With the extensive application of surgical robots represented by Da Vinci in minimally invasive surgical procedures, robotic technology has gradually extended to the field of flexible endoscopic surgery like digestive endoscopy. Many studies have shown that surgical robots can also improve the operational efficiency and safety of flexible endoscopic surgery and optimize the learning curve. However, due to the narrow and tortuous lumen of digestive tract, the development and design of flexible digestive endoscopic surgical robot is relatively more difficult. In this paper, the research and development characteristics of the flexible digestive endoscopic surgical robot are introduced from the aspects of carrier length, flexibility and ergonomics, and its future clinical application is prospected, with a view to facilitating the application of the flexible surgical robot in the minimally invasive surgical procedures of natural passages such as digestive, respiratory and urinary tract.

With the extensive application of surgical robots represented by Da Vinci in minimally invasive surgical procedures, robotic technology has gradually extended to the field of flexible endoscopic surgery like digestive endoscopy. Many studies have shown that surgical robots can also improve the operational efficiency and safety of flexible endoscopic surgery and optimize the learning curve. However, due to the narrow and tortuous lumen of digestive tract, the development and design of flexible digestive endoscopic surgical robot is relatively more difficult. In this paper, the research and development characteristics of the flexible digestive endoscopic surgical robot are introduced from the aspects of carrier length, flexibility and ergonomics, and its future clinical application is prospected, with a view to facilitating the application of the flexible surgical robot in the minimally invasive surgical procedures of natural passages such as digestive, respiratory and urinary tract.

Objective:To develop a novel, flexible, dual-arm, master-slave digestive endoscopic minimally invasive surgical robot system named dual-arm robotic endoscopic assistant for minimally invasive surgery (DREAMS) and to evaluate its feasibility for endoscopic submucosal dissection (ESD) by using ex vivo porcine stomachs.Methods:A novel endoscopic robot (DREAMS) system was developed which was composed of a flexible two-channel endoscope, two flexible robotic manipulators, a master controller, a robotic arm, and a control system. A total of 10 artificial round-like lesions with diameters ranging from 15 to 25 mm were created (5 in gastric antrum and 5 in gastric body) by using fresh peeled stomach of healthy pigs as the model. Submucosal dissection was performed with the assistance of the DREAMS system by two operators. The main outcome was submucosal dissection speed, and the secondary outcomes included muscular injury rate, perforation rate, and grasping efficiency of the robot.Results:All 10 lesions were successfully dissected en bloc by using the DREAMS system. The diameter of the artificial lesions was 22.34±2.39 mm, dissection time was 15.00±8.90 min, submucosal dissection speed was 141.79±79.12 mm 2/min, and the number of tractions required by each ESD was 4.2 times. Muscular injury occurred in 4/10 cases of ESD. No perforation occurred. Conclusion:The initial animal experiment shows the DREAMS system is safe and effective.

