Olympus received the literature titled "efficacy and safety of novel hemostatic gel in endoscopic sphincterotomy or endoscopic papillectomy: a multicenter, randomized controlled clinical trial." background: endoscopists often experience obstacles with traditional hemostasis using the side-viewing duodenoscope for bleeding after endoscopic sphincterotomy (est) or endoscopic papillectomy (ep).Aims: in this randomized controlled trial, we evaluated the efficacy and safety of a novel hemostatic gel for post-est or post-ep bleeding.Methods: a randomized trial was conducted from november 2020 to december 2021 at two tertiary centers in south korea.Patients who experienced bleeding immediately after est or ep were enrolled in the study, and primary hemostasis was achieved with either the novel hemostatic gel or epinephrine spray.Results: a total of 84 patients were enrolled in this study, and 41 patients were finally analyzed in each group.Hemostatic gel was significantly superior to epinephrine spray for successful primary hemostasis (100% vs.85.4%; p = 0.026).).In terms of delayed bleeding, no significant difference was observed between the hemostatic gel and epinephrine spray (2.4% vs.7.3%; p = 0.329).The mean procedural time was significantly higher for the hemostatic gel than epinephrine spray (3.23 ±1.94 vs.1.76 ±0.99 min; p < 0.001), and no differences were observed in the adverse events.Conclusions: the novel hemostatic gel is expected to achieve satisfactory results with easier hemostasis for immediate bleeding after est or ep.Adverse events suspected to be associated with the procedure were 14.6% in the epinephrine group and 7.3% in the cggel group, with no significant differences.There were three cases of abdominal pain and three cases of pancreatitis in the epinephrine group.Two patients suffering from fever and one case of pancreatitis were observed in the cggel group.All these cases were evaluated as mild to moderate severity aes, and all events improved with conservative management.Type of adverse events/number of patients: abdominal pain (3) fever (2) pancreatitis (4) this report is related to the following patient identifiers: (b)(6) (evis lucera duodenovideoscope / tjf-260v) (b)(6) (disposable electrosurgical snare / sd-210u-25) this medwatch is for (b)(6).
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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 event 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.This supplemental report includes additional information received from the author.B5 updated accordingly.Olympus will continue to monitor field performance for this device.
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