Effect of cap-assisted esophagogastroduodenoscopy on examination of the major duodenal papilla: a noninferior, randomized controlled trial.

BACKGROUND: Cap-assisted esophagogastroduodenoscopy (CA-EGD) using a transparent cap fitted to the tip of the scope has emerged as an alternative method for examination of the major duodenal papilla (MDP). However, it remains unclear whether CA-EGD is noninferior to standard duodenoscopy for MDP examination. The aim of this study was to compare the efficacies of the two methods for complete examination of the MDP. METHODS: This prospective, noninferior, randomized controlled study was conducted at two endoscopy centers. Consecutive patients who underwent endoscopic retrograde cholangiopancreatography were randomized (1:1) to undergo CA-EGD or standard duodenoscopy for MDP examination. The primary outcome was complete examination of the MDP, defined as visualization of the upper end, opening, and lower end of the papilla. Secondary outcomes included endoscopic findings and the time taken for the MDP examination. RESULTS: The study was terminated for futility after the interim analysis. A total of 171 patients were randomly allocated to CA-EGD (n = 85) or standard duodenoscopy (n = 86). The baseline characteristics were comparable between the two groups. Complete examination of the MDP was achieved in 58/85 patients (68.2 %) in the CA-EGD group and in 74/86 (86.0 %) in standard duodenoscopy group. The difference in proportions was - 17.81 percentage points (95 % confidence interval [CI] -28.14 to -7.48) by intention-to-treat analysis and - 18.22 percentage points (95 %CI -28.34 to -8.10) by per-protocol analysis, both of which were significantly lower than the noninferiority margin of -5 %, and therefore the noninferiority of CA-EGD could not be confirmed. Examination time was significantly longer with CA-EGD (69.5 [SD 46.4] vs. 33.0 [SD 28.9] seconds; P < 0.001). CONCLUSIONS: Although complete examination of the MDP can be achieved by CA-EGD in most patients, it could not replace duodenoscopy as the standard method for examination of the MDP.

Appropriate time for selective biliary cannulation by trainees during ERCP--a randomized trial.

BACKGROUND AND STUDY AIM: The allocation of sufficient time for trainees to attempt cannulation is necessary for learning and to ensure success with endoscopic retrograde cholangiopancreatography (ERCP) training. However, it is important to balance the benefit to trainee practice against the potential risks to patients. The appropriate time for attempted cannulation by trainees remains unclear. PATIENTS AND METHODS: Three different time limits (5, 10, 15 minutes) were set for cannulation attempts made by four trainees in patients with native papilla undergoing ERCP. Patients were randomly assigned to the 5-, 10-, or 15-minute groups in a 1:1:1 ratio. Rectal indomethacin was used in high-risk patients. The primary outcome was successful cannulation within the allocated time. Secondary outcomes included performance scores, overall success rate, and post-ERCP pancreatitis (PEP). RESULTS: A total of 256 patients were randomly assigned to the 5-minute (n = 84), 10-minute (n = 86), or 15-minute (n = 86) groups. Patients' baseline characteristics were comparable. Success rates for selective bile duct cannulation by trainees were 43.8 %, 75.0 %, and 71.8 % in the 5-, 10-, and 15-minute groups, respectively (P < 0.001). Trainees' self-reported performance scores and video assessment by an independent reviewer were comparable between the 10- and 15-minute groups, which were higher than the 5-minute group (both P  < 0.001). Trainers took over the cannulation procedure when trainees did not succeed within the allocated time. There was no significant difference in the overall success rates in cannulation between the three groups. No differences were noted in the use of rectal indomethacin and overall complication rates. Four patients in each group developed PEP (P = 0.996). CONCLUSION: A time of 10 minutes was considered to be appropriate for trainees to attempt cannulation, with acceptable cannulation success rates and complications. TRIAL REGISTRATION: ClinicalTrials.gov number (NCT01851226).

Difficult colonoscopy score identifies the difficult patients undergoing unsedated colonoscopy.