Objective:To explore the feasibility of smart phone real-time picture exchange-assisted telecytopathology for rapid on-site evaluation (tele-ROSE), and the role of tele-ROSE in improving the diagnostic efficiency of endoscopic physicians.Methods:Data of patients who underwent endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) from April 2020 to May 2021 in Qilu Hospital of Shandong University were retrospectively collected. Patients who didn't receive ROSE from April 2020 to October 2020 were enrolled in the non-ROSE group, and those who underwent ROSE from November 2020 to May 2021 were enrolled in the ROSE group, of which endosonographers used WeChat on the smartphone to send ROSE images to cytopathologists from November 2020 to March 2021 were the mobile phone group, and those whose ROSE results independently diagnosed by trained endosonographers from April 2021 to May 2021 were the self-ROSE group. Basic information, ROSE results, postoperative pathology and follow-up were compared, and the diagnostic effectiveness of tele-ROSE was analyzed.Results:A total of 188 cases were included, of which 179 cases (95.2%) were solid pancreatic lesions and 9 (4.8%) were enterocoelia lesions. There was no significant difference in the puncture time among the non-ROSE, mobile phone and self-ROSE groups [3 (3, 4) VS 3 (3, 4) VS 3 (2, 4), H=1.320, P=0.517]. With the final diagnosis as the golden standard, the sensitivity, the specificity, the accuracy, the positive predictive value, the negative predictive value and Kappa value of the non-ROSE group were 80.6% (58/72), 89.5% (17/19), 82.4% (75/91), 96.7% (58/60), 54.8% (17/31), and 0.6 respectively. The corresponding indices in the ROSE group were 97.4% (74/76), 100.0% (21/21), 97.9% (95/97), 100.0% (74/74), 91.3% (21/23), and 0.9 respectively, those of the mobile phone group were 95.2% (40/42), 100.0% (10/10), 96.2% (50/52), 100.0% (40/40), 83.3% (10/12), and 0.9 respcetively, and those of the self-ROSE group were 100.0% (34/34), 100.0% (11/11), 100.0% (45/45), 100.0% (34/34), 100.0% (11/11), and 1.0 respectively. The sensitivity ( P=0.002), the accuracy ( P=0.001) and the negative predictive value ( P=0.009) of the ROSE group were significantly higher than those of the non-ROSE group, and there was no significant difference in other diagnostic efficacy indices ( P>0.05). There was no significant difference between the mobile phone group and the self-ROSE group in diagnostic efficacy ( P>0.05). Conclusion:Instant smartphone-assisted tele-ROSE through WeChat can well meet the needs of pathologists and endoscopic physicians. After the application of tele-ROSE training, the diagnostic accuracy of endoscopic physicians is equivalent to that of cytopathologist, which helps to obtain more sufficient specimens under endoscopy and improve the diagnostic accuracy of EUS-FNA.

Bismuth-containing quadruple therapy (BQT) has long been recommended for Helicobacter pylori ( H. pylori ) eradication in China. Meanwhile, in the latest national consensus in China, dual therapy (DT) comprising an acid suppressor and amoxicillin has also been recommended. In recent years, the eradication rate of H. pylori has reached >90% using DT, which has been used not only as a first-line treatment but also as a rescue treatment. Compared with BQT, DT has great potential for H. pylori eradication; however, it has some limitations. This review summarizes the development of DT and its application in H. pylori eradication. The H. pylori eradication rates of DT were comparable to or even higher than those of BQT or standard triple therapy, especially in the first-line treatment. The incidence of adverse events associated with DT was lower than that with other therapies. Furthermore, there were no significant differences in the effects of dual and quadruple therapies on gastrointestinal microecology. In the short term, H. pylori eradication causes certain fluctuations in the gastrointestinal microbiota; however, in the long term, the gastrointestinal microbiota eventually returns to its normal state. In the penicillin-naïve population, patients receiving DT have a high eradiation rate, better compliance, lower incidence of adverse reactions, and lower primary and secondary resistance to amoxicillin. These findings suggest the safety, efficacy, and potential of DT for H. pylori eradication.
Humans ; Helicobacter Infections/drug therapy* ; Anti-Bacterial Agents/pharmacology* ; Helicobacter pylori ; Proton Pump Inhibitors ; Drug Therapy, Combination ; Amoxicillin/therapeutic use* ; Treatment Outcome

