Olympus reviewed the literature titled "risk factors for perforation during colorectal endoscopic submucosal dissection." endoscopic submucosal dissection (esd) achieves higher en bloc resection rates than endoscopic mucosal resection in early colorectal neoplasms.However, perforation occurs more frequently during esd.We aimed to identify the risk factors for perforation during colorectal esd.A total of 161 patients treated with colorectal esd at a tertiary center between january 2014 and december 2019 were enrolled in this retrospective study.Perforation was defined as a deep defect of the muscularis propria, with or without direct contact with connective tissue outside the colon.Clinical risk factors for perforation during esd, including age, sex, tumor morphology, tumor size, tumor location, procedure time, en bloc resection rate, histology, and submucosal fibrosis, were analyzed.The mean size of the esd specimens was 38.2 ± 24.6 mm.The overall en bloc resection rate was 98.1%.Perforations occurred during esd in 31 out of 161 patients (19.3%).All perforations were successfully treated with endoscopic closure using the hemoclips and nonsurgical management.Emergency surgery was not required in our patients.On multivariate analysis, severe submucosal fibrosis (odds ratio [or] 3.06; 95% confidence interval [ci] 1.23-7.59; p =.016) and location in the right colon (or 4.54; 95% ci 1.31-15.79; p =.017) were independent risk factors.Perforation during colorectal esd occurred in 31 patients (19.3%), but all patients had a good outcome without surgery.Submucosal fibrosis and its location are risk factors for perforation during esd.Type of adverse events/number of patients: perforation - 31 patients minor bleeding - number of patients not specified all perforations that occurred during colorectal esd were successfully managed with endoscopic closure without rescue surgery.Most cases showed minor bleeding, which were successfully managed with immediate hemostasis by hemoclipping and coagulation.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or 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 events cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.
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