Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial).

BACKGROUND & AIMS: Endoscopic ultrasound-guided choledochoduodenostomy with a lumen-apposing metal stent (EUS-CDS) is a promising modality for management of malignant distal biliary obstruction (MDBO) with potential for better stent patency. We compared its outcomes with endoscopic retrograde cholangiopancreatography with metal stenting (ERCP-M). METHODS: In this multicenter randomized controlled trial, we recruited patients with MDBO secondary to borderline resectable, locally advanced, or unresectable peri-ampullary cancers across 10 Canadian institutions and 1 French institution. This was a superiority trial with a noninferiority assessment of technical success. Patients were randomized to EUS-CDS or ERCP-M. The primary end point was the rate of stent dysfunction at 1 year, considering competing risks of death, clinical failure, and surgical resection. Analyses were performed according to intention-to-treat principles. RESULTS: From February 2019 to February 2022, 144 patients were recruited; 73 were randomized to EUS-CDS and 71 were randomized to ERCP-M. The mean (SD) procedure time was 14.0 (11.4) minutes for EUS-CDS and 23.1 (15.6) minutes for ERCP-M (P < .01); 40% of the former was performed without fluoroscopy. Technical success was achieved in 90.4% (95% CI, 81.5% to 95.3%) of EUS-CDS and 83.1% (95% CI, 72.7% to 90.1%) of ERCP-M with a risk difference of 7.3% (95% CI, -4.0% to 18.8%) indicating noninferiority. Stent dysfunction occurred in 9.6% vs 9.9% of EUS-CDS and ERCP-M cases, respectively (P = .96). No differences in adverse events, pancreaticoduodenectomy and oncologic outcomes, or quality of life were noted. CONCLUSIONS: Although not superior in stent function, EUS-CDS is an efficient and safe alternative to ERCP-M in patients with MDBO. These findings provide evidence for greater adoption of EUS-CDS in clinical practice as a complementary and exchangeable first-line modality to ERCP in patients with MDBO. CLINICALTRIALS: gov, Number: NCT03870386.

Endoscopic ultrasound (EUS)-guided fine needle biopsy alone vs. EUS-guided fine needle aspiration with rapid onsite evaluation in pancreatic lesions: a multicenter randomized trial.

BACKGROUND: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is the standard in the diagnosis of solid pancreatic lesions, in particular when combined with rapid onsite evaluation of cytopathology (ROSE). More recently, a fork-tip needle for core biopsy (FNB) has been shown to be associated with excellent diagnostic yield. EUS-FNB alone has however not been compared with EUS-FNA + ROSE in a large clinical trial. Our aim was to compare EUS-FNB alone to EUS-FNA + ROSE in solid pancreatic lesions. METHODS: A multicenter, non-inferiority, randomized controlled trial involving seven centers was performed. Solid pancreatic lesions referred for EUS were considered for inclusion. The primary end point was diagnostic accuracy. Secondary end points included sensitivity/specificity, mean number of needle passes, and cost. RESULTS: 235 patients were randomized: 115 EUS-FNB alone and 120 EUS-FNA + ROSE. Overall, 217 patients had malignant histology. The diagnostic accuracy for malignancy of EUS-FNB alone was non-inferior to EUS-FNA + ROSE at 92.2 % (95 %CI 86.6 %-96.9 %) and 93.3 % (95 %CI 88.8 %-97.9 %), respectively (P = 0.72). Diagnostic sensitivity for malignancy was 92.5 % (95 %CI 85.7 %-96.7 %) for EUS-FNB alone vs. 96.5 % (93.0 %-98.6 %) for EUS-FNA + ROSE (P = 0.46), while specificity was 100 % in both. Adequate histological yield was obtained in 87.5 % of the EUS-FNB samples. The mean (SD) number of needle passes and procedure time favored EUS-FNB alone (2.3 [0.6] passes vs. 3.0 [1.1] passes [P < 0.001]; and 19.3 [8.0] vs. 22.7 [10.8] minutes [P = 0.008]). EUS-FNB alone cost on average 45 US dollars more than EUS-FNA + ROSE. CONCLUSION: EUS-FNB alone is non-inferior to EUS-FNA + ROSE and is associated with fewer needle passes, shorter procedure time, and excellent histological yield at comparable cost.

