Prevalence of psychotropic medication and factors associated with antipsychotic treatment in adults with intellectual disabilities: a cross-sectional, epidemiological study in Germany.

BACKGROUND: Mental health services in people with intellectual disabilities (ID) are frequently limited to psychotropic medication (PM), especially antipsychotics. The objectives of this study were to assess the prevalence rates of PM treatment in adults with ID in Germany and to identify factors associated with antipsychotic treatment. METHODS: This study is an epidemiological, cross-sectional study. Sampling was realised by a random selection of service-providing institutions, followed by a random selection of adults with ID within these participating institutions. Interviews were conducted with formal and informal carers of n = 197 adults with ID. Data were analysed using descriptive statistics and risk ratios. RESULTS: The 4-week prevalence rate of PM was 53.8%. Antipsychotics were the most frequent PM (43.7%). Polypharmacy and off-label use were common. Antipsychotic treatment is associated with living in a residential home [relative risk (RR) = 2.99], not working in a sheltered workshop (RR = 1.46), autism spectrum disorder (RR = 1.89), a documented psychiatric diagnosis (RR = 1.61), psychiatric symptomatology (RR = 1.44) and (mild) challenging behaviours (RR = 4.58). CONCLUSIONS: Further efforts are needed to provide adequate mental health care, specifically to improve PM treatment regarding amount, indication and the consideration of non-psychopharmacological treatment options.

Endoscopic mucosal resection (EMR) versus endoscopic submucosal dissection (ESD) for resection of large distal non-pedunculated colorectal adenomas (MATILDA-trial): rationale and design of a multicenter randomized clinical trial.

BACKGROUND: Endoscopic mucosal resection (EMR) is currently the most used technique for resection of large distal colorectal polyps. However, in large lesions EMR can often only be performed in a piecemeal fashion resulting in relatively low radical (R0)-resection rates and high recurrence rates. Endoscopic submucosal dissection (ESD) is a newer procedure that is more difficult resulting in a longer procedural time, but is promising due to the high en-bloc resection rates and the very low recurrence rates. We aim to evaluate the (cost-)effectiveness of ESD against EMR on both short (i.e. 6 months) and long-term (i.e. 36 months). We hypothesize that in the short-run ESD is more time consuming resulting in higher healthcare costs, but is (cost-) effective on the long-term due to lower patients burden, a higher number of R0-resections and lower recurrence rates with less need for repeated procedures. METHODS: This is a multicenter randomized clinical trial in patients with a non-pedunculated polyp larger than 20 mm in the rectum, sigmoid, or descending colon suspected to be an adenoma by means of endoscopic assessment. Primary endpoint is recurrence rate at follow-up colonoscopy at 6 months. Secondary endpoints are R0-resection rate, perceived burden and quality of life, healthcare resources utilization and costs, surgical referral rate, complication rate and recurrence rate at 36 months. Quality-adjusted-life-year (QALY) will be estimated taking an area under the curve approach and using EQ-5D-indexes. Healthcare costs will be calculated by multiplying used healthcare services with unit prices. The cost-effectiveness of ESD against EMR will be expressed as incremental cost-effectiveness ratios (ICER) showing additional costs per recurrence free patient and as ICER showing additional costs per QALY. DISCUSSION: If this trial confirms ESD to be favorable on the long-term, the burden of extra colonoscopies and repeated procedures can be prevented for future patients. TRIAL REGISTRATION: NCT02657044 (Clinicaltrials.gov), registered January 8, 2016.

Endoscopic Resection Without Subsequent Ablation Therapy for Early Barrett's Neoplasia: Endoscopic Findings and Long-Term Mortality.

