Success rates of fixation techniques on prevention of esophageal stent migration: a systematic review and meta-analysis.

BACKGROUND: Esophageal stenting is an important intervention for managing malignant and benign dysphagia, with stent migration representing a common drawback. This systematic review with meta-analysis aimed to assess the benefit of stent fixation over nonfixation. METHODS: A systematic search was performed in MEDLINE, Cochrane, Scopus, and ClinicalTrials.gov databases until January 2023 for comparative studies evaluating the migration rates of esophageal stents with versus without (control) fixation. The primary outcome was migration rate. Secondary outcomes included adverse event rate. A subgroup analysis stratified the results based on different fixation techniques: suturing, over-the-scope (OTS) clipping, and through-the-scope (TTS) clipping. Meta-analysis was based on a random effects model and the results were reported as odds ratios (ORs) with 95 %CIs. RESULTS: 10 studies (1014 patients) were included. The rate of stent migration was significantly lower after fixation (OR 0.20, 95 %CI 0.11-0.37; I2  = 59 %, P = 0.01). The adverse event rate was similar between fixation and control groups (OR 0.65, 95 %CI 0.28-1.52; I2  = 55 %, P = 0.06). In the subgroup analysis, all fixation techniques remained superior to nonfixation of stents (suturing OR 0.23, 95 %CI 0.10-0.53; OTS clips OR 0.31, 95 %CI 0.17-0.58; TTS clips OR 0.10, 95 %CI 0.03-0.38); however, only the OTS and TTS clip groups achieved nonsignificant heterogeneity (I2  = 0 %, P = 0.67 and P = 0.73, respectively). No difference between techniques was recorded for migration rates. CONCLUSION: Esophageal stent fixation was associated with significantly lower migration rates compared with nonfixation of stents, regardless of fixation technique and stenting indication.

The safety and efficacy of endoscopic approaches for the management of Zenker's diverticulum: a multicentre retrospective study.

INTRODUCTION: Minimally invasive endoscopic options are safe and effective alternatives to surgery for the treatment of symptomatic Zenker's diverticulum (ZD). However, there is no consensus on the gold-standard approach. We compared the safety and efficacy of Zenker's peroral endoscopic myotomy (Z-POEM), flexible diverticulotomy (FD), and rigid diverticulotomy (RD) for the management of ZD. METHODS: Patients undergoing treatment for ZD at three UK tertiary referral centres were identified and analysed between 2013 and 2023. Patient demographics, procedural details, clinical success, and 30-day adverse events (AE) were recorded. The primary outcomes were technical and clinical success defined as a fall in Dakkak and Bennett dysphagia score to ≤ 1 without re-intervention. RESULTS: There was no difference in baseline characteristics amongst 126 patients undergoing intervention (50 RD, 31 FD, 45 Z-POEM). Technical success for RD, FD, and Z-POEM was 80%, 100%, and 100%, respectively (p < 0.001). Over a mean follow-up of 11.0 months (95% CI 8.2-13.9), clinical success amongst those treated was 85.3% (RD), 74.1% (FD), and 83.7% (Z-POEM; p = 0.48) with recurrence in 17.2% (RD), 20.0% (FD), and 8.3% (Z-POEM; p = 0.50). AEs were equivalent between groups (p = 0.98). During this time, 11 patients underwent surgical myotomy with low clinical success (36.4%) and high morbidity. CONCLUSION: Endoscopic options for the treatment of ZD show equivalent rates of success, but failed RD often led to open myotomy with worse outcomes. Flexible endoscopic modalities are both safe and highly effective treatments that may be considered first-line in experienced centres and should be offered before surgery.

UK and Ireland Joint Advisory Group (JAG) consensus statements for training and certification in diagnostic endoscopic ultrasound (EUS).