BACKGROUND: Many factors have been found to affect the difficulty of colonoscope insertion, such as age, gender, body mass index (BMI), history of abdominal surgery and operator etc. However, a scoring system may be more useful to predict the difficulty during colonoscopy. METHODS: The individual and procedure-related data of 616 patients undergoing colonoscopy were prospectively collected from December 2013 through February 2014 in Xijing Hospital of Digestive Diseases. Cox regression analysis was used to identify high-risk factors associated with difficulty of colonoscopy. A predicting model with the difficult colonoscopy score (DCS) was developed. RESULTS: Total cecum intubation rate was 98.9% (609/616). Advanced age, lower BMI, inexperienced operator and fair or poor sleep quality were identified as independent factors of prolonged insertion time (all p < 0.05), which were used to develop the DCS. Based on the score, patients could be divided into high-risk and low-risk groups with distinct incomplete rates within 10 min (42.0% vs. 16.5%, p < 0.001). Compared with those with DCS ≤ 1, patients with DCS > 1 had increased insertion time (10.6 ± 0.7 min vs. 6.9 ± 0.2 min, p < 0.001) and pain score (1.9 ± 1.5 vs. 1.4 ± 1.4, p = 0.002). More abdominal compression (36.9% vs. 16.8%, p < 0.001) and position change (51.4% vs. 22.6%, p < 0.001) were needed in this group of patients. CONCLUSION: Patients with DCS > 1 had longer insertion time, higher pain score and needed more abdominal compression and position changes. DCS was useful for predicting the difficulty of colonoscope intubation. (ClinicalTrials.gov NCT02105025 05/05/2014).

[Key Technology and Quantity Control of Wearable Medical Devices].

In recent years, because the wearable medical devices can indicate the health monitoring index of blood sugar, blood pressure, heart rate, oxygen content, temperature, respiration of the human body anytime and anywhere, can also be used for the treatment of various diseases, accompanied by the development of large data, which will bring a subversive revolution for the medical device industry. This paper introduces the development of wearable devices, key technical index of main products, and to make a preliminary study on its quantity control.

Thermal analysis in the rat glioma model during directly multipoint injection hyperthermia incorporating magnetic nanoparticles.

Hyperthermia incorporating magnetic nanoparticles (MNPs) is a hopeful therapy to cancers and steps into clinical tests at present. However, the clinical plan of MNPs deposition in tumors, especially applied for directly multipoint injection hyperthermia (DMIH), and the information of temperature rise in tumors by DMIH is lack of studied. In this paper, we mainly discussed thermal distributions induced by MNPs in the rat brain tumors during DMIH. Due to limited experimental measurement for detecting thermal dose of tumors, and in order to acquire optimized results of temperature distributions clinically needed, we designed the thermal model in which three types of MNPs injection for hyperthermia treatments were simulated. The simulated results showed that MNPs injection plan played an important role in determining thermal distribution, as well as the overall dose of MNPs injected. We found that as injected points enhanced, the difference of temperature in the whole tumor volume decreased. Moreover, from temperature detecting data by Fiber Optic Temperature Sensors (FOTSs) in glioma bearing rats during MNPs hyperthermia, we found the temperature errors by FOTSs reduced as the number of points injected enhanced. Finally, the results showed that the simulations are preferable and the optimized plans of the numbers and spatial positions of MNPs points injected are essential during direct injection hyperthermia.

A novel intubation discomfort score to predict painful unsedated colonoscopy.