INTRODUCTION: After endoscopic resection (ER) of neoplasia in Barrett's esophagus (BE), it is recommended to ablate the remaining BE to minimize the risk for metachronous disease. However, we report long-term outcomes for a nationwide cohort of all patients who did not undergo ablation of the remaining BE after ER for early BE neoplasia, due to clinical reasons or performance status. METHODS: Endoscopic therapy for BE neoplasia in the Netherlands is centralized in 8 expert centers with specifically trained endoscopists and pathologists. Uniformity is ensured by a joint protocol and regular group meetings. We report all patients who underwent ER for a neoplastic lesion between 2008 and 2018, without further ablation therapy. Outcomes include progression during endoscopic FU and all-cause mortality. RESULTS: Ninety-four patients were included with mean age 74 (± 10) years. ER was performed for low-grade dysplasia (LGD) (10%), high-grade dysplasia (HGD) (25%), or low-risk esophageal adenocarcinoma (EAC) (65%). No additional ablation was performed for several reasons; in 73 patients (78%), the main argument was expected limited life expectancy. Median C2M5 BE persisted after ER, and during median 21 months (IQR 11-51) with 4 endoscopies per patient, no patient progressed to advanced cancer. Seventeen patients (18%) developed HGD/EAC: all were curatively treated endoscopically. In total, 29/73 patients (40%) with expected limited life expectancy died due to unrelated causes during FU, none of EAC. CONCLUSION: In selected patients, ER monotherapy with endoscopic surveillance of the residual BE is a valid alternative to eradication therapy with ablation.

Preliminary report on the safety and utility of a novel automated mechanical endoscopic tissue resection tool for endoscopic necrosectomy: a case series.

Background and study aims Endoscopic drainage of walled-off necrosis and subsequent endoscopic necrosectomy has been shown to be an effective step-up management strategy in patients with acute necrotizing pancreatitis. One of the limitations of this endoscopic approach however, is the lack of dedicated and effective instruments to remove necrotic tissue. We aimed to evaluate the technical feasibility, safety, and clinical outcome of the EndoRotor, a novel automated mechanical endoscopic tissue resection tool, in patients with necrotizing pancreatitis. Methods Patients with infected necrotizing pancreatitis in need of endoscopic necrosectomy after initial cystogastroscopy, were treated using the EndoRotor. Procedures were performed under conscious or propofol sedation by six experienced endoscopists. Technical feasibility, safety, and clinical outcomes were evaluated and scored. Operator experience was assessed by a short questionnaire. Results Twelve patients with a median age of 60.6 years, underwent a total of 27 procedures for removal of infected pancreatic necrosis using the EndoRotor. Of these, nine patients were treated de novo. Three patients had already undergone unsuccessful endoscopic necrosectomy procedures using conventional tools. The mean size of the walled-off cavities was 117.5 ± 51.9 mm. An average of two procedures (range 1 - 7) per patient was required to achieve complete removal of necrotic tissue with the EndoRotor. No procedure-related adverse events occurred. Endoscopists deemed the device to be easy to use and effective for safe and controlled removal of the necrosis. Conclusions Initial experience with the EndoRotor suggests that this device can safely, rapidly, and effectively remove necrotic tissue in patients with (infected) walled-off pancreatic necrosis.

Screening for head and neck second primary tumors in patients with esophageal squamous cell cancer: A systematic review and meta-analysis.

Background: Esophageal squamous cell carcinomas (ESCCs) are often accompanied by head and neck second primary tumors (HNSPTs). The prognosis of patients with an additional HNSPT is worse compared with patients with only ESCC. Therefore, early detection of HNSPTs may improve the overall outcome of patients with ESCC. The purpose of this study was to investigate the yield of endoscopic screening for HNSPTs in patients with primary ESCC. Methods: We conducted a systematic literature search of all available databases. Studies were included if ESCC patients were endoscopically screened for HNSPT. The primary outcome was the pooled prevalence of HNSPTs. Results: Twelve studies, all performed in Japan, were included in this systematic review with a total of 6483 patients. The pooled prevalence of HNSPTs was 6.7% (95% confidence interval: 4.9-8.4). The overall heterogeneity was high across the studies (I2 = 89.0%, p < 0.001). Most HNSPTs were low stage (85.3%) and located in the hypopharynx (60.3%). The proportion of synchronous (48.2%) and metachronous (51.8%) HNSPTs was comparable. Conclusion: Based on our results, HNSPT screening could be considered in patients with primary ESCC. All studies were performed in Japan; it is therefore not clear whether this consideration applies to the Western world.

Propofol sedation without endotracheal intubation is safe for endoscopic submucosal dissection in the esophagus and stomach.