BACKGROUND AND AIMS: International endoscopy societies vary in their approach for credentialing individuals in endoscopic ultrasound (EUS) to enable independent practice; however, there is no consensus in this or its implementation. In 2019, the Joint Advisory Group on GI Endoscopy (JAG) commissioned a working group to examine the evidence relating to this process for EUS. The aim of this was to develop evidence-based recommendations for EUS training and certification in the UK. METHODS: Under the oversight of the JAG quality assurance team, a modified Delphi process was conducted which included major stakeholders from the UK and Ireland. A formal literature review was made, initial questions for study were proposed and recommendations for training and certification in EUS were formulated after a rigorous assessment using the Grading of Recommendation Assessment, Development and Evaluation tool and subjected to electronic voting to identify accepted statements. These were peer reviewed by JAG and relevant stakeholder societies before consensus on the final EUS certification pathway was achieved. RESULTS: 39 initial questions were proposed of which 33 were deemed worthy of assessment and finally formed the key recommendations. The statements covered four key domains, such as: definition of competence (13 statements), acquisition of competence (10), assessment of competence (5) and postcertification mentorship (5). Key recommendations include: (1) minimum of 250 hands-on cases before an assessment for competency can be made, (2) attendance at the JAG basic EUS course, (3) completing a minimum of one formative direct observation of procedural skills (DOPS) every 10 cases to allow the learning curve in EUS training to be adequately studied, (4) competent performance in summative DOPS assessments and (5) a period of mentorship over a 12-month period is recommended as minimum to support and mentor new service providers. CONCLUSIONS: An evidence-based certification pathway has been commissioned by JAG to support and quality assure EUS training. This will form the basis to improve quality of training and safety standards in EUS in the UK and Ireland.

Endoscopic ultrasound guided gastrojejunostomy in the treatment of gastric outlet obstruction: multi-centre experience from the United Kingdom.

BACKGROUND: Endoscopic ultrasound guided gastrojejunostomy (EUS-GJ) with lumen apposing metal stents has recently emerged as a viable option, as an alternative to surgical gastrojejunostomy and endoscopic enteral stenting, for managing gastric outlet obstruction (GOO). We aim to perform a retrospective analysis of the efficacy, safety and outcomes of EUS-GJ performed at three tertiary institutions in the United Kingdom. METHODS: Consecutive patients who underwent EUS-GJ between August 2018 and March 2021 were identified from a prospectively maintained database. Data were obtained from interrogation of electronic health records. RESULTS: Twenty five patients (15 males) with a median age of 63 years old (range 29-80) were included for analysis. 88% (22/25) of patients had GOO due to underlying malignant disease. All patients were deemed surgically inoperable or at high surgical risk. Both technical and clinical success were achieved in 92% (23/25) of patients. There was an improvement in the mean Gastric Outlet Obstruction Scoring System scores following a technically successful EUS-GJ (2.52 vs 0.68, p < 0.01). Adverse events occurred in 2/25 patients (8%), both due to stent maldeployment necessitating endoscopic closure of the gastric defect with clips. Long-term follow-up data were available for 21 of 23 patients and the re-intervention rate was 4.8% (1/21) over a median follow-up period of 162 (range 5-474) days. CONCLUSION: EUS-GJ in carefully selected patients is an effective and safe procedure when performed by experienced endoscopists.

Changes in UK medical trainees' perceptions of workplace-based assessments across 10 years: results from two cross-sectional studies.

OBJECTIVES: Workplace-based assessments (WPBAs) have become embedded in the training and assessment of UK medical trainees since the onset of the 21st century. When first introduced WPBA required a significant adjustment in both trainees' and educators' training behaviour, and was met with scepticism in some quarters. In this study, we aimed to evaluate how trainees' perceptions of WPBAs have evolved over a 10-year period, as experience with them has increased. DESIGN: Two online questionnaires were constructed and distributed to UK trainees. The first was distributed in 2008, the second in 2018. Questions related to trainees' perception of WPBAs as a learning process and as a reflection of their competence. SETTING AND PARTICIPANTS: All UK medical trainees were eligible to respond. In 2008, 482 trainees from 96 hospitals completed the questionnaire. In 2018, 356 trainees from 103 hospitals completed the questionnaire. MAIN OUTCOME MEASURES: Data were analysed both quantitatively and qualitatively. A comparison between the numbers of each WPBA modality completed in 2008 and 2018 was assessed using chi-squared test. Comparisons of Likert scale values between 2008 and 2018 were assessed using unpaired t-test. Thematic analysis was carried out on free-text answers. RESULTS: The number of forms completed per participant increased significantly from 2008 to 2018. In 2008, forms were most commonly completed immediately after a learning observation (34%). In 2018, forms were most commonly completed between 1 week and 1 month after observation (58%). In 2018, significantly fewer WPBAs were followed by an educational/beneficial discussion in comparison to 2008 data. The most common free-text theme in the 2008 data set was 'supervisor issues' whereas in 2018 the most commonly noted theme was 'limited educational benefit'. CONCLUSIONS: Our study suggests trainees' perspectives of WPBAs have not changed in the 10 years since implementation. Trainees do not perceive WPBA as an accurate reflection of their competency but instead as a 'tick-box' bureaucratic exercise to enable career progression. Development of educator training and trainer and trainee job-planning is required to ensure that WPBAs are genuinely educational activities that offer an accurate reflection of trainees' medical competence.

