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.

To meet China′s requirements for scientific and technological innovation and high-quality development in the new era, it is imperative to actively implement the innovation-driven development strategy and build high-level research hospitals. Beijing Friendship Hospital, Capital Medical University has been working to build a research hospital since 2018. The hospital promoted discipline construction through the development mode of discipline clusters, made the research wards as a platform, adopted the " shared comprehensive service" mode to improve the quality and efficiency of clinical research, and strengthened talent cultivation through such key measures as a new talent recruitment system. The mode has proved successful in such aspects as improving the ranking of scientific and technological value of hospitals and disciplines, introducing high-level talents, and outputting scientific and technological achievements, supporting by research wards for other departments of the hospital, and improving the efficiency and quality of clinical trials. Such a mode can provide reference for general hospitals in building research hospitals.

Humans ; Enteral Nutrition ; Intubation, Gastrointestinal ; Gastrointestinal Hemorrhage ; Platelet-Rich Plasma

Objective:To investigate the independent predictors for malignancy in colorectal laterally spreading tumors (LSTs) by therapeutic endoscopy.Methods:Data of consecutive patients with colorectal LSTs who underwent endoscopic treatment in Beijing Friendship Hospital between June 2013 and March 2019 were collected for retrospective analysis. Patients′ gender, age, body mass index, smoking history, and endoscopic and histological results were reviewed. Univariate analysis was used to identify the associated factors for malignancy of colorectal LSTs. Factors with statistical significance in univariate analysis were used in multivariate logistic regression to determine the independent predictors.Results:A total of 323 patients with 341 colorectal LSTs were involved in the study. The rate of malignancy was highest in non-granular pseudo depressed (NG-PD) subtype [85.48% (53/62)], followed by granular nodular mixed (G-NM) subtype [76.97% (117/152)]. Both of the above rates were significantly higher than that of granular homogenous (G-H) subtype [29.51% (18/61), P<0.001] and non-granular flat elevated (NG-FE) subtype [24.24% (16/66), P<0.001]. Univariate analysis showed that NG-PD subtype ( P<0.001, OR=18.40, 95% CI: 7.46-45.42), G-NM subtype ( P<0.001, OR=10.45, 95% CI: 5.30-20.58), rectosigmoid location ( P<0.001, OR=2.33, 95% CI: 1.47-3.69) and size ≥2 cm ( P<0.001, OR=2.60, 95% CI: 1.60-4.00) associated with malignancy for colorectal LSTs. In multivariate logistic regression, NG-PD subtype ( P<0.001, OR=17.51, 95% CI: 7.06-43.43), G-NM subtype ( P<0.001, OR=8.25, 95% CI: 4.07-16.73) and size ≥2 cm ( P=0.032, OR=1.80, 95% CI: 1.05-3.08) remained to be independent predictors. Conclusion:LSTs of NG-PD subtype, G-NM subtype or size ≥2 cm are high risk factors of malignancy, in which cases, en bloc resection is required.

Objective:To investigate the risk factors for prolonged procedure time of endoscopic submucosal dissection (ESD) for colorectal laterally spreading tumors (LSTs).Methods:Consecutive patients who underwent ESD for colorectal LSTs at Beijing Digestive Disease Center from June 2013 to March 2019 were retrospectively analyzed. Univariate analysis was used to identify factors associated with prolonged procedure time (≥60 min). Factors with significant difference in univariate analysis were included in multivariate logistic regression to determine the independent risk factors.Results:A total of 201 patients (age 65.05±10.44 years old, 53.73% were males) with 213 LSTs (diameter 2.52±1.67 cm) were included. En bloc resection rate, complete resection rate and curative resection rate were 93.90%, 84.04% and 79.81%, respectively. Intraoperative perforation rate, delayed perforation rate and delayed bleeding rate were 1.88%, 0.94% and 1.41%, respectively. Diameter ≥3 cm ( OR=13.48, P<0.001), granular nodular mixed (G-NM) subtype ( OR=25.28, P=0.002), granular homogenous subtype ( OR=9.00, P=0.045), location of rectosigmoid ( OR=3.08, P=0.002) and positive non-lifting sign ( OR=3.40, P=0.012) were associated with longer procedure time in univariate analysis. In multivariate logistic regression, diameter ≥3 cm ( OR=9.29, P<0.001), G-NM subtype ( OR=8.80, P=0.043) and positive non-lifting sign ( OR=3.43, P=0.043) were independent risk factors for prolonged procedure time. Longer procedure time was associated with lower rates of complete resection (69.56% VS 88.55%, P=0.003) and curative resection (63.64% VS 85.50%, P=0.002), and increased rate of carcinoma (86.96% VS 51.91%, P<0.001). Conclusion:LSTs of size over 3 cm, G-NM subtype or positive non-lifting sign predict prolonged procedure time, which is associated with reduced efficacy of ESD and higher risk of carcinoma.

