What Would Be the Appropriate Number of Clinical ERCP Cases for Trainees to Acquire Basic Competence? A Systematic Review and Meta-Analysis.

Endoscopic retrograde cholangiopancreatography (ERCP) is technically demanding and carries significant risks. It is performed by gastrointestinal and surgical endoscopists. There is no consensus on the minimum number of ERCPs required during training. This study was conducted to analyze the minimum number of clinical ERCPs that a trainee needs to perform to achieve competency. PubMed, Ovid-Embase, and the Cochrane library were searched systematically for prospective and retrospective studies reporting on trainees' ERCP performance. Mete-analysis was conducted to analyze the success rate of cannulation, other basic techniques, and adverse event rate, using the random-effect model with Review Manager 5.3. Thirteen studies met the inclusion criteria, with 149 trainees performing a total of 18 794 ERCP procedures. The pooled cannulation success rate was 85.7% (95% CI: 78.1%-91.0%) at completion of training. The cannulation success rate was 76.5% (95% CI: 69.2%-82.5%) when the trainees had completed 180 ERCPs, which increased to 81.8% (95% CI: 69.8%-90.6%) after 200 ERCP procedures. Adverse events and post-ERCP pancreatitis rates were 4.7% (95% CI: 2.9%-9.1%) and 2.0% (0.9%-3.9%), respectively. Achieving a cannulation success rate of >90% was considered a quality indicator for ERCP training by most societal guidelines. However, our retrospective analysis indicated that trainees only attained a pooled cannulation success rate of only 81.8% after 200 procedures. Therefore, the minimum number of ERCPs required to achieve competency during training may need to be redefined to meet the basic requirement.

Laparoscopic appendectomy as an index procedure for surgical trainees: clinical outcomes and learning curve.

Surgical training is essential to maintain safety standards in healthcare. The aim of this study is to evaluate learning curves and short-term postoperative outcomes of laparoscopic appendectomy (LA) performed by trainees (TRN) and attendings (ATT). The present study included the medical records of patients with acute appendicitis who underwent a fully LA in our department between January 2013 and December 2018. Cases were divided into trainees (TRN and ATT groups based on the experience of the operating surgeon. The primary outcome measures were 30-day morbidity and mortality. Preoperative patients' clinical characteristics, intraoperative findings, operative times, and postoperative hospitalization were compared. Operative times were used to extrapolate learning curves and evaluate the effects of changes in faculty using CUSUM charts. A propensity score matching analysis was performed to reduce differences between cohorts regarding both preoperative characteristics and intraoperative findings. A total of 1173 patients undergoing LA for acute appendicitis were included, of whom 521 (45%) in the TRN group and 652 (55%) in the ATT group. No significant differences were found between the two groups in terms of complication rates, operative times and length of hospital stay. However, CUSUM chart analysis showed decreased operating times in the TRN group. Operative times improved more quickly for advanced cases. The results of this study indicate that LA can be performed by trainees without detrimental effects on clinical outcomes, procedural safety, and operative times. However, the learning curve is longer than previously acknowledged.

Attending Training Courses on Barrett's Esophagus Improves Adherence to Guidelines: A Survey from the Italian Society of Digestive Endoscopy.