Antibiotic resistance profiles and population structure of disease-associated Staphylococcus aureus infecting patients in Fort Portal Regional Referral Hospital, Western Uganda.

Tackling antimicrobial resistance (AMR) is particularly challenging in low-resource settings such as Fort Portal Regional Referral Hospital (FPRRH) in Western Uganda. Specific knowledge of local AMR epidemiology is required to inform evidence-based improvement of antibiotic stewardship measures in the hospital. To address this, we combined existing antimicrobial susceptibility testing (AST) from FPRRH, with whole genome sequencing (WGS) of 41 Staphylococcus aureus isolates (2017-2019). AST revealed 73 % (30 of 41) of isolates were resistant to one or more antibiotics and 29 % (12 of 41) were multi-drug resistant (MDR). Resistance phenotypes were largely explained by the presence of antibiotic resistance genes in WGS data. Five isolates were methicillin-resistant S. aureus (MRSA) and MDR. Although all isolates were susceptible to clindamycin, a 24 % carriage of erm genes suggests potential for rapid development of resistance. We inferred a population structure for the S. aureus isolates by comparing their core genomes. Twenty isolates formed a tight cluster corresponding to multilocus sequence typing clonal complex (CC) 152, a CC found to be particularly prevalent in northern Africa. The frequency of genes associated with methicillin, chloramphenicol and ciprofloxacin resistance were significantly lower among CC152 strains than non-CC152 strains; thus, in keeping with previous work, we find that CC152 is almost exclusively methicillin-sensitive S. aureus (MSSA). Also, in agreement with other studies, we observed that the occurrence of Panton-Valentine leukocidin toxin-encoding genes was significantly higher among CC152 strains than non-CC152 strains. However, we also observed that the coagulase gene was over-represented in this CC, further defining the virulence strategy of this important pathogen. By generating detailed information about the epidemiology of circulating S. aureus and their antibiotic susceptibility, our study has provided, for the first time, data on which evidence-based infection and AMR interventions at FPRRH can be based.

Utility of palliative EUS-guided biliary drainage using lumen-apposing metal stents: a prospective multicenter feasibility study (with video).

BACKGROUND AND AIMS: Biliary drainage with ERCP is successful in only 80% to 90% of cases of extrahepatic cholangiocarcinoma and pancreatic cancer. We present the results of a multicenter prospective study assessing the safety, feasibility, and quality of life of patients after EUS-guided biliary drainage (EUS-BD) with lumen-apposing metal stents after failed ERCP. METHODS: All consecutive adults with a dilated common bile duct (CBD) ≥14 mm secondary to inoperable malignant distal CBD stricture and failed ERCP biliary drainage were screened and recruited from 3 tertiary UK centers. Technical success of EUS-BD using lumen-apposing metal stents was the primary endpoint. Improvement in serum bilirubin level, 30-day mortality, procedure-related adverse events, and quality of life were secondary endpoints. Improvement in quality of life was measured using a validated questionnaire (EORTC QLQ-BIL21). RESULTS: Twenty patients were included in the analysis. EUS-BD was technically successful in all patients and the clinical success rate was 95% (19 of 20) at day 7 (>50% reduction in bilirubin level) and 92.3% (12 of 13) at day 30 (bilirubin <50 µmol/L). There were significant improvements in overall quality of life score (49 vs 42, P = .03) at day 30. All-cause 30-day mortality was 20% and the moderate adverse event rate was 10% (1 cholangitis and 1 stent migration). CONCLUSION: EUS-BD has acceptable technical success and safety as a second-line palliative treatment for inoperable malignant distal CBD strictures. Randomized controlled studies comparing EUS-BD with percutaneous transhepatic biliary drainage are needed to determine their effectiveness in clinical practice. (ISCRTN registration number: ISRCTN13196704.).

