Humans ; Early Detection of Cancer ; Endoscopy ; Esophageal Neoplasms/epidemiology* ; Risk Factors ; Mass Screening

Objective:To evaluate the efficacy and safety of a gastric bypass stent system for weight loss and obesity-associated metabolic parameters.Methods:A sub-analysis of a multicenter randomized control trial was conducted on data of 14 obese patients who were implanted the gastric bypass stent system under endoscopy in Beijing Friendship Hospital, Capital Medical University from March 2021 to October 2022. The device was removed after 12 weeks and the patients were followed up for 36 weeks. Outcomes included changes in excess weight loss (EWL), total weight loss (TWL), insulin resistance, liver enzymes, lipids and uric acid at 12, 24 and 36 weeks, and the safety of the device.Results:Among the 14 patients, there were 9 males and 5 females, aged 34.3±7.4 years, with an initial body weight of 104.8±13.9 kg. Stents were removed in advance in 2 patients because of intolerable adverse reactions of the digestive tract. The remaining 12 patients completed follow-up, and their EWL was 34.4%±25.5% at 12 weeks, 39.1%±37.5% at 24 weeks, and 27.3%±40.8% at 36 weeks. TWL was 8.7%±6.2%, 10.1%±10.2% and 8.3%±13.8%, respectively. The levels of homeostasis model assessment of insulin resistance (HOMA-IR) at 12 weeks (4.81±3.71, P=0.022), 24 weeks (4.17±2.77, P=0.002) and 36 weeks (4.66±3.58, P=0.016) were statistically significant compared with baseline (7.03±3.59). The levels of alanine aminotransferase (ALT) were 48 (21-124) U/L, 39 (14-96) U/L, 27 (10-86) U/L and 32 (16-113) U/L at baseline, 12 weeks, 24 weeks and 36 weeks, respectively, and the changes of ALT were statistically significant at 24 weeks and 36 weeks ( P=0.009, P=0.026 compared with baseline). The levels of aspartate aminotransferase (AST) were 30 (20-62) U/L, 24 (15-72) U/L, 22 (11-56) U/L and 26 (13-74) U/L at baseline, 12 weeks, 24 weeks and 36 weeks, respectively, and the change of AST was significant at 24 weeks ( P=0.018 compared with baseline). However, the changes of uric acid and serum lipid were not statistically significant ( P>0.05). The only severe adverse event was esophageal mucosal laceration during the process of explantation, which was successfully treated with endoscopic clips. There was no device migration, acute pancreatitis or hepatic abscess. Conclusion:The gastric bypass stent system, relatively safe, has a good short-term weight loss effect and improves insulin resistance and liver enzymes.

Objective:To assess the current situation, advantages, and difficulties of standardized management in Investigator-Initiated Clinical Trials (IIT).Methods:This article summarized the requirements and policies for clinical research management, the development of clinical research domestically and internationally, the achievements and advantages of clinical research management development in China, and the main problems and difficulties with the standardized IIT management in China, and compiled the experiences and models of several medical institutions in IIT management.Results:While China has a large number of clinical medical publications and is ranked high in the world, the quality of the publications needs to be further improved. Domestic management requirements for IIT were gradually improving, providing a basis for medical institutions to implement standardized management throughout the lifecycle of IIT, and achieve certain progress. However, there were still challenges in the departmental divisions, the unification of management standards, whole-process management and quality control, the scientific review, high-risk project management, and registration.Conclusions:Drawing on the excellent experience of domestic medical institutions, measures including identifying a primary responsible department, establishing unified supervision and inspection standards, and implementing a whole life cycle management may help overcome the challenges in IIT management and improve the quality and efficiency of IIT management.

