3, P< 0.001), performance (3.9 ± 3.2 vs 9.2 ± 5.0, P=0.02), effort (8.4 ± 3.5 vs 16.3 ± 2.8, P< 0.001) and frustration (3.9 ± 2.3 vs 14.3 ± 5.1, P< 0.001) were significantly lower with SGA compared to CL. All participants preferred SGA over CL method. Conclusion: With novice endoscopists performing ESD, SGA leads to faster dissection time compared to CL for traction with a reduced mental and physical work load. There was a trend towards reduced adverse events with SGA. SGA is a promising tool to improve efficiency and learning curve of ESD (Table). Table 1. - Dissection times between two methods across the two randomized groups Randomization Number of subjects Dissection time in minutes using SGA (mean +/- SD) Dissection time in minutes using CL (mean +/- SD) P value SGA first 5 5.32 + 2.21 22.6 + 11.42 0.017 CL first 5 4.82 + 2.41 17.5 + 3.70 0.002 Total 10 5.07 + 2.19 20.07 + 8.45 < 0.001 SGA: Steerable grasping arm; CL: Clip and line.
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