Curriculum for ERCP and endoscopic ultrasound training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

The European Society of Gastrointestinal Endoscopy (ESGE) has recognized the need to formalize and enhance training in endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS). This manuscript represents the outcome of a formal Delphi process resulting in an official Position Statement of the ESGE and provides a framework to develop and maintain skills in ERCP and EUS. This curriculum is set out in terms of the prerequisites prior to training; recommended steps of training to a defined syllabus; the quality of training; and how competence should be defined and evidenced before independent practice. 1: Trainees should be competent in gastroscopy prior to commencing training. Formal training courses and the use of simulation in training are recommended. 2: Trainees should keep a contemporaneous logbook of their procedures, including key performance indicators and the degree of independence. Structured formative assessment is encouraged to enhance feedback. There should be a summative assessment process prior to commencing independent practice to ensure there is robust evidence of competence. This evidence should include a review of a trainee's procedure volume and current performance measures. A period of mentoring is strongly recommended in the early stages of independent practice. 3: Specifically for ERCP, all trainees should be competent up to Schutz level 2 complexity (management of distal biliary strictures and stones > 10 mm), with advanced ERCP requiring a further period of training. Prior to independent practice, ESGE recommends that a trainee can evidence a procedure volume of > 300 cases, a native papilla cannulation rate of ≥ 80 % (90 % after a period of mentored independent practice), complete stones clearance of ≥ 85 %, and successful stenting of distal biliary strictures of ≥ 90 % (90 % and 95 % respectively after a mentored period of independent practice). 4: The progression of EUS training and competence attainment should start from diagnostic EUS and then proceed to basic therapeutic EUS, and finally to advanced therapeutic EUS. Before independent practice, ESGE recommends that a trainee can evidence a procedure volume of > 250 cases (75 fine-needle aspirations/biopsies [FNA/FNBs]), satisfactory visualization of key anatomical landmarks in ≥ 90 % of cases, and an FNA/FNB accuracy rate of ≥ 85 %. ESGE recognizes the often inadequate quality of the evidence and the need for further studies pertaining to training in advanced endoscopy, particularly in relation to therapeutic EUS.

CCAR1 and CCAR2 as gene chameleons with antagonistic duality: Preclinical, human translational, and mechanistic basis.

Cell Cycle and Apoptosis Regulator 1 (CCAR1) and Cell Cycle and Apoptosis Regulator 2 (CCAR2) have emerged as key players in physiology and pathophysiology, with critical roles in the DNA damage response, nuclear receptor function, and Wnt signaling, among other activities. Contradictory reports exist on the functional duality of CCAR1 and CCAR2 as either tumor promoters or suppressors, suggesting that CCAR1 and CCAR2 have the hallmarks of gene chameleons. We review herein the mechanistic, preclinical, and human translational findings for CCAR1 and CCAR2, based on available RNA and protein expression data from human studies, The Cancer Genome Atlas (TCGA) data mining, gene knockout mouse models, and cell-based assays. Multiple factors contribute to the divergent activities of CCAR1 and CCAR2, including tissue type, mutation/genetic background, protein-protein interactions, dynamic regulation via posttranslational modifications, and alternative RNA splicing. An array of protein partners interact with CCAR1 and CCAR2 in the context of tumor promotion and suppression, including ß-catenin, androgen receptor, p21Cip1/Waf1, tumor protein p53 (p53), sirtuin 1, and histone deacetylase 3. Genetic changes frequently found in cancer, such as TP53 mutation, also serve as critical determinants of survival outcomes in cancer patients. This review seeks to provide the impetus for further investigation into CCAR1 and CCAR2 as potential master regulators of metabolism, aging, and cancer.

Colonoscopy Direct Observation of Procedural Skills Assessment Tool for Evaluating Competency Development During Training.

INTRODUCTION: Formative colonoscopy direct observation of procedural skills (DOPS) assessments were updated in 2016 and incorporated into UK training but lack validity evidence. We aimed to appraise the validity of DOPS assessments, benchmark performance, and evaluate competency development during training in diagnostic colonoscopy. METHODS: This prospective national study identified colonoscopy DOPS submitted over an 18-month period to the UK training e-portfolio. Generalizability analyses were conducted to evaluate internal structure validity and reliability. Benchmarking was performed using receiver operator characteristic analyses. Learning curves for DOPS items and domains were studied, and multivariable analyses were performed to identify predictors of DOPS competency. RESULTS: Across 279 training units, 10,749 DOPS submitted for 1,199 trainees were analyzed. The acceptable reliability threshold (G > 0.70) was achieved with 3 assessors performing 2 DOPS each. DOPS competency rates correlated with the unassisted caecal intubation rate (rho 0.404, P < 0.001). Demonstrating competency in 90% of assessed items provided optimal sensitivity (90.2%) and specificity (87.2%) for benchmarking overall DOPS competence. This threshold was attained in the following order: "preprocedure" (50-99 procedures), "endoscopic nontechnical skills" and "postprocedure" (150-199), "management" (200-249), and "procedure" (250-299) domain. At item level, competency in "proactive problem solving" (rho 0.787) and "loop management" (rho 0.780) correlated strongest with the overall DOPS rating (P < 0.001) and was the last to develop. Lifetime procedure count, DOPS count, trainer specialty, easier case difficulty, and higher cecal intubation rate were significant multivariable predictors of DOPS competence. DISCUSSION: This study establishes milestones for competency acquisition during colonoscopy training and provides novel validity and reliability evidence to support colonoscopy DOPS as a competency assessment tool.