Purpose To explore the changes in biventricular volume and mass in chronic kidney disease(CKD)patients with preserved ejection fraction using cardiac magnetic resonance(CMR),and evaluate cardiac function using tissue-tracking strain analysis.Materials and Methods The retrospective analysis of 40 CKD patients without symptoms of cardiovascular disease,diabetes and the estimated glomerular filtration rate<60 ml/(min·1.73 m2)who were treated at the First Affiliated Hospital of Anhui Medical University from October 2020 to June 2023 and 25 age-and gender-matched healthy volunteers.All participants underwent 1.5T CMR scans to calculate left and right ventricular function,myocardial strain and native T1 and T2 values,and differences in various imaging parameters between the two groups were compared.Results The native T1 value[(1 109.6±35.9)ms]and T2 value[(58.1±2.9)ms]of CKD patients were significantly higher than those in control group[(1 046.3±15.9)ms,(53.3±2.3)ms](t=8.296,6.916,both P<0.001).The left ventricular end-diastolic volume index,left ventricular end-systolic volume index,left ventricular mass index,right ventricular end-diastolic volume index,right ventricular end-systolic volume index and right ventricular mass index of CKD patients were significantly increased compared with the control group(t=3.233,3.350,5.751,7.746,5.937,2.363,all P<0.05),while the left and right ventricular strain parameters,left ventricular global longitudinal strain,left ventricular global circumferential strain,left ventricular global radial strain,right ventricular global longitudinal strain,right ventricular global circumferential strain and right ventricular global radial strain were significantly decreased(t=9.506,9.072,-10.603,10.496,11.574,-4.018,all P<0.001),and the estimated glomerular filtration rate exhibited significant correlations with left ventricular global longitudinal strain(r=-0.636),left ventricular global radial strain(r=0.688),right ventricular global longitudinal strain(r=-0.513),right ventricular global circumferential strain(r=-0.827)and right ventricular global radial strain(r=0.514)(all P<0.001).Conclusion CMR can quantitatively assess myocardial fibrosis and edema in patients with CKD,and tissue tracking strain analysis can detect myocardial motion abnormalities before changes in ventricular ejection fraction,offering value in the early detection of cardiac involvement in CKD patients..

Background::Erosive esophagitis (EE) is a gastroesophageal reflux disease characterized by mucosal breaks in the esophagus. Proton pump inhibitors are widely used as maintenance therapy for EE, but many patients still relapse. In this trial, we evaluated the noninferiority of vonoprazan vs. lansoprazole as maintenance therapy in patients with healed EE. Methods::We performed a double-blind, double-dummy, multicenter, phase 3 clinical trial among non-Japanese Asian adults with endoscopically confirmed healed EE from April 2015 to February 2019. Patients from China, South Korea, and Malaysia were randomized to vonoprazan 10 mg or 20 mg once daily or lansoprazole 15 mg once daily for 24 weeks. The primary endpoint was endoscopically confirmed EE recurrence rate over 24 weeks with a noninferiority margin of 10% using a two-sided 95% confidence interval (CI). Treatment-emergent adverse events (TEAEs) were recorded.Results::Among 703 patients, EE recurrence was observed in 24/181 (13.3%) and 21/171 (12.3%) patients receiving vonoprazan 10 mg or 20 mg, respectively, and 47/184 (25.5%) patients receiving lansoprazole (differences: -12.3% [95% CI, -20.3% to-4.3%] and -13.3% [95% CI, -21.3% to -5.3%], respectively), meeting the primary endpoint of noninferiority to lansoprazole in preventing EE recurrence at 24 weeks. Evidence of superiority (upper bound of 95% CI <0%) was also observed. At 12 weeks, endoscopically confirmed EE recurrence was observed in 5/18, 2/20, and 7/20 of patients receiving vonoprazan 10 mg, vonoprazan 20 mg, and lansoprazole, respectively. TEAEs were experienced by 66.8% (157/235), 69.0% (156/226), and 65.3% (158/242) of patients receiving vonoprazan 10 mg, vonoprazan 20 mg, and lansoprazole, respectively. The most common TEAE was upper respiratory tract infection in 12.8% (30/235) and 12.8% (29/226) patients in vonoprazan 10 mg and 20 mg groups, respectively and 8.7% (21/242) patients in lansoprazole group.Conclusion::Vonoprazan maintenance therapy was well-tolerated and noninferior to lansoprazole for preventing EE recurrence in Asian patients with healed EE.Trial Registration::https://clinicaltrials.gov; NCT02388737.

Background::The incidence and mortality of colorectal cancer (CRC) in China are increasing in recent years. The clarified pathogenesis and detectable precancerous lesions of CRC make it possible to prevent, screen, and diagnose CRC at an early stage. With the development of endoscopic and surgical techniques, the choice of treatment for early CRC is also worth further discussion, and accordingly, a standard follow-up program after treatment needs to be established.Methods::This clinical practice guideline (CPG) was developed following the recommended process of the World Health Organization, adopting Grading of Recommendations Assessment, Development and Evaluation (GRADE) in assessing evidence quality, and using the Evidence to Decision framework to formulate clinical recommendations, thereby minimizing bias and increasing transparency of the CPG development process. We used the Reporting Items for practice Guidelines in HealThcare (RIGHT) statement and Appraisal of Guidelines for Research and Evaluation II (AGREE II) as reporting and conduct guides to ensure the guideline’s completeness and transparency.Results::This CPG comprises 46 recommendations concerning prevention, screening, diagnosis, treatment, and surveillance of CRC. In these recommendations, we have indicated protective and risk factors for CRC and made recommendations for chemoprevention. We proposed a suitable screening program for CRC based on the Chinese context. We also provided normative statements for the diagnosis, treatment, and surveillance of CRC based on existing clinical evidence and guidelines.Conclusions::The 46 recommendations in this CPG are formed with consideration for stakeholders’ values and preferences, feasibility, and acceptability. Recommendations are generalizable to resource-limited settings with similar CRC epidemiology pattern as China.

