ABSTRACT
Objective:To evaluate the performance, efficacy and safety of a novel portable endoscopy system for upper gastrointestinal examination.Methods:A multicentered, open-label, randomized, non-inferiority controlled study was conducted in 3 clinical research centers from June 2019 to June 2020, and a total of 90 outpatients admitted to Department of Gastroenterology were randomly assigned to the trial group ( n=44) undergoing portable endoscopy and the control group ( n=46) undergoing Olympus endoscopy. The examination success rate, image quality, performance, overall operation satisfaction rate, biopsy success rate and adverse events of the two groups were compared. Results:The examination success rates of the trial group and the control group were 97.73% (43/44) and 100.00% (46/46) respectively with a difference of -2.27% (95% CI: -6.68%-2.13%), higher than the set non-inferiority margin of -10%. Rates of good and excellent image quality were 100% in both groups, and the difference of 0 was higher than the set non-inferiority margin of -10%. There was no significant difference in the rate of good and excellent performance of the operating system between the two groups [97.67% (42/43) VS 100.00% (46/46), P=0.483]. There was significant difference in the overall satisfactory rate of the operation between the two groups [86.05% (37/43) VS 100.00% (46/46), P=0.011]. A total of 9 cases underwent endoscopic biopsy, including 5 cases in the trial group and 4 cases in the control group. The biopsy channels in both groups were smooth and the biopsy were successfully completed. There was no significant difference in adverse event rate between the two groups [25.00% (11/44) VS 10.87%(5/46), χ2=3.07, P=0.080]. All adverse events disappeared in 48 hours, and no severe adverse events or device defect events occurred. Conclusion:The novel portable endoscopic system is comparable to Olympus endoscopic system in terms of the operating performance, the image quality and safety. Therefore, this system is safe and effective for upper gastrointestinal examination.
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Objective To evaluate the risk factors,treatment and follow-up of capsule retentions after capsule endoscopy examination.Methods A total of 1 100 capsule enteroscopic examinations,performed at our hospital from October 2006 to March 2013,were retrospectively studied.The positive findings of lesions, clinical indications of capsule endoscopy,treatment and follow-ups were recorded.Results The incidence of capsule retentions was 1.18%(n =13).The rates of capsule retentions in OGIB,suspected Crohn′s disease (CD),known CD,suspected tumors and chronic abdominal pain were 0.95%,4.0%,10.5%,7.1% and 0.3%,respectively.In 11 patients,the capsule was removed by means of double-balloon enteroscopy,the cap-sule was removed surgically in one patient,and spontaneous expulsion occurred in another patient after 1 year of treatment.Risk factors for capsule retention were known or suspected CD and suspected tumor(OR =11.44, P =0.02;OR =5.59,P =0.02),and suspected tumor was also a risk factor(OR =7.42,P =0.04).Conclu-sion Capsule endoscopy is a safe procedure with low risk of capsule retentions.Advantages and disadvantages of capsule endoscopy examinations should be considered carefully when high-risk patients are involved.
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ObjectiveTo evaluate the disinfective effect of a new peracetic acid solution for digestive endoscope.MethodsForty endoscopes were divided into experimental group and control group,10 gastroscopes and 10 enteroscopes in each group,the experimental group was disinfected with the new peracetic acid solution for 10 min,the control group was disinfected with 2％ glutaral for 10 min,the disinfection effect was compared.Subsequently,80 other endoscopes were divided into 4 groups,10 gastroscopes and 10 enteroscopes in each group,each group was disinfected for 2 min,3 min,4 min and 5 min,the disinfection efficiency was evaluated.ResultsThe disinfection rates of gastroscopes and enteroscopes in the control were 100％ (10/10)and 90％ (9/10)respectively.Bacteria were found in both endoscopes.In the experimental group,disinfection rates of both gastroscopes and enteroscopes were 100％ (10/10),and no bacterium was found,which was superior to the control.disinfection rates of gastroscopes of 3 min,4 min and 5 min were all 100％ (10/10),which were higher than that of 2 min group (30％) (P ＜0.05).Bacteria were found in 3 min group.Disinfection rates of 4 min and 5 min group were 100％ ( 10/10),which were higher than that of 3 min group (80％)(P ＜0.05).Bacteria were found in 4 min group,and 2 min group was not disinfected.ConclusionThe new peracetic acid solution is effective for clinic digestive endoscope disinfection,and is superior to 2％ glutaral.
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ObjectiveTo evaluate the accuracy of contrast-enhanced harmonic EUS (CEH-EUS) by using a second-generation contrast medium in differential diagnosis of pancreatic occupying lesions.MethodsPatients with suspected pancreatic neoplasms or chronic pancreatitis were enrolled and underwent CEH-EUS by using ultrasonic contrast medium Sonovue.Cytological and/or histological diagnoses were made by EUS-FNA and the final follow-up results.Characteristics of enhancement of the target areas,such as enhancement sequence,time features,pattern grade and venous elution degree were investigated.ResultsA total of 23 patients were enrolled,in which 13 were diagnosed with FNA as having pancreatic cancer,7 with chronic pancreatitis,2 with intraductal papillary mucinous neoplasms and 1 with microcystic serous cystadenoma.The accuracy of CEH-EUS was 95.65％,which was significantly higher than that of conventional EUS (78.2％).Enhancement of pancreatic cancer by CEH-EUS was later than or simultaneous with the nearby tissues,with heterogeneous low enhancement or fulfillment defect areas,and early subsidence without obvious peak.Enhancement of benign pancreatic diseases was simultaneous with the surrounding tissues,with homogenous fulfillment and simultaneous subsidence.ConclusionCEH-EUS is safe,convenient and accurate in diagnosis of pancreatic occupying lesions and can be used as an additional diagnostic method to EUSFNA.