Olympus reviewed the following literature: "endoscopic full-thickness resection versus endoscopic submucosal dissection in the treatment of colonic neoplastic lesions = 30 mm¿a single-center experience." literature summary: the purpose of the analysis was to evaluate efficacy and safety of full-thickness resection (ftr) in the treatment of colorectal lesions = 30 mm by comparing prospectively followed ftr cohort to retrospective submucosal dissection (esd) cohort in the setting of single tertiary endoscopy center.Primary outcomes were technical success rate, r0 resection and curative resection rate, and complication rate.A total of 52 patients in ftr and 50 patients in esd group were treated between 2015 and 2018.Technical success rate was significantly higher in ftr group (92 vs.74%, p = 0.01) as well as r0 resection rate (85 vs.62%, p = 0.01) and curative resection rate (75 vs.56%, p = 0.01).Complications occurred more frequently in esd group (40 vs.13%, p = 0.002), mainly due to high incidence of electrocoagulation syndrome (24 vs.0%).Total procedure time was substantially shorter in ftr group (26.4 ± 11.0 min vs.Estimated 90¿240 min).Local residual neoplastic lesions were detected numerically more often in ftr group (12 vs.5%, p = 0.12).No patient died during follow-up.Compared to esd, ftr proved significantly higher technical success rate, higher r0 and curative resection rate, and shorter procedure time.In the ftr group, there were significantly less complications but higher incidence of local residual neoplasia.Further research including randomized trials is needed to compare both resection techniques.Perforation occurred in 1 case in the ftr and in 4 cases in the esd group.In both groups, there were 4 cases of delayed bleeding.In esd group, there were 20 cases of electrocoagulation syndrome while none in ftr group.Two cases of acute appendicitis following ftr of periappendicular lesions were treated conservatively.No patient died during this study and follow-up.Type of adverse events/number of patients: ftr group: perforation - 1 patient.Delayed bleeding - 4 patients.Acute appendicitis - 2 patients.Esd group: perforation - 4 patients.Delayed bleeding - 4 patients.Coagulation syndrome - 12 patients.This article includes 8 reports: (b)(6) : kd-650u - esd only group adverse events.(b)(6) : kd-655u - esd only group adverse events.(b)(6) : fd-411ur - esd only group adverse events.(b)(6) : hx-110ur - esd only group adverse events.(b)(6) : hx-201yr-135 - esd only group adverse events.(b)(6) : d-201-14304 - esd only group adverse events.(b)(6) : (b)(4) - for all adverse events.(b)(6) : (b)(4) - we selected (b)(4) to represent the following olympus models used in the study: pcf-h190dl or pcf-hq190tl and is for all adverse events.This report is 1 of 8 for: (b)(6) : kd-650u - esd only group adverse events.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.New information was added to the following fields: h6, h10.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.
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