Objective:To evaluate the diagnostic efficacy of brush cytology and transpapillary biopsy sampling under the guidance of endoscopic retrograde cholangiopancreatography (ERCP) in distinguishing between benign and malignant biliary strictures.Methods:A total of 470 patients with unknown biliary strictures who underwent ERCP at Department of Gastroenterology, Beijing Friendship Hospital from January 2013 to January 2022 were enrolled. Brush cytology was performed before biopsy in a single procedure, and with multiple ERCP brush cytologies or biopsy performed for challenging cases. Clinical data, ERCP procedures, pathological results, and follow-up data were collected. With the final diagnosis as the golden standard, the diagnostic efficacy of brush cytology and biopsy sampling were calculated.Results:The final diagnosis showed 251 cases of malignant and 219 cases of benign biliary strictures. All 470 patients received brush cytology, among whom, 37 patients underwent multiple brush cytologies. Additionally, 114 patients were treated with biopsy sampling. The single brush cytology showed a sensitivity of 49.40% (124/251) and a specificity of 99.09% (217/219) for diagnosing malignant biliary strictures. Multiple brush cytologies showed a sensitivity of 68.42% (13/19) and a specificity of 100.00% (18/18). Biopsy sampling showed a sensitivity of 68.18% (45/66) and a specificity of 97.92% (47/48). Among the 114 patients who underwent both brush cytology and biopsy sampling, the results showed that the diagnostic sensitivity of brush cytology combined with biopsy sampling [77.27% (51/66)] and the sensitivity of single biopsy sampling [68.18% (45/66)] were significantly higher than that of single brush cytology [43.94% (29/66), χ 2=13.99, P<0.001; χ 2=6.92, P=0.009]. Conclusion:Combining brush cytology and biopsy forceps during ERCP enhances diagnostic sensitivity in identifying malignant biliary strictures. Biopsy sampling stands out as more sensitive compared with single brush cytology, emphasizing its role in improving diagnostic capabilities.

Objective:To assess the correlation and consistency between the cancer risk-oriented endoscopic Kimura-Takemoto classification and the operative link for gastritis assessment (OLGA) in risk stratification of gastric cancer in patients with chronic gastritis after Helicobacter pylori ( H. pylori) eradication. Methods:From January 1, 2018 to October 31, 2021, 97 patients with chronic gastritis who successfully underwent H. pylori eradication at Beijing Friendship Hospital affiliated to Capital Medical University were selected. During the follow-up period, all patients underwent standardized magnifying endoscopy to assess gastric mucosal atrophy with the Kimura-Takemoto classification, which was classified as no or mild atrophy, moderate atrophy, and severe atrophy. Additionally, according to the new Sydney staging system, endoscopic biopsies were conducted at 5 sites of the patients to classify into OLGA stages 0, Ⅰ, Ⅱ, Ⅲ, or Ⅳ. Spearman rank correlation analysis and Kappa consistency test were performed to evaluate the correlation and consistency between the 2 evaluation systems, respectively. Area under the curve (AUC) of the receiver operating characteristic curve was used to calculate the predictive ability of the grading of gastric mucosal atrophy under endoscopy in high-risk histological staging. Furthermore, multivariate logistic regression analysis was used to assess factors influencing the consistency of the 2 evaluation systems. Chi-square test or Fisher′s exact test were used for statistical analysis. Results:Longitudinal follow-up was completed in 97 cases, with a follow-up time of (37.38±13.18) months after H. pylori eradication. The proportion of OLGA stage Ⅲ to Ⅳ in patients with no or mild atrophy (21.7%, 10/46) was lower than that in patients with moderate and severe atrophy (63.0%, 29/46 and 5/5, respectively), and the differences were statistically significant( χ2=16.07 and 13.30, both P<0.001). However, there was no significant difference in distribution of OLGA staging between patients with moderate atrophy and patients with severe atrophy (all P>0.05). The consistency rate of high-risk assessment for gastric cancer between the 2 evaluation systems was 73.2% (71/97). The correlation between the Kimura-Takemoto classification and OLGA staging was moderate ( r=0.47, 95% confidence interval(95% CI) 0.30 to 0.61, P<0.001). The result of consistency test indicated that the consistency of the 2 evaluation systems was moderate, and the Kappa value was 0.46 (95% CI 0.29 to 0.64, P<0.001). For patients with chronic gastritis after H. pylori eradication, the sensitivity of Kimura-Takemoto classification of moderate to severe atrophy under endoscopy in identifying high-risk of OLGA stages was 77.21% (95% CI 62.16% to 88.53%), the specificity was 69.81% (95% CI 55.66% to 81.66%), and the AUC was 0.735 (95% CI 0.636 to 0.820, P<0.01). As the time after H. pylori eradication increased (post- H. pylori eradication less than 18, 18 to 36, and more than 36 months), the consistency of atrophy assessment between the Kimura-Takemoto classification and OLGA staging reduced (7/8, 84.4% (27/32), 64.9% (37/57), respectively), and the difference was statistically significant ( χ2=4.36, P=0.037). The result of multivariate logistic regression analysis revealed that the time after H. pylori eradication more than 36 months ( OR=3.443, 95% CI 1.117 to 10.614, P=0.031) and gastric ulcer ( OR=3.928, 95% CI 1.177 to 13.110, P=0.026) were independent factors influencing the consistency between the Kimura-Takemoto classification and OLGA staging. Conclusions:The endoscopic and histological changes of chronic gastritis after eradication of H. pylori are consistent. Within short period after H. pylori eradication (no more than 36 months), the sensitivity of high-risk classification under endoscopy is high and the specificity is moderate, which can predict high-risk histological staging to a certain degree.