BACKGROUND: Little is known on practice patterns of endoscopists for the management of Barrett's esophagus (BE) over the last decade. AIMS: Our aim was to assess practice patterns of endoscopists for the diagnosis, surveillance and treatment of BE. METHODS: All members of the Italian Society of Digestive Endoscopy (SIED) were invited to participate to a questionnaire-based survey. The questionnaire included questions on demographic and professional characteristics, and on diagnosis and management strategies for BE. RESULTS: Of the 883 SIED members, 259 (31.1%) completed the questionnaire. Of these, 73% were males, 42.9% had > 50 years of age and 68.7% practiced in community hospitals. The majority (82.9%) of participants stated to use the Prague classification; however 34.5% did not use the top of gastric folds to identify the gastro-esophageal junction (GEJ); only 51.4% used advanced endoscopy imaging routinely. Almost all respondents practiced endoscopic surveillance for non-dysplastic BE, but 43.7% performed eradication in selected cases and 30% practiced surveillance every 1-2 years. The majority of endoscopists managed low-grade dysplasia with surveillance (79.1%) and high-grade dysplasia with ablation (77.1%). Attending a training course on BE in the previous 5 years was significantly associated with the use of the Prague classification (OR 4.8, 95% CI 1.9-12.1), the top of gastric folds as landmark for the GEJ (OR 2.45, 95% CI 1.27-4.74) and advanced imaging endoscopic techniques (OR 3.33, 95% CI 1.53-7.29). CONCLUSIONS: Practice patterns for management of BE among endoscopists are variable. Attending training courses on BE improves adherence to guidelines.

Learning curve of double-guidewire technique by trainees during hands-on endoscopic retrograde cholangiopancreatography training.

BACKGROUND AND AIMS: Double-guidewire technique (DWT) has been successfully performed by experts in difficult biliary cannulation as an advanced technique. This study aimed to define the learning curve and safety of DWT by trainees during hands-on endoscopic retrograde cholangiopancreatography (ERCP) training. METHODS: Patients were eligible for inclusion in the study if the biliary cannulation was difficult and the pancreatic duct was inadvertently cannulated. DWT was performed by two trainees randomly under trainers' guidance. The primary outcome was the success rate of DWT biliary cannulation of trainees. Cumulative sum analysis was used to generate visual learning curves. RESULTS: A total of 60 patients with difficult cannulation were enrolled. The main indications for ERCP were common bile duct stones (65%) and biliary stricture (31.7%). The learning curve analysis showed that to achieve a 70% rate of successful DWT, 12 procedures were needed for trainee A and 15 for trainee B. Higher targeted success rate of DWT could be achieved if the number of DWT procedures increased. Compared with the early stage of learning DWT (case 1 to 15 for each trainee), trainees had significantly higher DWT success rate in the late stage (36.7% [11/30] vs 80% [24/30], P = 0.001). The final success rate of cannulation was 98.3% (59/60). The overall rate of post-ERCP pancreatitis and adverse events was 6.7% (4/60) and 8.3% (5/60), respectively. CONCLUSIONS: Double-guidewire technique was safely performed by two novel trainees during hands-on ERCP training. Fifteen procedures may be enough for trainees to achieve the competency of performing DWT. (Clinicaltrials.gov number: NCT03707613).

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.

A Prospective Multicenter Study Evaluating Endoscopy Competence Among Gastroenterology Trainees in the Era of the Next Accreditation System.

PURPOSE: The Next Accreditation System requires training programs to demonstrate competence among trainees. Within gastroenterology (GI), there are limited data describing learning curves and structured assessment of competence in esophagogastroduodenoscopy (EGD) and colonoscopy. In this study, the authors aimed to demonstrate the feasibility of a centralized feedback system to assess endoscopy learning curves among GI trainees in EGD and colonoscopy. METHOD: During academic year 2016-2017, the authors performed a prospective multicenter cohort study, inviting participants from multiple GI training programs. Trainee technical and cognitive skills were assessed using a validated competence assessment tool. An integrated, comprehensive data collection and reporting system was created to apply cumulative sum analysis to generate learning curves that were shared with program directors and trainees on a quarterly basis. RESULTS: Out of 183 fellowships invited, 129 trainees from 12 GI fellowships participated, with an overall trainee participation rate of 72.1% (93/129); the highest participation level was among first-year trainees (90.9%; 80/88), and the lowest was among third-year trainees (51.2%; 27/53). In all, 1,385 EGDs and 1,293 colonoscopies were assessed. On aggregate learning curve analysis, third-year trainees achieved competence in overall technical and cognitive skills, while first- and second-year trainees demonstrated the need for ongoing supervision and training in the majority of technical and cognitive skills. CONCLUSIONS: This study demonstrated the feasibility of using a centralized feedback system for the evaluation and documentation of trainee performance in EGD and colonoscopy. Furthermore, third-year trainees achieved competence in both endoscopic procedures, validating the effectiveness of current training programs.

