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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 operating performance, effectiveness and safety of a new portable endoscopic system for upper gastrointestinal endoscopy in an animal model.Methods:A parallel control, non-inferiority study was designed. Ten healthy Bana pigs were selected as the study subjects, and underwent upper gastrointestinal endoscopy using portable endoscope followed by Olympus GIF-Q260 endoscope. The instrument quality, image quality and safety of the new system were evaluated by means of quantitative scores.Results:The time for deployment and installing of the new portable endoscopic system during single operation was 110.24±8.93 s and 91.33±11.59 s, respectively, and the time for the endoscope with disposable protective cover was 233.48±17.06 s. The time of attracting 400 mL normal saline of the portable endoscope and Olympus endoscope was 56.44±5.18 s and 33.71±3.56 s, respectively. The water vapor attraction performance of the portable endoscope was not as good as the Olympus endoscope, but still met the technical requirements of medical devices (attraction capacity >400 mL/min). While in terms of the seal property, biopsy channel, softness and curvature of gastroscopy body, knob operation, and field of view, the two endoscopic systems were equivalent. In terms of image quality evaluation, including clarity, distortion, color resolution, illumination and quality comprehensive evaluation, the performance of the new portable endoscopic system was similar to that of the Olympus endoscopic system. One pig developed nausea during operation with the Olympus endoscope. No adverse events occurred during operation with the new portable endoscope.Conclusion:The new portable endoscopic system is easy to assemble. In terms of device quality, image quality and safety, the new portable endoscopic system is similar to the clinically used Olympus endoscopic system. Therefore, the new portable endoscope system is safe and effective for upper gastrointestinal endoscopy.
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Objective To explore how to reduce and quickly deal with all kinds of alarm in the dialysis process, to ensure the safety of dialysis, improve the coping ability of nurses, improve the quality of nursing and the satisfaction of patients. Methods Various kinds of alarm and nurse processing time in hemopurification center of our hospital from 2013 to 2014 were recorded and analyzed, the emergency treatment measures were found out, the coping methods were developed, the coping process were improved, and the training of nurses was strengthened. The various parameters were rerecorded and compared after training (2015 to 2016). Results The most common alarm in dialysis process was venous pressure alarm, accounting for 16.45%(15925/96831) of the total alarm, the lowest limit was 10.34%(10020/96831), and the highest limit was 6.11%(5905/96831). The total conductivity alarm was 10.33%(9969/968310), the nurse' s alarm processing time of the lowest limit was (53.11 ± 12.84) s, the highest limit was (136.77 ± 42.88 ) s, the conductivity alarm was (54.17 ± 33.55) s. After the training of nurses, the alarm frequency was reduced (χ2=3.164, P<0.05), the venous pressure alarm accounts for 14.69% (15415/104913) of the total alarm , the lowest limit was 9.52% (9985/104913),and the highest limit was 5.18%(5430/104913), the total conductivity alarm was 7.54%(7913/104913). The alarm processing time was shortened:the lowest limit was (40.94 ± 10.38) s, the highest limit was (119.15 ± 38.79) s (t=3.944, 3.304, P<0.05). The work efficiency and patient satisfaction degree were improved. Conclusions Through the summary and training of all kinds of alarm in the dialysis process, it can effectively reduce the alarm frequency of the dialysis process, improve the work efficiency of nurses, and improve the satisfaction degree of patients.
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Objective To explore how to reduce and quickly deal with all kinds of alarm in the dialysis process, to ensure the safety of dialysis, improve the coping ability of nurses, improve the quality of nursing and the satisfaction of patients. Methods Various kinds of alarm and nurse processing time in hemopurification center of our hospital from 2013 to 2014 were recorded and analyzed, the emergency treatment measures were found out, the coping methods were developed, the coping process were improved, and the training of nurses was strengthened. The various parameters were rerecorded and compared after training (2015 to 2016). Results The most common alarm in dialysis process was venous pressure alarm, accounting for 16.45%(15925/96831) of the total alarm, the lowest limit was 10.34%(10020/96831), and the highest limit was 6.11%(5905/96831). The total conductivity alarm was 10.33%(9969/968310), the nurse' s alarm processing time of the lowest limit was (53.11 ± 12.84) s, the highest limit was (136.77 ± 42.88 ) s, the conductivity alarm was (54.17 ± 33.55) s. After the training of nurses, the alarm frequency was reduced (χ2=3.164, P<0.05), the venous pressure alarm accounts for 14.69% (15415/104913) of the total alarm , the lowest limit was 9.52% (9985/104913),and the highest limit was 5.18%(5430/104913), the total conductivity alarm was 7.54%(7913/104913). The alarm processing time was shortened:the lowest limit was (40.94 ± 10.38) s, the highest limit was (119.15 ± 38.79) s (t=3.944, 3.304, P<0.05). The work efficiency and patient satisfaction degree were improved. Conclusions Through the summary and training of all kinds of alarm in the dialysis process, it can effectively reduce the alarm frequency of the dialysis process, improve the work efficiency of nurses, and improve the satisfaction degree of patients.