Objective:To evaluate the effects of hemoclips on preventing delayed bleeding for early gastric cancer (EGC) after endoscopic submucosal dissection (ESD).Methods:Clinical data of 459 patients who underwent ESD for EGC in Beijing Friendship Hospital from June 2013 to August 2020 were collected retrospectively. Patients were divided into group A (hemoclip group, n=162) and group B (non-hemoclip group, n=297) according to whether preventive hemostatic clip treatment was performed after resection. Delayed bleeding within 2 weeks after ESD was observed. Univariate analysis and subgroup analysis were conducted for the delayed bleeding incidence and clinicopathological features. Results:Delayed bleeding incidences of group A and group B were 3.1% (5/162) and 8.1% (24/297) with significant difference between the two groups ( χ2=4.418, P=0.036). Subgroup analysis showed that there were significant differences in the delayed bleeding incidence between the two groups when the diameter of the tumor >20 mm [3.5% (2/57) VS 15.3% (13/85), χ2=5.016, P=0.025], the tumor located in the lower part of the stomach [1.0% (1/97) VS 10.4% (20/192), χ2=8.425, P=0.004], and the depth of tumor invasion was M/SM1 [3.2% (5/157) VS 8.1% (23/285), χ2=4.072, P=0.044]. There were no significant differences in the delayed bleeding incidence between group A and group B when the diameter of the tumor ≤20 mm, the tumor located in the upper/medial part of the stomach and the depth of tumor invasion was SM2 ( P>0.05). Conclusion:Hemoclips can prevent delayed bleeding after ESD for EGC, which is mainly observed in a tumor of diameter >20 mm, located in the lower part of the stomach and M/SM1 tumor invasion. It has little effect on the prevention when the tumor diameter ≤20 mm and located in the upper/medial part of the stomach.

Objective:To evaluate the application of three-dimensional (3D) imaging device to colonoscopy.Methods:A total of 60 patients who underwent painless colonoscopy in Beijing Friendship Hospital, Capital Medical University from November to December, 2019 were enrolled and divided into 2 groups according to random code. Each patient underwent colonoscopy twice, while 2D colonoscopy was used for cecal intubation. Thirty patients were assigned to the experimental group (primary withdrawal used 3D colonoscopy, and secondary withdrawal used 2D colonoscopy), and 30 others to the control group (primary withdrawal used 2D colonoscopy, and secondary withdrawal used 3D colonoscopy). The detection of polyps, the withdrawal time, operating experience, image quality and complication were evaluated in the two groups.Results:The polyp detection rate at the first colonoscopy in the experimental group was 77.3% (17/22), which was higher than 43.5% (10/23) in the control group ( χ2=5.351, P=0.021). Ten operators in the experimental group had dizziness, while the operators in the control group had no dizziness ( P=0.001). There were no significant differences between the two groups in the polyp diameter [0.50 (0.70) cm VS 0.30 (0.20) cm, U=57.000, P=0.170], withdrawal time (4.6±1.5 min VS 5.2±1.9 min, t=-1.189, P=0.239) or image quality (27 cases with 3 points in the identification of lesion nature, and 28 cases with 3 points in the identification of duct both in the two groups, P=1.000) at the first colonoscopy. No complication occurred in either group. Conclusion:Application of 3D imaging device is feasible for colonoscopic polyp detection, and it can be used in clinical practice.