1. Novel single‐operator through‐the‐scope traction device for endoscopic submucosal dissection: Outcomes of a multicenter randomized pilot ex‐vivo study in trainees with limited endoscopic submucosal dissection experience (with video)
- Author
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Yang, Dennis, Aihara, Hiroyuki, Hasan, Muhammad K, Simsek, Cem, Khan, Hafiz, Brar, Tony S, Gorrepati, Venkata S, Forde, Justin J, Kadkhodayan, Kambiz, Arain, Mustafa A, and Draganov, Peter V
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,endoscopic resection ,endoscopic submucosal dissection ,traction ,trainees - Abstract
ObjectivesEndoscopic submucosal dissection is a technically demanding procedure. The pilot study aimed to prospectively evaluate the efficacy and safety of a novel single-operator through-the-scope dynamic traction device among trainees with limited endoscopic submucosal dissection (ESD) experience.MethodsRandomized, controlled, pilot study comparing traction-assisted ESD (T-ESD) versus conventional ESD (C-ESD) in an ex-vivo porcine stomach model. Trainees were randomized to group 1 (T-ESD followed by C-ESD) and group 2 (C-ESD followed by T-ESD). Lesions were created on the gravity-dependent area of the stomachs. The primary outcome was submucosal dissection speed. Secondary outcomes included differences in en-bloc resection, adverse events, and workload, assessed by the National Aeronautical and Space Administration Task Load Index (NASA-TLX).ResultsFive trainees performed two T-ESD and two C-ESD each, for a total of 20 procedures. Submucosal dissection speed was significantly faster in the T-ESD group compared to the C-ESD group (43.32 ± 22.61 vs. 24.19 ± 15.86 mm2/min; p = 0.042). En-bloc resection was achieved in 60% with T-ESD and 70% with C-ESD (p = 1.00). The muscle injury rate was higher in the C-ESD group (50% vs. 10%; p = 0.21) with 1 perforation reported with C-ESD and none with T-ESD. NASA-TLX physical demand was lower with T-ESD compared to C-ESD (4.5 ± 2.17 vs. 6.9 ± 2.50; p = 0.03).ConclusionT-ESD resulted in faster submucosal dissection and less physical demand when compared to C-ESD, as performed by trainees in an ex-vivo gravity-dependent model. Future studies are needed to assess its role in human ESD cases.
- Published
- 2023