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Endoscopic ultrasound-guided puncture suture device versus metal clip for gastric defect closure after endoscopic full-thickness resection: A randomized, comparative, porcine study.
Endoscopic Ultrasound 2016 July
OBJECTIVE: The secure closure of the wall defect is a critical stage of endoscopic full-thickness resection (EFTR). The aim of this study was to compare the closure of post-EFTR defects using an endoscopic ultrasound-guided puncture suture device (PSD) with the metal clip (MC) technique in a randomized, comparative, porcine study.
METHODS: We performed a randomized comparative survival study that included 18 pigs. The circular EFTR defects with a diameter of approximately 20 mm were closed with either a PSD or MC. Serum levels of interleukin-6 (IL-6) were determined preoperatively and on a postoperative day (POD) 1, 3, and 7. Three animals from each group were sacrificed at the end of the 7 th , 14 th , and 30 th POD. Tissue samples retrieved from the closure sites were examined macroscopically and microscopically.
RESULTS: Resection and closure were performed in 18 pigs (100%) without major perioperative complications. The mean closure time was significantly longer in the MC group than in the PSD group (25.00 ± 3.16 min vs. 1.56 ± 0.39 min; P < 0.05). Preoperative and POD 7 serum levels of IL-6 did not differ between the two groups. However, on POD 1, the IL-6 levels were observed to be significantly greater in the MC group than in the PSD group (P < 0.005). No significant differences between the PSD and MC groups were observed at necropsy.
CONCLUSION: In this in vivo porcine model, PSD is a feasible device that achieves post-EFTR defect closure with a much shorter closure time and with less immunological responses than the MC technique.
METHODS: We performed a randomized comparative survival study that included 18 pigs. The circular EFTR defects with a diameter of approximately 20 mm were closed with either a PSD or MC. Serum levels of interleukin-6 (IL-6) were determined preoperatively and on a postoperative day (POD) 1, 3, and 7. Three animals from each group were sacrificed at the end of the 7 th , 14 th , and 30 th POD. Tissue samples retrieved from the closure sites were examined macroscopically and microscopically.
RESULTS: Resection and closure were performed in 18 pigs (100%) without major perioperative complications. The mean closure time was significantly longer in the MC group than in the PSD group (25.00 ± 3.16 min vs. 1.56 ± 0.39 min; P < 0.05). Preoperative and POD 7 serum levels of IL-6 did not differ between the two groups. However, on POD 1, the IL-6 levels were observed to be significantly greater in the MC group than in the PSD group (P < 0.005). No significant differences between the PSD and MC groups were observed at necropsy.
CONCLUSION: In this in vivo porcine model, PSD is a feasible device that achieves post-EFTR defect closure with a much shorter closure time and with less immunological responses than the MC technique.
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