Curriculum for optical diagnosis training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

This manuscript represents an official Position Statement of the European Society of Gastrointestinal Endoscopy (ESGE) aiming to guide general gastroenterologists to develop and maintain skills in optical diagnosis during endoscopy. In general, this requires additional training beyond the core curriculum currently provided in each country. In this context, ESGE have developed a European core curriculum for optical diagnosis practice across Europe for high quality optical diagnosis training. 1: ESGE suggests that every endoscopist should have achieved general competence in upper and/or lower gastrointestinal (UGI/LGI) endoscopy before commencing training in optical diagnosis of the UGI/LGI tract, meaning personal experience of at least 300 UGI and/or 300 LGI endoscopies and meeting the ESGE quality measures for UGI/LGI endoscopy. ESGE suggests that every endoscopist should be able and competent to perform UGI/LGI endoscopy with high definition white light combined with virtual and/or dye-based chromoendoscopy before commencing training in optical diagnosis. 2: ESGE suggests competency in optical diagnosis can be learned by attending a validated optical diagnosis training course based on a validated classification, and self-learning with a minimum number of lesions. If no validated training course is available, optical diagnosis can only be learned by attending a non-validated onsite training course and self-learning with a minimum number of lesions. 3: ESGE suggests endoscopists are competent in optical diagnosis after meeting the pre-adoption and learning criteria, and meeting competence thresholds by assessing a minimum number of lesions prospectively during real-time endoscopy. ESGE suggests ongoing in vivo practice by endoscopists to maintain competence in optical diagnosis. If a competent endoscopist does not perform in vivo optical diagnosis on a regular basis, ESGE suggests repeating the learning and competence phases to maintain competence.Key areas of interest were optical diagnosis training in Barrett's esophagus, esophageal squamous cell carcinoma, early gastric cancer, diminutive colorectal lesions, early colorectal cancer, and neoplasia in inflammatory bowel disease. Condition-specific recommendations are provided in the main document.

Curriculum for small-bowel capsule endoscopy and device-assisted enteroscopy training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

The European Society of Gastrointestinal Endoscopy (ESGE) has recognized the need to formalize training in small-bowel endoscopy across European centers. The following criteria and framework for training in small-bowel capsule endoscopy (SBCE) and device-assisted enteroscopy (DAE), which aim to provide uniform and high quality training to ensure that small-bowel endoscopists are competent to operate independently, are based on the current literature and experience of experts in the field. Three main areas are covered: skills required prior to commencing training in small-bowel endoscopy; structured training for trainees to become independent endoscopists; and ways of ensuring competence is achieved. 1 : Centers providing training in SBCE should perform a minimum of 75 - 100 SBCEs/year. 2 : Experience in bidirectional endoscopies is desirable for structured training in SBCE. 3 : SBCE courses should consist of at least 50 % hands-on training and cover information on technology, indications and contraindications for SBCE, pathologies that can be encountered on SBCE, and standard terminology that should be used during reporting of SBCE. An SBCE course should be completed prior to achieving competence in SBCE reporting. 4 : Competence in SBCE can be assessed by considering a minimum of 30 SBCEs. Direct Observation of Procedural Skills, short SBCE videos, and multiple-choice questions can be useful to assess improvement in the skills of trainees. 5 : Centers offering training in DAE should aim to carry out at least 75 DAEs/year, should have direct links with an SBCE service, and should allow regular discussion of cases at a radiology small-bowel MDT. Training centers with lower numbers are encouraged to offer training by "buddying-up" with other centers, or using mentoring systems. 6 : DAE trainees must be independent in bidirectional endoscopies and have experience in level 1 polypectomy prior to commencement of training. They should also be competent in reviewing SBCEs. 7 : Training in DAE should be structured with a minimum of 75 procedures, including 35 retrograde DAEs, with therapeutic procedures undertaken in at least 50 % of the DAEs performed. Training should cover the indications, contraindications, complications including prevention, and technicalities of the DAE procedure; formal evaluation should follow. DAE trainees must acquire skills to independently manage and advise on small-bowel pathology following DAE procedures. 8 : It is highly recommended that international societies develop online modules and courses on DAE, which are currently lacking across Europe.