Objective To evaluate the diagnostic value of endoscopic ultrasonography(EUS)on preoperative invasive depth of early esophageal cancer. Methods A systematic retrieval was performed in PubMed,CNKI and Wangfang databases. Studies on diagnosis of EUS on invasion depth or T1a/T1b stage of early esophageal cancer were retrieved, and related literatures were selected for meta?analysis based on inclusion criteria. The sensitivity, specificity, positive likelihood ratio, negative likelihood ratio and diagnostic advantage were calculated,and the receiver operating characteristic curve was drawn to calculate the area under the curve(AUC).Results A total of 20 articles with 1 336 cases were included in the meta?analysis. The pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnostic odds ratio and AUC of EUS for T1m staging of early esophageal cancer were 0.86(95%CI: 0.83?0.88), 0.81(95%CI: 0.78?0.85), 4.92(95%CI: 3.02?8.00), 0.19(95%CI: 0.14?0.27), 32.54(95%CI:15.52?68.25)and 0.923,respectively. For T1sm staging, these results were 0.81(95%CI: 0.78?0.85), 0.86(95%CI: 0.83?0.88), 5.17(95%CI: 3.66?7.32), 0.20(95%CI: 0.13?0.33), 32.02(95%CI:15.31?66.99)and 0.922, respectively. Conclusion The diagnostic value of EUS is good for early esophageal cancer, and it has a relatively high sensitivity, specificity and AUC for the T1m and T1sm staging.

Objective To observe the effects of percutaneous endoscopic gastrostomy (PEG)on mortality and complications in patients with persistent dysphagia after stroke using a points scoring system for selecting PEG indication.Methods A total of 75 patients were divided into low score group without PEG,high score group without PEG and low score group with PEG (n=25 each).The follow-up period was 18 months,and the differences in complications,mortalities and survival periods among groups were compared.Results The number of times of aspiration pneumonia was (1.36± 1.44) in low score group,(1.96±2.28) in high score group,(0.36±0.64) in low score group with PEG,with statistically significant differences among three groups (H=7.148,P=0.028).No difference in the morbidity of aspiration pneumonia was found between low score group and high score group (P=0.189).The number of times of aspiration pneumonia was decreased in low score groups after PEG versus in low score group without PEG (P=0.030) and in high score group (P＜0.01).The numberof times of gastrointestinal hemorrhage was (0.48± 0.77)in low score group,(0.64± 0.91) in high score group,(0.12±0.33) in low score group with PEG,with statistically significant differences among three groups (H=5.532,P =0.063).No statistically significant difference in gastrointestinal hemorrhage was found between low score groups and low score group after PEG (P=0.430),as well as between low score group and low score group with PEG (P=0.079).The morbidity of gastrointestinal hemorrhage was lower in low score group than in high score group (P=0.012).The survival rate at the observation end was 88.0％ (22/25),52.0％ (13/25) and 92.0％ (23/25) in low score group,high score group and low score group with PEG,respectively,with statistically significant difference among the three groups (x2 =7.906,P =0.001).Kaplan-Meier survival curve showed that the survival period were longer in the low score group with or without PEG than in high score group (P＜0.01),but no statistically significant difference was found between low score groups with or without PEG (P=0.626).Conclusions The reasonable evaluation using a points-scoring system before PEG might predict the prognosis of such patients:the higher score would indicate higher mortality.PEG operation for low score group with better condition could decrease the aspiration pneumonia and decrease gastrointestinal hemorrhage significantly,but could not prolong general survival time and decrease general mortality.