Is Biannual Surveillance for Pancreatic Cancer Sufficient in Individuals With Genetic Syndromes or Familial Pancreatic Cancer?

BACKGROUND: Individuals with a family history of pancreatic adenocarcinoma (PC) or with a germline mutation in a PC susceptibility gene are at increased risk of developing PC. These high-risk individuals (HRIs) may benefit from PC surveillance. METHODS: A PC surveillance program was developed to evaluate the detection of premalignant lesions and early-stage PCs using biannual imaging and to determine whether locally advanced or metastatic PCs develop despite biannual surveillance. From January 2013 to April 2020, asymptomatic HRIs were enrolled and followed with alternating MRI and endoscopic ultrasound every 6 months. RESULTS: Of 75 HRIs, 43 (57.3%) had a germline mutation in a PC susceptibility gene and 32 (42.7%) had a familial pancreatic cancer (FPC) pedigree. Branch-duct intraductal papillary mucinous neoplasms (BD-IPMNs) were identified in 26 individuals (34.7%), but only 2 developed progressive lesions. One patient with Peutz-Jeghers syndrome (PJS) developed locally advanced PC arising from a BD-IPMN. Whole-genome sequencing of this patient's PC and of a second patient with PJS-associated PC from the same kindred revealed biallelic inactivation of STK11 in a KRAS-independent manner. A review of 3,853 patients from 2 PC registries identified an additional patient with PJS-associated PC. All 3 patients with PJS developed advanced PC consistent with the malignant transformation of an underlying BD-IPMN in <6 months. The other surveillance patient with a progressive lesion had FPC and underwent resection of a mixed-type IPMN that harbored polyclonal KRAS mutations. CONCLUSIONS: PC surveillance identifies a high prevalence of BD-IPMNs in HRIs. Patients with PJS with BD-IPMNs may be at risk for accelerated malignant transformation.

AGA Clinical Practice Update on Endoscopic Therapies for Non-Variceal Upper Gastrointestinal Bleeding: Expert Review.

DESCRIPTION: The purpose of this American Gastroenterological Association (AGA) Institute Clinical Practice Update is to review the available evidence and best practice advice statements regarding the use of endoscopic therapies in treating patients with non-variceal upper gastrointestinal bleeding. METHODS: This expert review was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership, and underwent internal peer review by the Clinical Practice Updates Committee and external peer review through standard procedures of Gastroenterology. This review is framed around the 10 best practice advice points agreed upon by the authors, which reflect landmark and recent published articles in this field. This expert review also reflects the experiences of the authors who are gastroenterologists with extensive experience in managing and teaching others to treat patients with non-variceal upper gastrointestinal bleeding (NVUGIB). BEST PRACTICE ADVICE 1: Endoscopic therapy should achieve hemostasis in the majority of patients with NVUGIB. BEST PRACTICE ADVICE 2: Initial management of the patient with NVUGIB should focus on resuscitation, triage, and preparation for upper endoscopy. After stabilization, patients with NVUGIB should undergo endoscopy with endoscopic treatment of sites with active bleeding or high-risk stigmata for rebleeding. BEST PRACTICE ADVICE 3: Endoscopists should be familiar with the indications, efficacy, and limitations of currently available tools and techniques for endoscopic hemostasis, and be comfortable applying conventional thermal therapy and placing hemoclips. BEST PRACTICE ADVICE 4: Monopolar hemostatic forceps with low-voltage coagulation can be an effective alternative to other mechanical and thermal treatments for NVUGIB, particularly for ulcers in difficult locations or those with a rigid and fibrotic base. BEST PRACTICE ADVICE 5: Hemostasis using an over-the-scope clip should be considered in select patients with NVUGIB, in whom conventional electrosurgical coagulation and hemostatic clips are unsuccessful or predicted to be ineffective. BEST PRACTICE ADVICE 6: Hemostatic powders are a noncontact endoscopic option that may be considered in cases of massive bleeding with poor visualization, for salvage therapy, and for diffuse bleeding from malignancy. BEST PRACTICE ADVICE 7: Hemostatic powder should be preferentially used as a rescue therapy and not for primary hemostasis, except in cases of malignant bleeding or massive bleeding with inability to perform thermal therapy or hemoclip placement. BEST PRACTICE ADVICE 8: Endoscopists should understand the risk of bleeding from therapeutic endoscopic interventions (eg, endoluminal resection and endoscopic sphincterotomy) and be familiar with the endoscopic tools and techniques to treat intraprocedural bleeding and minimize the risk of delayed bleeding. BEST PRACTICE ADVICE 9: In patients with endoscopically refractory NVUGIB, the etiology of bleeding (peptic ulcer disease, unknown source, post surgical); patient factors (hemodynamic instability, coagulopathy, multi-organ failure, surgical history); risk of rebleeding; and potential adverse events should be taken into consideration when deciding on a case-by-case basis between transcatheter arterial embolization and surgery. BEST PRACTICE ADVICE 10: Prophylactic transcatheter arterial embolization of high-risk ulcers after successful endoscopic therapy is not encouraged.