ABSTRACT: Pain during colonoscopy is a critical quality indicator and often a limiting factor for unsedated colonoscopy. This study aimed to identify factors associated with pain during colonoscopy and establish a model for predicting a painful colonoscopy.Patients aged 18 to 80 who underwent unsedated colonoscopy were prospectively enrolled in 2 tertiary endoscopic centers in China. The primary outcome was the rate of painful colonoscopy and then we identify high-risk factors associated with painful colonoscopy. A prediction model with an intubation discomfort score (IDS) was developed and validated.Totally 607 patients participated in this study, including 345 in the training cohort and 262 in the validation cohort. Body mass index (BMI) of <18.5 kg/m2 (OR 2.18, 95% CI: 1.09-4.37), constipation (OR 2.45, 95% CI: 1.25-4.80), and anticipating moderate or severe pain (OR 2.06, 95% CI: 1.12-3.79) were identified as independent predictive factors for painful colonoscopy and used to develop the IDS (all P < .05). Patients with IDS ≥1 had increased insertion time [9.32(6.2-13.7)] minutes vs 6.87(5.1-10.4) minutes, P = .038) and decreased cecal intubation rate (96.0% vs 99.6%, P = .044). Abdominal compression (48.4% vs 19.9%, P < .001) and position change (59.7% vs 32.1%, P < .001) were more frequently required in the group of patients with IDS ≥1. These results were externally validated in a validation cohort.The intubation discomfort score developed in this study was useful for predicting pain during colonoscopy, with IDS ≥1 indicating painful colonoscopy.

Effect of water exchange method on adenoma miss rate of patients undergoing selective polypectomy: A randomized controlled trial.

BACKGROUND: Adenomas may be missed in up to 40% of screening colonoscopies. Although the water exchange (WE) method can improve ADR, as shown in several RCTs, it remains uncertain whether it can increase the detection of missing adenomas compared with standard air-insufflated (AI) colonoscopy. METHODS: Patients aged 18-80 years who underwent selective polypectomy were randomly allocated to the WE or AI group. The primary endpoint was the adenoma miss rate (AMR), defined as the number of patients with one or more additional adenomas during the polypectomy procedure divided by the total number of patients in each group. RESULTS: A total of 450 patients were enrolled, with 225 in each group. The overall AMRs were 45.8% (103/225) in the WE group and 35.6% (80/225) in the AI group (p = 0.035). More patients in the WE group had at least one missed adenoma in the proximal colon (38.2% vs 24.4%, p = 0.002). The adenoma-level miss rate was also higher in the WE group than in the AI group (35.1% vs 29.0%, p = 0.036). Subgroup analysis showed that patients in the WE group had more missed adenomas located in the proximal colon or with flat shapes. CONCLUSIONS: This study confirmed that substantial adenomas were missed in patients undergoing selective polypectomy. The WE method significantly improved the detection of missed adenomas, especially those located in the proximal colon or with flat shapes. (ClnicalTrials.gov number: NCT02880748).

Adaptive Admittance Control for an Ankle Exoskeleton Using an EMG-Driven Musculoskeletal Model.

Various rehabilitation robots have been employed to recover the motor function of stroke patients. To improve the effect of rehabilitation, robots should promote patient participation and provide compliant assistance. This paper proposes an adaptive admittance control scheme (AACS) consisting of an admittance filter, inner position controller, and electromyography (EMG)-driven musculoskeletal model (EDMM). The admittance filter generates the subject's intended motion according to the joint torque estimated by the EDMM. The inner position controller tracks the intended motion, and its parameters are adjusted according to the estimated joint stiffness. Eight healthy subjects were instructed to wear the ankle exoskeleton robot, and they completed a series of sinusoidal tracking tasks involving ankle dorsiflexion and plantarflexion. The robot was controlled by the AACS and a non-adaptive admittance control scheme (NAACS) at four fixed parameter levels. The tracking performance was evaluated using the jerk value, position error, interaction torque, and EMG levels of the tibialis anterior (TA) and gastrocnemius (GAS). For the NAACS, the jerk value and position error increased with the parameter levels, and the interaction torque and EMG levels of the TA tended to decrease. In contrast, the AACS could maintain a moderate jerk value, position error, interaction torque, and TA EMG level. These results demonstrate that the AACS achieves a good tradeoff between accurate tracking and compliant assistance because it can produce a real-time response to stiffness changes in the ankle joint. The AACS can alleviate the conflict between accurate tracking and compliant assistance and has potential for application in robot-assisted rehabilitation.