Competency in esophagogastroduodenoscopy: a validated tool for assessment and generalizable benchmarks for gastroenterology fellows.

BACKGROUND AND AIMS: The Assessment of Competency in Endoscopy (ACE) tools for colonoscopy and EGD were both put forth by the Training Committee of the American Society for Gastrointestinal Endoscopy (ASGE), with the intent of providing teachers and programs a means to continuously assess fellow skills in these procedures throughout their years of training. Despite the availability of the tools, there are no data that define when competency in EGD has been reached. The goal of this study is to validate the EGD ACE tool (ACE-E) and for the first time describe learning curves and competency benchmarks for EGD by examining a large national cohort of trainees. METHODS: In a prospective, multicenter trial, gastroenterology fellows at all stages of training had their core cognitive and motor skills in EGDs assessed by staff using the ACE-E tool. Evaluations occurred at set intervals of every 50 procedures over an academic year. Like the previously reported and validated ACE tool for colonoscopy, the ACE-E tool uses a 4-point grading scale to define a skills continuum from novice to competent. At each assessment interval, average scores for each skill were computed and overall competency benchmarks for each skill were established using the contrasting groups method. RESULTS: Ninety-six GI fellows at 10 U.S. academic institutions had 1002 EGDs assessed using the ACE-E tool. Average ACE-E scores of 3.5 were found to be inclusive of all minimal competency thresholds identified for each core skill. In addition, independent intubation of the second part of the duodenum (D2) at rates of ≥95% as well as D2 intubation times of ≤4.75 minutes and average total procedure times of ≤12.5 minutes were identified as the points separating competent from non-competent groups. Although the average fellow achieves the D2 intubation rates and time criteria by 100 and 150 procedures, respectively, achieving ACE-E threshold scores on the remaining metrics was typically not achieved until 200 to 250 procedures. CONCLUSIONS: Nationally generalizable learning curves for EGD skills in GI fellows are described. Average ACE-E scores of 3.5, independent D2 intubation rates of 95%, and D2 intubation times of ≤4.75 minutes are recommended as minimum competency criteria. On average, it takes GI fellows only 150 procedures to simply drive the scope adequately but 250 procedures to achieve minimum competence in the remaining cognitive and motor skills. The D2 intubation rate threshold and learning curve found in this multicenter cohort using the ACE-E tool are similar to those recently described by researchers in the United Kingdom; however, development of cognitive and overall competence requires a higher procedure threshold than previously described.

Radiation Training, Radiation Protection, and Fluoroscopy Utilization Practices Among US Therapeutic Endoscopists.

BACKGROUND: Fluoroscopy use during ERCP exposes patients and providers to deleterious effects of radiation. Formal training in fluoroscopy/radiation protection is not widely emphasized during therapeutic endoscopy training, and radiation use during GI endoscopy has not previously been characterized in the USA. In this study, we evaluated radiation training, fluoroscopy use patterns, and radiation protection practices among US therapeutic endoscopists. METHODS: An anonymous electronic survey was distributed to US therapeutic endoscopists, and responses were analyzed using descriptive statistics. State-specific requirements for fluoroscopy utilization were determined from state radiologic health branches. RESULTS: A total of 159 endoscopists (response rate 67.8%) predominantly those working in university hospitals (69.2%) with > 5 years of experience performing ERCP (74.9%) completed the questionnaire. Although the majority of endoscopists (61.6%) reported that they personally controlled fluoroscopy during ERCP, most (56.6%) had not received training on operating their fluoroscopy system. Only a minority (18-31%) of all respondents reported consistently utilizing modifiable fluoroscopy system parameters that minimize patient radiation exposure (pulsed fluoroscopy, frame rate modification or collimation). Endoscopists appear to undertake adequate personal radiation protective measures although use of a dosimeter was not consistent in half of respondents. The majority of states (56.8%) do not have any stated requirement for certification of non-radiologist physicians who intend to operate fluoroscopy. CONCLUSIONS: Most US gastroenterologists performing ERCP have not received formal training in operating their fluoroscopy system or in minimizing radiation exposure to themselves and to their patients. Such formal training should be included in all therapeutic endoscopy training programs, and fluoroscopy system-specific training should be offered at all hospitals.