Objective:Based on the artificial intelligence (AI) technology in endoscopy and the internet platform, to explore and construct a safe, standardized, scientific and rigorous database for digestive endoscopy, and to provide reference and evidence for the data quality control of AI in digestive endoscopy in China.Methods:After referring to relevant guidelines and standards, data collection and labelling standards of digestive endoscopy of 12 common gastrointestinal diseases were determined. The software of online collection and labelling of multi-center digestive endoscopy data in Shandong Province was developed. Endoscopic equipment with a domestic market share of >5% was used and dozens of experienced endoscopists from 9 medical centers in Shandong Province were uniformly trained for data labelling. From July 2019 to July 2020, the endoscopic examination data from 9 medical centers including Qilu Hospital of Shandong University, Shandong Provincial Hospital , Liaocheng People′s Hospital, Linyi People′s Hospital, Weihai Municipal Hospital, Taian City Central Hospital, Binzhou Medical University Hospital, Yantai Yuhuangding Hospital and Qilu Hospital of Shandong University (Qingdao) were prospectively and continuously collected and labeled. The optimized, desensitized, and generalized data were uploaded to the server. After the file synchronization, data processing, and expert review, a multi-center digestive endoscopy AI database with standard data collection and labelling in Shandong Province was constructed, namely cloud platform. Descriptive methods were used for statistical analysis.Results:The collection and labelling standards for multi-center digestive endoscopy AI data in Shandong province was established. The software of online collection and labelling of multi-center digestive endoscopy AI data in Shandong province was developed. The database in Shandong province was successfully constructed. In the database, 43 010 lesions, 40 353 images, and 11 289 examinations were labeled. Among them, there were 2 906 cases of early esophageal cancer, 2 912 cases of early gastric cancer, 2 397 cases of early colorectal cancer, and 9 773 cases of colorectal polyps (5 539 cases of adenomatous polyps, 1 161 cases of non-adenomatous polyps and 3 073 case of undetermined polyps).Conclusions:The multi-center AI cloud platform for digestive endoscopy in Shandong Province adopts unified standards and collection and labeling software, which ensures the safety and standardization of endoscopy data. It provides a reference and basis for the construction of a quality control system for standardized data collection and labelling of digestive endoscopy AI data in our country and for the third-party data supervision.