Correction to: Direct observation of procedural skills (DOPS) assessment in diagnostic gastroscopy: nationwide evidence of validity and competency development during training.

The citation for Reference 22 should be replaced with: Kumar NL, Kugener G, Perencevich ML, et al (2018) The SAFE-T assessment tool: derivation and validation of a web-based application for point-of-care evaluation of gastroenterology fellow performance in colonoscopy. Gastrointest Endosc 87(1):262-269.

Direct observation of procedural skills (DOPS) assessment in diagnostic gastroscopy: nationwide evidence of validity and competency development during training.

BACKGROUND: Validated competency assessment tools and the data supporting milestone development during gastroscopy training are lacking. We aimed to assess the validity of the formative direct observation of procedural skills (DOPS) assessment tool in diagnostic gastroscopy and study competency development using DOPS. METHODS: This was a prospective multicentre (N = 275) analysis of formative gastroscopy DOPS assessments. Internal structure validity was tested using exploratory factor analysis and reliability estimated using generalisability theory. Item and global DOPS scores were stratified by lifetime procedure count to define learning curves, using a threshold determined from receiver operator characteristics (ROC) analysis. Multivariable binary logistic regression analysis was performed to identify independent predictors of DOPS competence. RESULTS: In total, 10086 DOPS were submitted for 987 trainees. Exploratory factor analysis identified three distinct item groupings, representing 'pre-procedure', 'technical', and 'post-procedure non-technical' skills. From generalisability analyses, sources of variance in overall DOPS scores included trainee ability (31%), assessor stringency (8%), assessor subjectivity (18%), and trainee case-to-case variation (43%). The combination of three assessments from three assessors was sufficient to achieve the reliability threshold of 0.70. On ROC analysis, a mean score of 3.9 provided optimal sensitivity and specificity for determining competency. This threshold was attained in the order of 'pre-procedure' (100-124 procedures), 'technical' (150-174 procedures), 'post-procedure non-technical' skills (200-224 procedures), and global competency (225-249 procedures). Higher lifetime procedure count, DOPS count, surgical trainees and assessors, higher trainee seniority, and lower case difficulty were significant multivariable predictors of DOPS competence. CONCLUSION: This study establishes milestones for competency acquisition during gastroscopy training and provides validity and reliability evidence to support gastroscopy DOPS as a competency assessment tool.

ERCP assessment tool: evidence of validity and competency development during training.

BACKGROUND: The endoscopic retrograde cholangiopancreatography (ERCP) direct observation of procedural skills (DOPS) is a 27-item competency assessment tool that was developed to support UK ERCP training. We evaluated validity of ERCP DOPS and competency development during training. METHODS: This prospective study analyzed ERCP DOPS performed in the UK between July 2016 and October 2018. Reliability was measured using Cronbach's alpha, and DOPS scores were benchmarked using the contrasting groups method. The percentage of competent scores was averaged for each item, domain, and overall rating, and stratified by lifetime procedure count to evaluate learning curves. Multivariable analyses were performed to identify predictors of DOPS competence. RESULTS: 818 DOPS (109 trainees, 80 UK centers) were analyzed. Overall Cronbach's alpha was 0.961. Attaining competency in 87 % of assessed DOPS items provided the optimal competency benchmark. This was achieved in the domain sequence of: pre-procedure, post-procedure management, endoscopic non-technical skills, cannulation & imaging, and execution of selected therapy, and across all items after 200 - 249 procedures (89 %). After 300 procedures, the benchmark was reached for selective cannulation (89 %), but not for stenting (plastic 73 %; metal 70 %), sphincterotomy (80 %), and sphincteroplasty (56 %). On multivariable analysis, lifetime procedure count (P = 0.002), easier case difficulty (P < 0.001), trainee grade (P = 0.03), and higher lifetime DOPS count (P = 0.01) were predictors of DOPS competence. CONCLUSION: This study provides novel validity, reliability, and learning curve data for ERCP DOPS. Trainees should have a minimum of 300 hands-on ERCP procedures before undertaking summative assessment for independent practice.