Background: Endoscopic submucosal dissection (ESD) for early esophageal and stomach cancer is usually performed under general anesthesia. However, propofol sedation without endotracheal intubation has been suggested as a viable alternative. Objective: The objective of this study was to evaluate the safety of propofol sedation without endotracheal intubation during ESD in the upper gastrointestinal tract. Methods: We performed a retrospective cohort study of patients who underwent ESD for upper gastrointestinal tumors with propofol-remifentanil analgosedation in a tertiary referral center in the Netherlands between October 2013 and February 2018. Primary endpoints were the rates of intraprocedural endoscopy- and anesthesia-related complications. Secondary endpoints were the postprocedural complication rates within 30 days and endotracheal intubation conversion rates. Results: Of 88 patients, intraprocedural ESD-related complications occurred in three patients (3.4%). Intraprocedural anesthesia-related complications occurred in two patients (2.3%), one of whom required conversion to endotracheal intubation. Postprocedural ESD-related complications occurred in 14 patients (15.9%), and minor postprocedural complications occurred in two patients (2.3%). Eighty-two (93.2%) patients were discharged within one day after ESD. No patient was readmitted for anesthesia-related complications. Conclusion: Propofol-based sedation without endotracheal intubation is safe for ESD procedures in the esophagus and stomach with low anesthesia-related complication rates and short hospital stay.

A second-generation virtual reality simulator for colonoscopy: validation and initial experience.

BACKGROUND AND STUDY AIMS: Simulators are increasingly used in skills training for physicians; however data on systematic evaluation of the performance of these simulators are scarce compared with those used in aviation. The objectives of this study were to determine the expert validity, the construct validity, and the training value of the novel Olympus simulator as judged by experts. PATIENTS AND METHODS: Participants were novices and experts. Novices had no prior experience in flexible endoscopy; experts had all performed more than 1000 colonoscopies. Participants filled out a questionnaire on their impression of the realism of the colonoscopy exercises performed. These included a dexterity exercise and a virtual colonoscopy. Test parameters used were points acquired in a game, time to reach the cecum, maximum insertion force, and "patient pain." RESULTS: Novices (n = 26) scored a median of 973 points (range--118-1393), experts (n = 23) scored 1212 points (range 89-1375). This difference did not reach significance (P = 0.073). Experts performed virtual colonoscopy significantly faster than novices (220 vs. 780 s, P < 0.001) but used more insertion force (11.8 vs. 11.6 N; P = 0.147). Maximum pain score was higher in the expert group: 86% vs. 73%. (P = 0.018). The realism was graded 6.5 on a 10-point scale. Experts considered the Olympus simulator beneficial for the training of novice endoscopists. CONCLUSIONS: The novel Olympus simulator discriminates excellently between the measured levels of expertise. The prototype offers a good realistic representation of colonoscopy according to experts. Although the software development is continuing, the device can already be implemented in the training program of novice endoscopists.

A single-step sizing and radiofrequency ablation catheter for circumferential ablation of Barrett's esophagus: Results of a pilot study.

BACKGROUND: The 360 Express balloon catheter (360 Express) has the ability to self-adjust to the esophageal lumen, ensuring optimal tissue contact. OBJECTIVE: The objective of this article is to evaluate the efficacy and safety of the 360 Express for radiofrequency ablation (RFA) treatment of Barrett's esophagus (BE). METHODS: BE patients with low-grade dysplasia (LGD), high-grade dysplasia (HGD) or early cancer (EC) were included. Visible lesions were removed by endoscopic resection (ER) prior to RFA. RFA was performed with the 360 Express using the standard ablation regimen (12J/cm2-clean-12J/cm2). Primary outcome: BE regression percentage at three months. Secondary outcomes: procedure time, adverse events, complete eradication of dysplasia (CE-D) and intestinal metaplasia (CE-IM). RESULTS: Thirty patients (median BE C4M6) were included. Eight patients underwent ER prior to RFA. Median BE regression: 90%. Median procedure time: 31 minutes. Adverse events (13%): laceration (n = 1); atrial fibrillation (n = 1); vomiting and dysphagia (n = 1); dysregulated diabetes (n = 1). After subsequent treatment CE-D and CE-IM was achieved in 97% and 87%, respectively. In 10% a stenosis developed during additional treatment requiring a median of one dilation. CONCLUSION: This study shows that circumferential RFA using the 360 Express may shorten procedure time, while maintaining efficacy compared to standard circumferential RFA.