Development and validation of an endoscopic submucosal dissection video assessment tool.

BACKGROUND: Despite a need for assessment of endoscopic submucosal dissection (ESD) skills in order to track progress and determine competence, there is no structured measure of assessing competency in ESD performance. The present study aims to develop and examine validity evidence for an assessment tool to evaluate the recorded performance of ESD for gastric neoplasms. METHODS: The ESD video assessment tool (EVAT) was systematically developed by ESD experienced endoscopists. The EVAT consists of a 25-item global rating scale and 3-item checklist to assess competencies required to perform ESD. Five unedited videos were each evaluated by 2-blinded experienced ESD endoscopists to assess inter-rater reliability using intraclass correlation coefficients (ICC). Seventeen unedited videos in total were rated by 3 blinded experienced ESD endoscopists. Validity evidence for relationship to other variables was examined by comparing scores of inexperienced (fellows) and experienced endoscopists (attending staff), and by evaluating the relationship between the EVAT scores and ESD case experience. Internal consistency was evaluated using Cronbach's alpha. RESULTS: The inter-rater reliability for the total score was high at 0.87 (95% confidence interval 0.11 to 0.99). The total score [median, interquartile range (IQR)] was significantly different between the inexperienced (71, 63-77) and experienced group (95, 91-97) (P = 0.005). The total scores demonstrated high correlation with the number of ESD cases (Spearman's ρ = 0.79, P < 0.01). The internal consistency was 0.97. CONCLUSIONS: This study provides preliminary validity evidence for the assessment of video-recorded ESD performances for gastric neoplasms using EVAT.

Epidemiologic trends and geographic distribution of patients with gallbladder and extrahepatic biliary tract cancers in Canada.

BACKGROUND: Gallbladder and biliary tract cancers are rare malignancies that carry a poor prognosis. Research on their epidemiologic trends is scarce. METHODS: We performed a retrospective analysis of the data in Canada using population-based cancer registries from 1992 to 2010. The incidence and mortality of gallbladder and extrahepatic bile duct cancers were examined at the levels of provinces/territories, cities, and Forward Sortation Area (FSA) postal codes. RESULTS: The incidence and mortality rates decreased over the study period. The average national incidence rate of gallbladder and biliary tract cancers was 30.92 cases per million individuals per year. Higher than average incidence rates were observed in Manitoba, Saskatchewan and Québec; there were contiguous regions with high incidence in Saskatchewan and Manitoba that suggest an area of putative case clustering. Higher incidence of gallbladder cancer was observed in women, whereas higher incidence of extrahepatic bile duct cancers was noted in men. Lower socioeconomic status and Hispanic race were found to be risk factors for gallbladder and biliary tract cancers. CONCLUSION: This is the first study to analyze the burden of gallbladder and biliary tract cancers in Canada. The geographic clustering trends present new avenues for research on environmental triggers.

Advances and Challenges in Endoscopic Training.

One of the challenges of the current era is ensuring that endoscopic training is accomplished effectively in the face of multiple competing demands. As health care delivery evolves, with rising patient complexity and increasing productivity requirements, there is mounting pressure on the time available for training in the clinical setting. The practice of endoscopy itself continues to expand to include increasingly complex procedures (eg, therapeutic endoscopic ultrasound, endoscopic submucosal dissection, and peroral endoscopic myotomy) that require dedicated endoscopy training. The rapid pace of progress in the field of endoscopy means that the demand for endoscopy training is not limited to the formal period of training, but instead spans the spectrum to include physicians already in practice. In light of recent advances in our understanding of endoscopy training, this review will serve to highlight the current state of affairs with respect to endoscopic training and how we can consider approaching these challenges.

