Risk assessment of variant Creutzfeldt-Jakob disease in corneal transplantation

Purpose: While corneal transplantation is known to have a potential risk of transmission of variant Creutzfeldt-Jacob Disease (vCJD), the magnitude of this risk has not been quantified. Observations: A case report is presented of a 73 year-old man with a penetrating keratoplasty graft from corneal tissue that was recalled after transplantation due to risk of vCJD because it was later discovered that the donor had traveled to the United Kingdom (UK). Probabilities of vCJD transmission were extrapolated using Creutzfeldt-Jacob Disease (CJD) mortality (incidence) rate, all-cause death rate, and rate of recovery for intended transplantation. Conclusions: An overestimate of the risk of transplanting a cornea infected with vCJD in 2018 was 1 in 940,000. The true risk of vCJD transmission would be even lower due to an incomplete infectivity rate. We conclude that the risk of transmission of latent vCJD by corneal transplantation from a donor who traveled to the UK from 1980 to 1996 is exceedingly low

Industrial Data-Driven Processing Framework Combining Process Knowledge for Improved Decision Making—Part 1: Framework Development

Data management systems are increasingly used in industrial processes. However, data collected as part of industrial process operations, such as sensor or measurement instruments data, contain various sources of errors that can hamper process analysis and decision making. The authors propose an operating-regime-based data processing framework for industrial process decision making. The framework was designed to increase the quality and take advantage of available process data use to make informed offline strategic business operation decisions, i.e., environmental, cost and energy analysis, optimization, fault detection, debottlenecking, etc. The approach was synthesized from best practices derived from the available framework and improved upon its predecessor by putting forward the combination of process expertise and data-driven approaches. This systematic and structured approach includes the following stages: (1) scope of the analysis, (2) signal processing, (3) steady-state operating periods detection, (4) data reconciliation and (5) operating regime detection and identification. The proposed framework is applied to the brownstock washing department of a dissolving pulp mill. Over a 5-month period, the process was found to be in steady-state 32% of the time. Twenty (20) distinct operating regimes were identified. Further processing with the help of data reconciliation techniques, principal component analysis and k-means clustering showed that the main drivers explaining the operating regimes are the pulp level in tanks, its density, and the shower wash water flow rate. Additionally, it was concluded that the top four persistently problematic sensors across the steady-state spans that would need to be verified are three flow meters (06FIC137, 06FIC152, and 06FIC433), and one consistency sensor (06NIC423). This information was relayed to process experts contacts at the plant for further investigation

ELEMENT TRIAL: study protocol for a randomized controlled trial on endoscopic ultrasound-guided biliary drainage of first intent with a lumen-apposing metal stent vs. endoscopic retrograde cholangio-pancreatography in the management of malignant distal biliary obstruction

Background & aims: Endoscopic ultrasound guided-biliary drainage (EUS-BD) is a promising alternative to endoscopic retrograde cholangiopancreatography (ERCP); however, its growth has been limited by a lack of multicenter randomized controlled trials (RCT) and dedicated devices. A dedicated EUS-BD lumen- apposing metal stent (LAMS) has recently been developed with the potential to greatly facilitate the technique and safety of the procedure. We aim to compare a first intent approach with EUS-guided choledochoduodenostomy with a dedicated biliary LAMS vs. standard ERCP in the management of malignant distal biliary obstruction. Methods: The ELEMENT trial is a multicenter single-blinded RCT involving 130 patients in nine Canadian centers. Patients with unresectable, locally advanced, or borderline resectable malignant distal biliary obstruction meeting the inclusion and exclusion criteria will be randomized to EUS-choledochoduodenostomy using a LAMS or ERCP with traditional metal stent insertion in a 1:1 proportion in blocks of four. Patients with hilar obstruction, resectable cancer, or benign disease are excluded. The primary endpoint is the rate of stent dysfunction needing re-intervention. Secondary outcomes include technical and clinical success, interruptions in chemotherapy, rate of surgical resection, time to stent dysfunction, and adverse events. Discussion: The ELEMENT trial is designed to assess whether EUS-guided choledochoduodenostomy using a dedicated LAMS is superior to conventional ERCP as a first-line endoscopic drainage approach in malignant distal biliary obstruction, which is an important and timely question that has not been addressed using an RCT study design. Trial registration: Registry name: ClinicalTrials.gov. Registration number: NCT03870386. Date of registration: 03/12/2019.Medicine, Faculty ofOther UBCNon UBCGastroenterology, Division ofMedicine, Department ofReviewedFacult