Objective To discuss the technical points and the clinical application of single wire-guided inverted Y-shaped tracheal stent implantation under general anesthesia in treating complex tracheal diseases. Methods During the period from January 2014 to October 2014 at authors’ hospital, a total of 6 patients with complex tracheal diseases received inverted Y-shaped tracheal stent implantation. The diseases included trachea-pleural fistula(n=1), trachea-esophageal fistula(n=2) and complex tracheal stenosis(n=3). Under general anesthesia and guided by DSA, inverted Y-shaped tracheal stent implantation was carried out in all the 6 patients. The results were analyzed. Results A total of 6 Y-shaped tracheal stents were used in the 6 patients, and single wire-guided implantation technique was employed in all procedures. In one case , the right branch of the Y-shaped tracheal stent was placed in the right upper lobe bronchus by mistake , and in the remaining 5 cases the stent implantation was successfully accomplished with single manipulation. Conclusion Under general anesthesia, Y-shaped tracheal stent implantation can effectively obstruct the trachea-pleural fistula and left main bronchus-esophageal fistula, and it can also quickly and significantly relieve the complex airway stenosis located at the tracheal carina region. This treatment is safe and reliable with satisfactory short-term effect. Moreover, single wire-guided manipulation is technically simpler, easier and faster than dual wire-guided manipulation. Therefore, this technique should be recommended in the clinical practice.

Objective To evaluate the clinical utility of SpyGlass single-operator ERCP-guided cholangiopancreatoscopy system for the diagnosis and treatment of bile duct disorders.Methods A total of 9 patients with biliary diseases were treated with SpyGlass single-operator ERCP-guided cholangiopancreatoscopy system.Four patients with large bile duct stones accepted laser lithotripsy,and stones were removed by ERCP.Five patients with indeterminate bile duct stricture accepted cholangioscopy-guided sampling.All patients underwent ENBD,routine blood test,blood amylase test,oral food and water restriction,acid suppression and prophylactic antibiotics.Results SpyGlass was successful in all patients with a manipulating time of 21.2min and total procedure time of 46.2min.Complete stone clearance was achieved in all 4 patients with large biliary stones.Sample quality was adequate in all patients with bile duct stricture with 2 patients diagnosed as having malignant biliary tumor and 3 as inflammatory bile duct stenosis.Post-ERCP complications including mild pancreatitis in 2 patients,and the patients recovered gradually after corresponding treatment.Conclusion ERCP-guided cholangiopancreatoscopy with the SpyGlass system is technically feasible and can be successfully and safely performed in patients with biliary disorders.

Objective To determine the safety and clinical value of secondary ERCP to a failed intubation procedure.Methods A total of 212 patients with difficult intubation during ERCP procedures were enrolled.Patients with failed conventional intubation accepted precut sphincterotomy.The operation stopped after one hour of effort.A secondary selective ERCP was performed at a appropriate time.The operation success rate and complication rate of first ERCP and secondary ERCP were compared.Results The success rate of first ERCP was 67.0％ (142/212),and the total success rate was 90.6％ (192/212).The total success rate is significantly higher than that of first ERCP operation(x2 =35.263,P ＜0.05).The complication rate of first ERCP,secondary ERCP and total complication rate was 8.96％ (19/212),4.29％ (3/70),10.38％ (22/212),respectively.Complication rates of total ERCP and secondary ERCP were not significantly different from the first ERCP (P ＞ 0.05).Conclusion It is safe and effective for patients with failed ERCP intubations after precut to receive a secondary ERCP at a appropriate time.