ASGE principles of endoscopic training.

This White Paper shares guidance on the important principles of training endoscopy teachers, the focus of an American Society for Gastrointestinal Endoscopy (ASGE)/World Endoscopy Organization Program for Endoscopic Teachers and Leaders of Endoscopic Training held at the ASGE Institute for Training and Technology. Key topics included the need for institutional support and continuous skills development, the importance of consensus and consistency in content and approach to teaching, the role of conscious competence and content breakdown into discreet steps in effective teaching, defining roles of supervisors versus instructors to ensure teaching consistency across instructors, identification of learning environment factors and barriers impacting effective teaching, and individualized training that incorporates effective feedback and adapts with learner proficiency. Incorporating simulators into endoscopy teaching, applying good endoscopy teaching principles outside the endoscopy room, key principles of hands-on training, and effective use of simulators and models in achieving specific learning objectives were demonstrated with rotations through hands-on simulator stations as part of the program. A discussion of competency-based assessment was followed by live sessions in which attendees applied endoscopy teaching principles covered in the program. Conclusions highlighted the need for the following: formal training of endoscopy teachers to a level of conscious competence, incorporation of formal training structures into existing training curricula, intentional teaching preparation, feedback to trainees and instructors alike aimed at improving performance, and competency-based trainee assessment. The article is intended to help motivate individuals who play a role in training other endoscopists to develop their teaching abilities, promote discussions about endoscopy training, and engage both endoscopy trainers and trainees in a highly rewarding learning process that is in the best interest of patients.

Defining competencies for endoscopic submucosal dissection (ESD) for gastric neoplasms.

BACKGROUND: Current methods for teaching and assessing competencies for endoscopic submucosal dissection (ESD) are highly variable, non-systematic, and are inefficient for the learner to acquire adequate skills. The present study aims to define and establish expert consensus regarding competencies required to perform ESD for gastric neoplasms. METHODS: Fourteen ESD experts from 12 institutions in Japan were invited to complete an online survey to rate potential items for their importance in performing ESD proficiently. By using methodology based on the Delphi principles, the results of each round were analyzed and re-sent to the experts until consensus was established. Items were included if ranked 8 out of a 10-point Likert scale, by ≥ 80% of the respondents. RESULTS: A list of 29 potential items was generated through a review of the literature, textbooks, and experience of the steering group members. Ten new items were added through the survey. Consensus was reached after three rounds. Response rate ranged from 93 to 100%. Thirty-four items achieved consensus as important surrogates of competency in performing ESD. CONCLUSIONS: Essential competencies for performing ESD were identified through expert consensus. These competencies can serve as the foundation for structured training and for development of objective assessment tools to evaluate trainee performance in ESD.

Learning curves in ERCP during advanced endoscopy training: a Canadian multicenter prospective study.

Background and study aims Growing emphasis on quality and patient safety has supported the shift toward competency-based medical education for advanced endoscopy trainees (AETs). In this study, we aimed to examine Canadian AETs learning curves and achievement of competence using an ERCP assessment tool with strong evidence of validity. Methods This prospective study was conducted at five institutions across Canada from 2017-2018. Data on every fifth procedure performed by trainees were collected using the United Kingdom Joint Advisory Joint Advisory Group of Gastrointestinal Endoscopy (JAG) ERCP Direct Observation of Procedural Skills (DOPS) tool, which includes a four-point rating scale for 27 items. Cumulative sum (CUSUM) analysis was used to create learning curves for overall supervision ratings and ERCP DOPS items by plotting scores for procedures performed during training. Results Eleven trainees who were evaluated for 261 procedures comprised our sample. The median number of evaluations by site was 49 (Interquartile range (IQR) 31-76) and by trainee was 15 (IQR 11-45). The overall cannulation rate by trainees was 82 % (241/261), and the native papilla cannulation rate was 78 % (149/191). All trainees achieved competence in the "overall supervision" domain of the ERCP DOPS by the end of their fellowship. Trainees achieved competency in all individual domains, except for tissue sampling and sphincteroplasty. Conclusions Canadian AETs are graduating from fellowship programs with acceptable levels of competence for overall ERCP performance and for the most specific tasks. Learning curves may help identify areas of deficiency that may require supplementary training, such as tissue sampling.

Geographic and Socioeconomic Disparity of Gastric Cancer Patients in Canada.