Curriculum for endoscopic submucosal dissection training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

There is a need for well-organized comprehensive strategies to achieve good training in ESD. In this context, the European Society of Gastrointestinal Endoscopy (ESGE) have developed a European core curriculum for ESD practice across Europe with the aim of high quality ESD training.Advanced endoscopy diagnostic practice is advised before initiating ESD training. Proficiency in endoscopic mucosal resection (EMR) and adverse event management is recommended before starting ESD trainingESGE discourages the starting of initial ESD training in humans. Practice on animal and/or ex vivo models is useful to gain the basic ESD skills. ESGE recommends performing at least 20 ESD procedures in these models before human practice, with the goal of at least eight en bloc complete resections in the last 10 training cases, with no perforation. ESGE recommends observation of experts performing ESD in tertiary referral centers. Performance of ESD in humans should start on carefully selected lesions, ideally small ( < 30 mm), located in the antrum or in the rectum for the first 20 procedures. Beginning human practice in the colon is not recommended. ESGE recommends that at least the first 10 human ESD procedures should be done under the supervision of an ESD-proficient endoscopist.Endoscopists performing ESD should be able to correctly estimate the probability of performing a curative resection based on the characteristics of the lesion and should know the benefit/risk relationship of ESD when compared with other therapeutic alternatives. Endoscopists performing ESD should know how to interpret the histopathology findings of the ESD specimen, namely the criteria for low risk resection ("curative"), local risk resection, and high risk resection ("non-curative"), as well as their implications. ESD should be performed only in a setting where early and delayed complications can be managed adequately, namely with the possibility of admitting patients to a ward, and access to appropriate emergency surgical teams for the organ being treated with ESD.

Changes in scoring of Direct Observation of Procedural Skills (DOPS) forms and the impact on competence assessment.

BACKGROUND: Direct Observation of Procedural Skills (DOPS) is an established competence assessment tool in endoscopy. In July 2016, the DOPS scoring format changed from a performance-based scale to a supervision-based scale. We aimed to evaluate the impact of changes to the DOPS scale format on the distribution of scores in novice trainees and on competence assessment. METHODS: We performed a prospective, multicenter (n = 276), observational study of formative DOPS assessments in endoscopy trainees with ≤ 100 lifetime procedures. DOPS were submitted in the 6-months before July 2016 (old scale) and after (new scale) for gastroscopy (n = 2998), sigmoidoscopy (n = 1310), colonoscopy (n = 3280), and polypectomy (n = 631). Scores for old and new DOPS were aligned to a 4-point scale and compared. RESULTS: 8219 DOPS (43 % new and 57 % old) submitted for 1300 trainees were analyzed. Compared with old DOPS, the use of the new DOPS was associated with greater utilization of the lowest score (2.4 % vs. 0.9 %; P < 0.001), broader range of scores, and a reduction in competent scores (60.8 % vs. 86.9 %; P < 0.001). The reduction in competent scores was evident on subgroup analysis across all procedure types (P < 0.001) and for each quartile of endoscopy experience. The new DOPS was superior in characterizing the endoscopy learning curve by demonstrating progression of competent scores across quartiles of procedural experience. CONCLUSIONS: Endoscopy assessors applied a greater range of scores using the new DOPS scale based on degree of supervision in two cohorts of trainees matched for experience. Our study provides construct validity evidence in support of the new scale format.

Paediatric pancreaticobiliary endoscopy: a 21-year experience from a tertiary hepatobiliary centre and systematic literature review.

