ABSTRACT
Objective:A prospective, multicenter randomized controlled clinical research was conducted to explore the diagnostic value of the new optical staining technology for domestic endoscope, spectral focused imaging (SFI) and variable intelligent staining technology (VIST), for gastric precancerous lesions.Methods:Patients who intended to undergo gastroscopy between August 2020 and May 2021 were randomly divided into the white light group and the new optical staining group at the First Hospital of Hebei Medical University, Shanghai Tenth People's Hospital and the Second Affiliated Hospital of Soochow University. A sequential examination method was applied (white light to new optical staining or new optical staining to white light). The endoscopic diagnostic results and the detection results of Helicobacter pylori ( HP) of the two groups were recorded. At the same time, such five variables as gastric mucosal atrophy, intestinal metaplasia, fold enlargement, nodular gastritis and diffuse redness were evaluated for the risk of gastric cancer in the two groups. Results:A total of 419 cases were enrolled, including 208 cases in the white light group and 211 cases in the new optical staining group. Compared with pathological findings, the detection rates of gastric inflammation, atrophy, intestinal metaplasia, low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia and advanced cancer lesions in the white light group were 28.9%, 40.4%, 64.9%, 17.8%, 0.5% and 0.5% respectively; while those in the new optical staining group were 30.8%, 42.7%, 62.6%, 15.2%, 2.8% and 0.5%. There were no significant differences in the detection rates between the two groups ( P>0.05). Compared with pathology, the sensitivity, the specificity, the accuracy, the positive predictive value and the negative predictive value for gastric mucosal atrophy in the white light group were 92.9%, 61.3%, 74.0%, 61.9% and 92.7% respectively and those in the new optical staining group (SFI mode) were 94.4%, 64.5%, 77.3%, 66.4% and 94.0% respectively. The above 5 measures for gastric mucosal intestinal metaplasia were 68.1%, 72.6%, 69.7%, 82.1% and 55.2% in the white light group, and 87.1%, 89.9%, 88.2%, 93.5% and 80.7% in the new optical staining group (VIST mode), with significant difference between the two groups ( P<0.05). In terms of HP infection with 13C-urea breath test ( 13C-UBT) results as the gold standard, the above 5 measures were 90.2%, 84.3%, 87.4%, 86.8% and 88.2% in the white light group and 92.6%, 77.1%, 85.4%, 82.2% and 90.1% in the new optical staining group respectively. The proportion of high-risk gastric lesions in the new optical staining group was higher in cases of a gastric cancer risk score≥ 4 ( P<0.05). Conclusion:The new optical staining technology of domestic endoscopy has higher diagnostic value for gastric mucosal intestinal metaplasia. Gastroscopy is helpful for the detection of precancerous lesions with gastric cancer risk score as a tool. The new optical staining technology of domestic endoscopy is similar to imported endoscopy in diagnosing gastric precancerous lesions and HP infection, which is an effective means to detect gastric mucosal precancerous lesions.
ABSTRACT
Objective To evaluate the potential differences in serum proteomic profiles between patients with esophageal squamous cell carcinoma(ESCC)and precancerous lesions in order to establish proteomic pattern model for diagnosis of ESCC and precancerous lesions in high risk area,and to investigate its value in screening ESCC.Methods The serum and endoscopic biopsy samples were obtained from 38 normal controls,63 patients with atypical hyperplasia(class Ⅰ 26 cases,class Ⅱ 26 cases,class Ⅲ 11 cases)and 36 patients with advanced esophageal carcinoma.The serum proteomic patterns were examined using surface enhanced laser desorption/ionization time of flight mass spectrometry(SELDI-TOF-MS)and CM10 protein chip.The data was analyzed and disease diagnostic models were established using support vector machine(SVM).The diagnostic model was evaluated and validated by leave one cross validation.Results ①The diagnostic model could differentiate advanced esophageal carcinoma from normal controls with a specificity of 89.47%and a sensitivity of 83.33%.②The results delivered 92.31%,80.77% and 90.91%specificity,and 80.56%,83.33%and 94.44%sensitivity for discrimination of atypical hyperplasia Ⅰ,Ⅱand Ⅲ,respectively,using diagnostic models.③Four(4291,5644,5664,8775)m/z peaks observed repeatedly using diagnostic models.Conclusions The SELDI-TOF-MS and SVM provide a new approach for discrimination of ESCC and precancerous lesions in high risk area.Four(4291,5644,5664,8775)m/z peaks may considered as potential biomarkers which related to the ESCC and esophageal precancerous lesions.