Objective:To explore the efficacy and safety of Ganhai Weikang capsule (GWC) in the treatment of functional dyspepsia (FD).Methods:A randomized, double-blind, placebo-controlled parallel, multi-center, superiority clinical trial was conducted. From March 2018 to April 2020, totally 324 patients with dyspepsia symptoms, who were diagnosed as chronic non-atrophic gastritis by endoscopy and pathology and met the Rome Ⅳ diagnostic criteria for FD from 7 top hospitals were enrolled, including the First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital), Heilongjiang Hospital of Traditional Chinese Medicine, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Qilu Hospital of Shandong University, the First Affiliated Hospital of Zhejiang University, Beijing Hospital of Traditional Chinese Medicine of Capital Medical University and the Third Xiangya Hospital of Central South University. The patients were randomly divided into the GWC group and the placebo group according to the ratio of 1∶1. The patients of GWC group were given GWC and the patients of placebo group were given GWC capsule simulant. The patients of both groups orally took capsules before meals, 2.4 g each time and 3 times per day, and the course of treatment was 4 weeks. The main efficacy index was the total clinical effective rate after 4 weeks, and the secondary efficacy index was the changes of clinical symptom scores of upper abdominal pain, upper abdominal burning, postprandial fullness and early satiety. The safety index included laboratory tests and adverse events. Chi-square test and Wilcoxon rank sum test were used for statistical analysis.Results:A total of 320 FD patients were enrolled in the full analysis set (FAS), which included 161 cases in GWC group and 159 cases in placebo group. A total of 298 cases were in the per-protocol set (PPS), 149 cases each in GWC group and placebo group. The results of FAS and PPS both showed that the total clinical effective rates of the GWC group were higher than those of the placebo group (84.5%, 136/161 vs. 44.0%, 70/159 and 83.9%, 125/149 vs. 46.3%, 69/149), and the differences were statistically significant ( χ2=57.07 and 46.32, both P<0.001). In addition, the differences of the total score of main symptoms and each symptom (upper abdominal pain, upper abdominal burning, postprandial fullness and early satiety) before and after treatment of GWC group were all higher than those of the placebo group (FAS: 10 (7, 14) vs. 5 (3, 11); 3 (2, 4) vs. 2 (0, 3); 2 (0, 4) vs. 1 (0, 3); 3 (1, 4) vs. 2 (1, 3); 2 (0, 4) vs. 1 (0, 3). PPS: 10 (7, 13) vs. 5 (3, 11); 3 (2, 4) vs. 2 (0, 3); 2 (0, 4) vs. 1 (0, 2); 3 (1, 4) vs. 2 (1, 3); 2 (0, 4) vs.1 (0, 3)), and the differences were statistically significant (FAS: Z=5.80, 5.91, 3.19, 3.72 and 3.30; PPS: Z=5.14, 5.11, 2.86, 3.21 and 2.84; all P<0.01). The results of FAS and PPS indicated that the improvement rates of main symptoms and each symptom (upper abdominal pain, upper abdominal burning, postprandial fullness and early satiety) of GWC group were all higher than those of the placebo group (FAS: 77.8% (54.6%, 91.3%) vs. 42.9% (28.6%, 61.5%); 100.0% (60.0%, 100.0%) vs. 50.0% (25.0%, 60.0%); 100.0% (50.0%, 100.0%) vs. 50.0% (25.0%, 100.0%); 71.4% (33.3%, 100.0%) vs. 41.4% (25.0%, 66.7%); 100.0% (50.0%, 100.0%) vs. 50.0% (20.0%, 100.0%). PPS: 77.8% (54.2%, 89.5%) vs. 44.0% (28.6%, 65.0%); 100.0% (60.0%, 100.0%) vs. 50.0% (25.0%, 100.0%); 100.0% (50.0%, 100.0%) vs. 50.0% (25.0%, 100.0%); 71.4% (33.3%, 100.0%) vs. 46.4% (25.0%, 66.7%); 100.0% (50.0%, 100.0%) vs. 50.0% (20.0%, 100.0%)), and the differences were statistically significant (FAS: Z=8.60, 7.72, 4.98, 4.24 and 5.61; PPS: Z=7.90, 7.03, 4.49, 3.88 and 4.83; all P<0.001). After 2 weeks of treatment, the differences of the total score of main symptoms and score of each symptom (upper abdominal pain, upper abdominal burning and early satiety) before and after treatment of GWC group were all higher than those of the placebo group (5.0 (3.0, 8.0) vs. 4.0 (2.0, 6.0); 2.0 (1.0, 2.0) vs. 2.0 (0.0, 2.0); 1.5 (0.0, 2.0) vs. 1.0 (0.0, 2.0); 1.5 (0.0, 2.0) vs. 1.0 (0.0, 2.0)), and the differences were statistically significant ( Z=2.95, 3.44, 2.43 and 2.79, all P<0.05). There was no significant difference in the incidence of adverse events between the GWC group and the placebo group (0.6%, 1/163 vs. 0, 0/159). Conclusion:The clinical total effective rate of GWC in the treatment of FD is superior to that of placebo and it has good safety.

AIM: To evaluate the effect of TDF withdrawal time on changes of serum HBV-M, HBV DNA and ALT level in the mother-to-child blocking of the maternal population. METHODS: A prospective, randomized and controlled study was conducted. The 120 pregnant women with HBV who took TDF during 24 to 28 weeks of gestation were randomly divided into group A (withdrawal at delivery) and group B (withdrawal at 4 weeks postpartum), levels of HBV-M, HBV DNA, and ALT at different times were detected. The results were statistically analyzed by Wilcoxon Rank-sum test and χ