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Background: Chronic atrophic gastritis (CAG) is a precancerous lesion of gastric cancer.The diagnostic value of serum gastrin-17 (G-17) level for CAG differs substantioulsy, and Helicobacter pylori (Hp) infection may play an important role.Aims: To explore the effect of Hp infection on serum G-17 level, and the diagnostic value of serum G-17 level for CAG under different Hp infection status.Methods: A total of 204 patients with chronic non-atrophic gastritis and 81 patients with CAG from May 2014 to May 2015 at the three different hospitals were enrolled.Gastroscopy was performed, fasting serum G-17 level, postprandial serum G-17 level and Hp-IgG antibody were determined by ELISA.Results: Fasting serum G-17 level was significantly increased in Hp positive group than in Hp negative group (P=0.001), and postprandial serum G-17 level was significantly decreased in CAG group than in non-atrophy group (P=0.002).AUC of fasting serum G-17 level for diagnosing Hp positive and negative CAG were 0.634 (95% CI: 0.537-0.732) and 0.576 (95% CI: 0.478-0.675), respectively, the accuracy were 62.6% and 54.9%, respectively.AUC of postprandial serum G-17 level for diagnosing Hp positive and negative CAG were 0.675 (95% CI: 0.581-0.769) and 0.595 (95% CI: 0.495-0.694), respectively, the accuracy were 61.8% and 53.1%, respectively.Conclusions: Hp infection has impact on serum G-17 level, as a result, the diagnostic value of G-17 level for CAG is different for patients with and without Hp infection.Diagnostic values of fast and postprandial serum G-17 for Hp positive CAG are higher than Hp negative CAG.
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Objective To evaluate the diagnostic value of gastrin?17( G?17) and pepsinogen( PG) for gastric cancer. Methods A multicenter cross?sectional study of patients with continuous stomach discomfort from four centers including Changhai Hospital Affiliated to Second Military Medical University, the First Hospital Affiliated to Anhui Medical University, Qinghai Provincial People′s Hospital and the First Hospital Affiliated to Zhejiang University of Chinese Medicine from May 2014 to September 2015 was conducted. Before gastroscopy, fasting serum gatrin?17 and pepsinogen were analyzed by enzyme?linked immunosorbent assay(ELISA). The efficacy of G?17 and PG were evaluated according to endoscopic and pathological results. Results Based on the results of the pathological diagnosis, 1 122 cases were enrolled and divided into chronic atrophic gastritis group ( 548 cases ) , chronic non?atrophic gastritis group ( 370 cases), and gastric cancer group(204 cases). Serum G?17 and PGⅡ levels significantly increased(P7 pmol/L and PGR7 pmol/L and PGⅡ>10μg/L was regarded as the cut?off value, the sensitivity, specificity, accuracy, positive predictive value and negative predictive value were 48?04%, 79?74%, 73?98%, 34?51% and 87?35% respectively. If PGR10 μg/L was regarded as the cut?off value, the sensitivity, specificity, accuracy, positive predictive value and negative predictive value were 33?82%, 84?86%, 75?58%, 33?17% and 85?23% respectively. Based on logistic regression analysis of the independent variables of high serum G?17 value(>7 pmol/L), low serum PGR value(10 μg/L), their OR value were 2?592, 2?237 and 1?864 respectively, and high serum G?17 value showed the highest risk of gastric cancer. Conclusion High serum G?17 and PGⅡ, low PGR are indicators of gastric cancer. Combination of G?17 and PGR has the best diagnostic value for gastric cacer. Gastric cancer can be screened in large scale by combining G?17 and PGR in order to improve the early diagnostic rate of gastric cancer and reduce the mortality of gastric cancer in our country.
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Numerous studies showed that changes in serum pepsinogen( PG)and gastrin-17( G-17)levels can reflect histological condition of gastric mucosa,that can be served as serological biopsy of gastric fundic glandular mucosa. The decrease of serum PGⅠ level and PGⅠ/ PGⅡ ratio(PGR)as well as increase of G-17 denotes a high risk of gastric cancer. Helicobacter pylori(Hp)infection can cause chronic active gastritis,and the progress of inflammation can lead to atrophy and intestinal metaplasia of mucosa. This article reviewed the diagnostic value of serum PG,G-17 and Hp antibody for atrophic gastritis and gastric cancer.
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Objective To investigate the correlation of K-ras gene mutations and activation of Hedgehog signaling pathway in pancreatic cancer cell lines.Methods Real-time PCR was used to detect K-ras gene mutations at codon 12 and 13 in pancreatic cancer cell lines of SW1990,PaTu8988,CFPAC-1,PANC1,AsPC-1,Capanc-2,BxPC-3 and the mRNA expression of Glil,Smo in these cell lines.Results The K-ras mutation of PANC1,CFPAC-1,AsPC-1,PaTu8988 was at codon 12,while SW1990 was at codon 13,BxPC-3,Capanc-2 were wild type.The expressions of Glil mRNA of AsPC-1,CFPAC-1,PANC1,PaTu8988,SW1990,BxPC-3,Capanc-2 were 7.84 ± 8.92,1.82 ± 3.45,1.00± 0.00,0.07 ± 0.10,0.88 ± 1.48,0.52 ± 0.98,0.15 ± 0.19,and the expressions of Smo mRNA were 144.00 ± 58.33,3.48 ±3.77,1.00 ±0.00,81.68 ±28.26,0.72 ±0.87,0.34 ±0.60,0.02 ±0.03.Glil,Smo mRNA expressions of cells with wild tpye K-ras were significantly lower than those with mutant type,and wild type BxPC-3's Glil,Smo mRNA expressions were significantly lower than that of mutant AxPC-1 (P ＜ 0.05).Conclusions Activation of Hedgehog signaling pathway may be related to K-ras gene mutations.