Diagnostic value of the new optical staining technology for domestic endoscope: a multicenter clinical study / 中华消化内镜杂志

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.