Percutaneous transhepatic or endoscopic ultrasound-guided biliary drainage in malignant distal bile duct obstruction using a self-expanding metal stent: Study protocol for a prospective European multicenter trial (PUMa trial)

Background Endoscopic ultrasound-guided biliary drainage (EUS-BD) was associated with better clinical success and a lower rate of adverse events (AEs) than fluoroscopy-guided percutaneous transhepatic biliary drainage (PTBD) in recent single center studies with mainly retrospective design and small case numbers (< 50). The aim of this prospective European multicenter study is to compare both drainage procedures using ultrasound-guidance and primary metal stent implantation in patients with malignant distal bile duct obstruction (PUMa Trial). Methods The study is designed as a non-randomized, controlled, parallel group, non-inferiority trial. Each of the 16 study centers performs the procedure with the best local expertise (PTBD or EUS-BD). In PTBD, bile duct access is performed by ultrasound guidance. EUS-BD is performed as an endoscopic ultrasound (EUS)-guided hepaticogastrostomy (EUS-HGS), EUS-guided choledochoduodenostomy (EUS-CDS) or EUS-guided antegrade stenting (EUS-AGS). Insertion of a metal stent is intended in both procedures in the first session. Primary end point is technical success. Secondary end points are clinical success, duration pf procedure, AEs graded by severity, length of hospital stay, re-intervention rate and survival within 6 months. The target case number is 212 patients (12 calculated dropouts included). Discussion This study might help to clarify whether PTBD is non-inferior to EUS-BD concerning technical success, and whether one of both interventions is superior in terms of efficacy and safety in one or more secondary endpoints. Randomization is not provided as both procedures are rarely used after failed endoscopic biliary drainage and study centers usually prefer one of both procedures that they can perform best

Training and education of young physicians and engineers in the field of endoscopy and laparoscopy – a review of Germany-wide joint cooperation and training possibilities

Introduction: Application-related (hands-on) training and instruction is an essential component in the advanced education of physicians in residency. To teach and train required endoscopic examinations and interventions in a standardized manner, courses are offered by various societies. Within these courses the assistant endoscopists learn and train how to use the technical equipment and how to perform the examinations and related interventions. Similarly, for graduate biomedical engineering students with a job- or research-related interest in the field of endoand laparoscopy, an early involvement and practical introduction to the instrumentation and techniques - if possible already during their studies - can generate a fundamental understanding of the technical requirements as well needs of the physicians. Objective: As various such (hands-on) training-courses for flexible and rigid endoscopy specifically addressing young physicians, surgeons as well as engineers are offered by numerous institutes, this contribution tries do provide a structured overview on/over these possibilities. Material: Known cross-institutional courses in the field of endo- and laparoscopy currently offered in Germany in cooperation of physicians and engineers are listed and briefly described. Results: A total of n = 4 crossinstitutional courses for the introduction and training in flexible and rigid endoscopy have been identified. Discussion: The cross-institutional courses for physicians and technicians in the field of endo- and laparoscopy presented serve to provide a better understanding of the subject matter and the field of either discipline. Questions that arise in the field of endoscopy from physicians can be addressed at an early stage and, if necessary, worked on with little effort. Ideas for new instruments and even new interventions can arise and be pursued through an intensive exchange between technicians and physicians. Collaborations are established on a local basis which will foster national activities in this field and which allow to develop competencies relevant for the industrial sector of medical engineering