Objective:To evaluate the diagnostic efficiency of hypersensitivity quantitative fecal immunochemical test (hs-qFIT) in colorectal cancer (CRC) and advanced adenoma.Methods:From July to December 2020, consecutive patients aged 50 to 75 years who underwent colonoscopy in Qilu Hospital of Shandong University, and had the Asia-Pacific colorectal screening score of medium or high risk were enrolled. All patients were requested to complete two hs-qFIT before colonoscopy. The diagnostic efficacy of hs-qFIT for CRC and advanced adenoma were assessed. Receiver operating characteristic curve of hs-qFIT in CRC diagnosis was drawn and the area under the curve (AUC) was calculated.Results:A total of 811 patients including 20 (2.5%) cases of CRC, 47 (5.8%) cases of advanced adenoma, 206 (25.4%) cases of non-advanced adenoma, 219 (27.0%) cases of non-adenomatous polyp, 76 (9.4%) cases of other colorectal lesions and 243 (30.0%) cases of non-colorectal lesions were involved. When the fecal hemoglobin cut-off values were 10, 30, 50, 75 and 100 ng/mL, the positive rates of hs-qFIT detection were 17.9% (145/811), 10.9% (88/811), 8.3% (67/811), 7.4% (60/811) and 5.8% (47/811), respectively. When the cut-off value of fecal hemoglobin decreased from 100 ng/mL to 10 ng/mL, the sensitivity of hs-qFIT for CRC diagnosis increased from 90.0% to 100.0%, and the specificity decreased from 96.3% to 84.2%; and the sensitivity of hs-qFIT for the diagnosis of advanced adenoma increased from 19.1% to 66.0%, and the specificity decreased from 95.0% to 85.1%. The AUC of hs-qFIT for the diagnosis of CRC and advanced adenoma were 0.981 (95% confidence interval ( CI) 0.970 to 0.992) and 0.846 (95% CI 0.807 to 0.886), respectively. When the optimal cut-off values were taken, the sensitivity and specificity were 100.0% and 91.2% for the diagnosis of CRC, and 66.0% and 85.3% for the diagnosis of advanced adenoma, respectively. Conclusion:Hs-qFIT can help the early screening of CRC and advanced adenoma.

Objective:To develop intelligent quality-control system (IQCS) based on deep convolutional neural networks (DCNN), and to prospectively evaluate the clinical feasibility of this system.Methods:Aimed at quality control objectives during gastroscopy such as the observation integrity of gastric mucosal, gastric mucosa visibility, time spent on gastroendoscopy and suspicious gastric cancer detection, four DCNN models including gastroscopic scanning location recognition model, gastric mucosa visibility recognition model, in vivo and in vitro identification model and gastric cancer detection model were designed. A total of 98 385 white light gastroscopy images were retrospectively collected from multiple centers for training and testing the DCNN models. The accuracy, sensitivity and specificity of each model were calculated and the receiver operating characteristic (ROC) curve was drawn. The models were integrated and formed the multi-function integrated IQCS. At the center of gastroendoscopy, Qilu Hospital of Shandong University, 100 consecutive patients who underwent routine gastroscopy were prospectively enrolled. The feasibility of IQCS in real clinical practice was evaluated. The condition of each quality control function of the system (average error point out or correct rate) and the detection of lesions after the examination were recorded. Results:The accuracy, sensitivity and specificity of the model of gastroscopic scanning location recognition to identify each site were 98.40% to 99.85%, 61.95% to 100.00% and 98.65% to 100.00%, respectively; the area under curve (AUC) of ROC curve ranged from 0.997 6 to 1.000 0. The accuracy, sensitivity and specificity of the model of gastric mucosa visibility recognition to identity the mucosal visibility were 97.02% to 98.27%, 85.14% to 99.28% and 93.72% to 100.00%, respectively. The accuracy, sensitivity and specificity of the model of in vivo and in vitro identification were 97.27%, 99.85% and 94.50%, respectively; the AUC of ROC was 0.961 5. The accuracy, sensitivity and specificity of the model of gastric cancer detection were 95.92%, 95.64% and 96.05%, respectively; the AUC of ROC was 0.975 9. The results of feasibility evaluation of IQCS indicated that in the quality control of gastric mucosa observation integrity, the system average error was 0.32 time/case; in the quality control of mucosal visibility, the system average error was 0.47 time/case; the correct rate of intelligent timing during gastroscopy was 96.00%, in the quality control of suspicious gastric cancer detection, the system average error was 0.36 time/case. A total of 3 cases of gastric cancer and 1 case of high grade gastric intraepithelial neoplasia were detected. The system could accurately identify the location. Conclusions:Gastroscopy IQCS can accurately achieve quality control in the observation integrity of gastric mucosa, gastric mucosa visibility, time spent on gastroendoscopy and suspicious gastric cancer detection in actual examination, which makes accurate and efficient gastroscopy quality control possible.