BACKGROUND: In adults ERCP and endoscopic ultrasound (EUS) are standard methods of evaluating and treating many hepatopancreaticobiliary (HPB) conditions. HPB disease is being diagnosed with increasing frequency in children but information about role of ERCP and EUS and their outcomes in this population remain limited. Therefore the aims of this study were to describe the paediatric ERCP and EUS experience from a large tertiary referral HPB centre, and to systematically compare outcomes with those of other published series. METHODS: All patients <18 years undergoing an ERCP or EUS between January 1992-December 2014 were included. Indications for the procedure, rates of technical success, procedural adverse events and reinterventions were recorded in all cases. RESULTS: Ninety children underwent 111 procedures (87 ERCPs and 24 EUS). 53% (48) were female with a median age of 14 years (range: 3 months - 17 years). Procedures were performed under general anaesthesia (n = 48) or conscious sedation (n = 63). Common indications for ERCP included chronic or recurrent pancreatitis and biliary obstruction. Patients frequently had multiple comorbidities, with a median ASA grade of 2 (range 1-4). Therapeutic procedures performed included biliary or pancreatic sphincterotomy, common bile duct or pancreatic duct stone removal, biliary or pancreatic stent insertion, EUS-guided fine needle aspiration and endoscopic transmural drainage of pancreatic fluid collections. No adverse events were reported following ERCP but there was one complication requiring surgery following EUS guided cystenterostomy. CONCLUSION: ERCP and EUS in children and adolescents have high technical success rates and low rates of adverse events when performed in high volume HPB centres.

Diagnosis of pancreaticobiliary malignancy by detection of minichromosome maintenance protein 5 in biliary brush cytology.

BACKGROUND: Biliary brush cytology is the standard method of evaluating biliary strictures, but is insensitive at detecting malignancy. In pancreaticobiliary cancer minichromosome maintenance replication proteins (MCM 2-7) are dysregulated in the biliary epithelium and MCM5 levels are elevated in bile samples. This study aimed to validate an immunocolorimetric ELISA assay for MCM5 as a pancreaticobiliary cancer biomarker in biliary brush samples. METHODS: Biliary brush specimens were collected prospectively at ERCP from patients with a biliary stricture. Collected samples were frozen at -80 °C. The supernatant was washed and lysed cells incubated with HRP-labelled anti-MCM5 mouse monoclonal antibody. Test positivity was determined by optical density absorbance. Patients underwent biliary brush cytology or additional investigations as per clinical routine. RESULTS: Ninety-seven patients were included in the study; 50 had malignant strictures. Median age was 65 years (range 21-94) and 51 were male. Compared with final diagnosis the MCM5 assay had a sensitivity for malignancy of 65.4% compared with 25.0% for cytology. In the 72 patients with paired MCM5 assay and biliary brush cytology, MCM5 demonstrated an improved sensitivity (55.6% vs 25.0%; P=0.0002) for the detection of malignancy. CONCLUSIONS: Minichromosome maintenance replication protein5 is a more sensitive indicator of pancreaticobiliary malignancy than standard biliary brush cytology.

Preventing Post-ERCP Pancreatitis: The Role of Prophylactic Pancreatic Duct Stenting in the Rectal NSAID Era.

BACKGROUND: Rectal non-steroidal anti-inflammatory drug at endoscopic retrograde cholangiopancreatography is now the standard of care to reduce the risk of post-ERCP pancreatitis. Pancreatic duct stenting also reduces the risk of post- ERCP pancreatitis in high-risk patients, but failed pancreatic duct stenting carries an increased PEP rate (up to 35%). STUDY AIM: To assess the impact on post-ERCP pancreatitis of successful and unsuccessful pancreatic duct stent placement in the setting of universal rectal non-steroidal anti-inflammatory drug use. METHODS: Between 2013-2015, all patients undergoing endoscopic retrograde cholangiopancreatographys in our tertiary referral centre (where rectal non-steroidal anti-inflammatory drugs are used routinely) were included. The electronic patient's records were reviewed and the following parameters were analysed: indication for pancreatic duct stenting; deployment success; and adverse events. RESULTS: A total of 1633 endoscopic retrograde cholangiopancreatographys were performed, and pancreatic duct stenting was attempted in 324 cases (20%), with successful placement in 307 patients (95%). Contra-indications to non-steroidal anti-inflammatory drugs were found in 106 (6.5%) patients. Prophylactic stenting failed in 12 of 213 patients; of whom one patient developed post-ERCP pancreatitis (8%). Eighteen (9%) patients with prophylactic pancreatic duct stents developed post-ERCP pancreatitis compared to 1.4% without prophylactic stents (RR 8.4, p=0.04). CONCLUSION: A lack of difference in post-ERCP pancreatitis in those who underwent successful, and unsuccessful, pancreatic duct stent placement may reflect the protective effect of non-steroidal anti-inflammatory drugs. This data adds to evidence suggesting that pancreatic duct stenting may be less important, even in high-risk patients, with the widespread use of non-steroidal anti-inflammatory drugs.