Gastric cancer is the 5th most common malignancy worldwide, representing ~5-10% of all new cancer cases. Although its incidence is declining, it is estimated that 1 in 98 Canadians will develop gastric cancer in their lifetime. The epidemiology and distribution of gastric cancer throughout Canada, however, remains poorly understood. A retrospective analysis of demographic data across Canada between 1992 and 2010 was performed using 2 population-based cancer registries. The incidence of gastric cancer was examined at the levels of provinces, cities, and postal codes. In addition, 43,955 patients were diagnosed with gastric cancer in Canada between 1992 and 2010; 66% were male and the average age of diagnosis was 68.4 years. The age-adjusted incidence rate was 5.07 cases per 100,000 individuals per year. The incidence decreased over the study period by 30%. High incidence rates were identified in rural areas of Newfoundland and Labrador, New Brunswick, and Quebec. Our study found a significant association between gastric cancer incidence rates and lower socioeconomic status, as well as Hispanic ethnicity. This is the first study to provide a comprehensive analysis of the incidence of gastric carcinoma in Canada, identifying high-risk populations that may benefit from increased primary and secondary prevention.

Epidemiologic trends and geographic distribution of esophageal cancer in Canada: A national population-based study.

BACKGROUND: Esophageal cancer can be subdivided into two main histological subtypes with significant variability in their etiology and epidemiology. The incidence of esophageal adenocarcinoma (AC) is increasing across the developed countries, whereas the incidence of esophageal squamous cell carcinoma (SCC) is declining. Several risk factors have been identified in the pathogenesis of each subtype, however, their epidemiologic characteristics and distribution throughout Canada remain poorly understood. METHODS: We performed a retrospective analysis of demographic data across Canada from 1992 to 2010 using two independent population-based cancer registries. The incidence of esophageal cancer, for each subtype, was examined at the levels of provinces/territories, cities, and postal codes. RESULTS: A total of 19 790 patients were diagnosed with esophageal cancer in Canada between 1992 and 2010; 74% were males. The average national incidence rate was 33.5 cases per million individuals per year. Incidence of esophageal AC increased over time, with notable high-incidence rates on the Vancouver Island, the coasts of the Great Lakes, and the coasts of the Northumberland Strait in the Maritimes. The overall incidence of esophageal SCC has decreased. However, high incidence of esophageal SCC was detected in the Vancouver city, rural eastern Québec, and in the Maritimes. We also report clustering for each subtype using postal codes, which sheds light onto new avenues of research for potential environmental etiologies. CONCLUSIONS: This study, for the first time, provides a detailed analysis on the burden of esophageal cancer in Canada, revealing important geographic clustering trends.

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.

2017 Canadian Association of Gastroenterology Educational Needs Assessment Report.

The annual survey of Canadian Association of Gastroenterology (CAG) members' educational needs was conducted via an online survey sent to 772 CAG members in March 2017. A total of 211 individuals responded to the survey, of which 197 went on to rate educational topics. Similar to previous years, endoscopy techniques, Crohn's & Ulcerative Colitis, and Inflammatory Bowel Disease (IBD) topics were most in demand for future educational events. Other highly rated areas were celiac disease, functional bowel disorders (IBS), GI oncology, non-IBD intestinal disorders, upper GI bleeding, nutrition, NAFLD, and chronic diarrhea.

Training the gastrointestinal endoscopy trainer.

Endoscopy training has traditionally been accomplished by an informal process in the endoscopy unit that parallels apprenticeship training seen in other areas of professional education. Subsequent to an audit, a series of interventions were implemented in the English National Health Service to support both service delivery and to improve endoscopy training. The resulting training centers deliver a variety of hands-on endoscopy courses, established in parallel with the roll out of a colon cancer screening program that monitors and documents quality outcomes among endoscopists. The program developed a 'training the trainer' module that subsequently became known as the Training the Colonoscopy Trainer course (TCT). Several years after its implementation, colonoscopy quality outcomes in the UK have improved substantially. The core TCT program has spread to other countries with demonstration of a marked impact on endoscopy training and performance. The aim of this chapter is to describe the principles that underlie effective endoscopy training in this program using the TCT as an example. While the review focuses on the specific example of colonoscopy training, the approach is generic to the teaching of any technical skill; it has been successfully transferred to the teaching of laparoscopic surgery as well as other endoscopic techniques.