Setting minimum standards for training in EUS and ERCP: results from a prospective multicenter study evaluating learning curves and competence among advanced endoscopy trainees.

BACKGROUND AND AIMS: Minimum EUS and ERCP volumes that should be offered per trainee in "high quality" advanced endoscopy training programs (AETPs) are not established. We aimed to define the number of procedures required by an "average" advanced endoscopy trainee (AET) to achieve competence in technical and cognitive EUS and ERCP tasks to help structure AETPs. METHODS: American Society for Gastrointestinal Endoscopy (ASGE)-recognized AETPs were invited to participate; AETs were graded on every fifth EUS and ERCP examination using a validated tool. Grading for each skill was done using a 4-point scoring system, and learning curves using cumulative sum analysis for overall, technical, and cognitive components of EUS and ERCP were shared with AETs and trainers quarterly. Generalized linear mixed-effects models with a random intercept for each AET were used to generate aggregate learning curves, allowing us to use data from all AETs to estimate the average learning experience for trainees. RESULTS: Among 62 invited AETPs, 37 AETs from 32 AETPs participated. Most AETs reported hands-on EUS (52%, median 20 cases) and ERCP (68%, median 50 cases) experience before starting an AETP. The median number of EUS and ERCPs performed per AET was 400 (range, 200-750) and 361 (range, 250-650), respectively. Overall, 2616 examinations were graded (EUS, 1277; ERCP-biliary, 1143; pancreatic, 196). Most graded EUS examinations were performed for pancreatobiliary indications (69.9%) and ERCP examinations for ASGE biliary grade of difficulty 1 (72.1%). The average AET achieved competence in core EUS and ERCP skills at approximately 225 and 250 cases, respectively. However, overall technical competence was achieved for grade 2 ERCP at about 300 cases. CONCLUSION: The thresholds provided for an average AET to achieve competence in EUS and ERCP may be used by the ASGE and AETPs in establishing the minimal standards for case volume exposure for AETs during their training. (Clinical trial registration number: NCT02509416.).

Endoscopic foregut surgery and interventions: The future is now. The state-of-the-art and my personal journey.