Acquiring basic endoscopy skills by training on the GI Mentor II.

BACKGROUND: Achieving proficiency in flexible endoscopy requires a great amount of practice. Virtual reality (VR) simulators could provide an effective alternative for clinical training. This study aimed to gain insight into the proficiency curve for basic endoscope navigation skills with training on the GI Mentor II. METHODS: For this study, 30 novice endoscopists performed four preset training sessions. In each session, they performed one EndoBubble task and managed multiple VR colonoscopy cases (two in first session and three in subsequent sessions). Virtual reality colonoscopy I-3 was repeatedly performed as the last VR colonoscopy in each session. The assignment for the VR colonoscopies was to visualize the cecum as quickly as possible without causing patient discomfort. Five expert endoscopists also performed the training sessions. Additionally, the performance of the novices was compared with the performance of 20 experienced and 40 expert endoscopists. RESULTS: The novices progressed significantly, particularly in the time required to accomplish the tasks (p < 0.05, Friedman's analysis of variance [ANOVA], p < 0.05, Wilcoxon signed ranks). The experts did not improve significantly, except in the percentage of time the patient was in excessive pain. For all the runs, the performance of the novices differed significantly from that of both the experienced and the expert endoscopists (p < 0.05, Mann-Whitney U). The performance of the novices in the latter runs differed less from those of both the experienced and the expert endoscopists. CONCLUSIONS: The study findings demonstrate that training in both VR colonoscopy and EndoBubble tasks on the GI Mentor II improves the basic endoscope navigation skills of novice endoscopists significantly.

Extensive jejunal diverticulosis in a family, a matter of inheritance?

Diverticulosis of the jejunum is a rare finding (0.06 to 1.3%). Possible complications are bacterial overgrowth, malabsorption, bleeding, mechanical obstruction, volvulus and perforation. At present only one case report on familial jejunal diverticulosis has been published. We describe three patients with jejunal diverticulosis within one family, which might suggest inheritance.

Simulator training in gastrointestinal endoscopy - From basic training to advanced endoscopic procedures.

Simulator-based gastrointestinal endoscopy training has gained acceptance over the last decades and has been extensively studied. Several types of simulators have been validated and it has been demonstrated that the use of simulators in the early training setting accelerates the learning curve in acquiring basic skills. Current GI endoscopy simulators lack the degree of realism that would be necessary to provide training to achieve full competency or to be applicable in certification. Virtual Reality and mechanical simulators are commonly used in basic flexible endoscopy training, whereas ex vivo and in vivo models are used in training the most advanced endoscopic procedures. Validated models for the training of more routine therapeutic interventions like polypectomy, EMR, stenting and haemostasis are lacking or scarce and developments in these areas should be encouraged.

Breast cancer and the role of breast size as a contributory factor.

Several studies have been published on the incidence of breast cancer following augmentation mammaplasty, with very different conclusions. A lower incidence of breast cancer than expected was found in a study conducted by Deapen and Brody in women who had undergone augmentation surgery, and an anticarcinogenic effect of silicone implants has been suggested. Before accepting this conclusion it is important to study the relationship between breast size and the risk of developing breast cancer. It can be assumed that on average, women who have their breasts enlarged have smaller breasts, originally, than other women. Therefore, it seemed possible that breast size might be the predominant factor, and not the silicone implant. To test the hypothesis that women with breast cancer have statistically larger breasts than women who are not found to have breast cancer, a questionnaire was sent to each of 232 women who had undergone surgery for breast cancer; 146 of these questionnaires were returned. Body mass index (BMI) and breast size were compared against the corresponding values in a population-based control group. The results showed no statistical difference between the two groups in BMI or breast size. These findings seem to support the hypothesis that silicone breast implants have some kind of anticarcinogenic effect.