Risk Factors for Post-ERCP Pancreatitis in High-Risk Patients Receiving Post-procedure Rectal Indomethacin.

BACKGROUND: Post-ERCP pancreatitis (PEP) is the most common adverse event of ERCP. Rectal indomethacin has been widely administered to decrease the incidence of PEP in high-risk patients. However, it cannot completely prevent the occurrence of PEP. The purpose of the study was to evaluate the risk factors for PEP in high-risk patients receiving post-ERCP indomethacin. METHODS: From June 2012 to July 2015, patients undergoing ERCP and at high risk for PEP in three tertiary hospitals in China were enrolled. All patients received indomethacin after the procedure. Patient-related and procedure-related risk factors for PEP were collected. Logistic regression analysis was used to investigate the risk factors. RESULTS: Seven hundred ninety patients at high risk for PEP received post-ERCP indomethacin. The incidence of overall PEP and moderate-to-severe PEP was 8.0 and 1.5%, respectively. In multivariate analysis, suspected sphincter of Oddi dysfunction (SOD) (OR 2.73; 95%CI 1.38-5.43; p = 0.004), the presence of hilar obstruction (OR 4.53; 95%CI 1.60-12.81; p = 0.004), number of cannulation attempts ≥ 13 (OR 2.00; 95%CI 1.07-3.77; p = 0.030), inadvertent pancreatic duct (PD) cannulation ≥ 1 (OR 2.26; 95%CI 1.04-4.90; p = 0.040), and pancreatic contrast injections ≥ 1 (OR 2.30; 95%CI 1.02-5.23; p = 0.046) were high risk factors for overall PEP. For moderate-to-severe PEP, suspected SOD (OR 4.67; 1.19-18.35; p = 0.027), the presence of hilar obstruction (OR 7.95; 1.39-44.97; p = 0.010), and more cannulation attempts (OR 3.71; 1.09-12.65; p = 0.036) were three independent risk factors. CONCLUSIONS: A substantial number of high-risk patients had PEP even receiving post-ERCP rectal indomethacin. The independent risk factors included suspected SOD, hilar stricture, more cannulation attempts, inadvertent PD cannulation, and PD contrast injections. TRIAL REGISTRATION: NCT02709421.

Activities in a social networking-based discussion group by endoscopic retrograde cholangiopancreatography doctors.

BACKGROUND: Online social networking is increasingly being used among medical practitioners. However, few studies have evaluated its use in therapeutic endoscopy. Here, we aimed to analyze the shared topics and activities of a group of endoscopic retrograde cholangiopancreatography (ERCP) doctors in a social networking-based endoscopic retrograde cholangiopancreatography discussion group (EDG). MATERIALS AND METHODS: Six ERCP trainers working in Xijing Hospital and 48 graduated endoscopists who had finished ERCP training in the same hospital were invited to join in EDG. All group members were informed not to divulge any private information of patients when using EDG. The activities of group members on EDG were retrospectively extracted. The individual data of the graduated endoscopists were collected by a questionnaire. RESULTS: From June 2014 to May 2015, 6924 messages were posted on EDG, half of which were ERCP related. In total, 214 ERCP-related topics were shared, which could be categorized into three types: sharing experience/cases (52.3%), asking questions (38.3%), and sharing literatures/advances (9.3%). Among the 48 graduated endoscopists, 21 had a low case volume of less than 50 per year and 27 had a high volume case volume of 50 or more. High-volume graduated endoscopists posted more ERCP-related messages (P=0.008) and shared more discussion topics (P=0.003) compared with low-volume graduated endoscopists. A survey showed that EDG was useful for graduated endoscopists in ERCP performance and management of post-ERCP complications, etc. CONCLUSION: A wide range of ERCP-related topics were shared on the social networking-based EDG. The ERCP-related behaviors on EDG were more active in graduated endoscopists with an ERCP case volume of more than 50 per year.