In this paper, I reviewed the emerging field of endoscopic surgery and present data supporting the contention that endoscopy can now be used to treat many foregut diseases that have been traditionally treated surgically. Within each topic, the content will progress as follows: "lessons learned", "technical considerations" and "future opportunities". Lessons learned will provide a brief background and update on the most current literature. Technical considerations will include my personal experience, including tips and tricks that I have learned over the years. Finally, future opportunities will address current unmet needs and potential new areas of development. The foregut is defined as "the upper part of the embryonic alimentary canal from which the pharynx, esophagus, lung, stomach, liver, pancreas, and part of the duodenum develop". Foregut surgery is well established in treating conditions such as gastroesophageal reflux disease (GERD), achalasia, esophageal diverticula, Barrett's esophagus (BE) and esophageal cancer, stomach cancer, gastric-outlet obstruction, and obesity. Over the past decade, remarkable progress in interventional endoscopy has culminated in the conceptualization and practice of endoscopic foregut surgery for various clinical conditions summarized in this paper. Regarding GERD, there are now several technologies available to effectively treat it and potentially eliminate symptoms, and the need for long-term treatment with proton pump inhibitors. For the first time, fundoplication can be performed without the need for open or laparoscopic surgery. Long-term data going out 5-10 years are now emerging showing extended durability. In respect to achalasia, per-oral endoscopic myotomy (POEM) which was developed in Japan, has become an alternative to the traditional Heller's myotomy. Recent meta-analysis show that POEM may have better results than Heller, but the issue of post-POEM GERD still needs to be addressed. There is now a resurgence of endoscopic treatment of Zenker's diverticula with improved technique (Z-POEM) and equipment; thus, patients are choosing flexible endoscopic treatment as opposed to open or rigid endoscopy options. In regard to BE, endoscopic submucosal dissection (ESD) which is well established in Asia, is now becoming more mainstream in the West for the treatment of BE with high grade dysplasia, as well as early esophageal cancer. In combination with all the ablation technologies (radiofrequency ablation, cryotherapy, hybrid argon plasma coagulation), the entire spectrum of Barrett's and related dysplasia and early cancer can be managed predominantly by endoscopy. Importantly, in regard to early gastric cancer and submucosal tumors (SMTs) of the stomach, ESD and full thickness resection (FTR) can excise these lesions en-bloc and endoscopic suturing is now used to close large defects and perforations. For treatment of patients with malignant gastric outlet obstruction (GOO), endoscopic gastro-jejunostomy is now showing better results than enteral stenting. G-POEM is also emerging as a treatment option for patients with gastroparesis. Obesity has become an epidemic in many western countries and is becoming also prevalent in Asia. Endoscopic sleeve gastroplasty (ESG) is now becoming an established treatment option, especially for obese patients with body mass index between 30 and 35. Data show an average weight loss of 16 kg after ESG with long-term data confirming sustainability. Finally, in respect to endo-hepatology, there are many new endoscopic interventions that have been developed for patients with liver disease. Endoscopic ultrasound (EUS)-guided liver biopsy and EUS-guided portal pressure measurement are exciting new frontiers for the endo-hepatologists.

Three-Dimensional Printing Facilitates Creation of a Biliary Endoscopy Phantom for Interventional Radiology-Operated Endoscopy Training.

PURPOSE: To create a three-dimensional endoscopic model of the biliary tract from magnetic-resonance cholangiopancreatography imaging and to evaluate its effectiveness as a tool for training in endoscopic biliary interventions. MATERIALS AND METHODS: A magnetic-resonance cholangiopancreatography study was performed on a patient with biliary obstruction secondary to a distal bile duct cholangiocarcinoma. Using Vitrea, a three-dimensional volume-rendered image was created, and exported as a standard tessellated language file. The standard tessellated language model was then edited with MeshMixer. Three cylindrical entry ports were created. The ports were aligned and overlapped with the dominant ducts in three separate areas of the model and fused to the model. A 0.2 cm shell was created around the model and the model was hollowed. The ends of the ports were cut off, allowing access to the hollowed-out model. The model was printed at 125% scale to allow easy access with a 9.5-French (≤3.23 mm) endoscope. The model was printed using a Stratasys Dimension Elite Plus printer. After printing, the model was post-processed to remove support materials. A 10-question survey was administered to all trainees before and after use of the printed phantom to practice endoscopy skills. RESULTS: 11 trainees participated in the three-dimensional endoscopy simulation with most of the trainees (73%) having no prior formal endoscopy training. Using a 10-point Likert scale, the mean comfort-level of the trainees to use endoscopy alone for cholecystostomy, percutaneous biliary drainage, percutaneous nephrostomy, and percutaneous gastrostomy increased by 38.9%, 32.8%, 32.8%, and 34.3%, respectively, following the training experience. CONCLUSION: The use of a three-dimensionally printed endoscopic model as a simulation tool has the potential to improve trainee comfort using endoscopy during interventional radiology procedures.