Nonendoscopic Screening for Barrett's Esophagus and Esophageal Adenocarcinoma in At-Risk Veterans.

INTRODUCTION: Although rates of esophageal adenocarcinoma (EAC) in the United States continue to rise, many patients at risk of disease are not screened. EsoCheck (EC), a nonendoscopic esophageal balloon sampling device coupled with EsoGuard (EG), a DNA-based screening assay, is an US Food and Drug Administration-approved minimally invasive alternative to the traditional screening method of upper endoscopy. The objective of this study was to prospectively determine the diagnostic accuracy, tolerance, and acceptability of the EC/EG test in a screening population. METHODS: We recruited veterans who met the American College of Gastroenterology Guideline criteria for endoscopic Barrett's esophagus (BE) and EAC screening at the Louis Stokes Cleveland Veterans Affairs Medical Center. All study participants completed unsedated EC-guided distal esophageal sampling followed by a sedated esophagogastroduodenoscopy (EGD). Diagnostic yield of the EG assay and EGD was recorded and used in calculation of sensitivity and specificity of EC/EG in prospective screening. The abbreviated Spielberger State-Trait Anxiety Inventory questionnaire was administered before and after completion of EC. Overall tolerance of EC sampling was evaluated on a 10-point Likert scale. RESULTS: Esophageal cancer screening was accepted by 130 of 782 eligible veterans (16.6%), and we analyzed results of those who completed both screening tests (N = 124). Prevalence of BE/EAC among studied veterans was 12.9% (16/124), based on EGD. Sensitivity and specificity of EC/EG for EGD-detected BE/EAC were 92.9% (95% confidence interval [CI] 66.1-99.8) and 72.2% (95% CI 62.1-80.8), respectively. Positive and negative predictive values were 32.5% (95% CI 18.6-49.1) and 98.6% (95% CI 92.4-100), respectively. Baseline Spielberger State-Trait Anxiety Inventory-6 scores were reflective of notable levels of anxiety among veterans in the periprocedural setting. The mean postprocedure acceptability score for the EC test was 7.23 (SD 2.45). DISCUSSION: Our data suggest excellent sensitivity and negative predictive value of EC/EG in a screening population of veterans, making this modality a powerful screening tool for BE and EAC.

Multicenter, Prospective Trial of Nonendoscopic Biomarker-Driven Detection of Barrett's Esophagus and Esophageal Adenocarcinoma.

INTRODUCTION: Preliminary data suggest that an encapsulated balloon (EsoCheck), coupled with a 2 methylated DNA biomarker panel (EsoGuard), detects Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC) with high accuracy. The initial assay requires sample freezing upon collection. The purpose of this study was to assess a next-generation EsoCheck sampling device and EsoGuard assay in a much-enlarged multicenter study clinically enhanced by using a Clinical Laboratory Improvement Amendments of 1988-compliant assay and samples maintained at room temperature. METHODS: Cases with nondysplastic BE (NDBE), dysplastic BE (indefinite for dysplasia, low-grade dysplasia, high-grade dysplasia), EAC, junctional adenocarcinoma, plus endoscopy controls without esophageal intestinal metaplasia, were prospectively enrolled. Medical assistants at 6 institutions delivered the encapsulated balloon per orally with inflation in the stomach. The inflated balloon sampled the distal 5 cm of the esophagus and then was deflated and retracted into the capsule, preventing sample contamination. EsoGuard bisulfite sequencing assayed levels of methylated vimentin and methylated cyclin A1. RESULTS: A total of 243 evaluable patients-88 cases (median age 68 years, 78% men, 92% White) and 155 controls (median age 57 years, 41% men, 88% White)-underwent adequate EsoCheck sampling. The mean procedural time was approximately 3 minutes. Cases included 31 with NDBE, 16 with indefinite for dysplasia/low-grade dysplasia, 23 with high-grade dysplasia, and 18 with EAC/junctional adenocarcinoma. Thirty-seven NDBE and dysplastic BE cases (53%) were short-segment BE (<3 cm). Overall sensitivity was 85% (95% confidence interval 0.78-0.93) and specificity was 85% (95% confidence interval 0.79-0.90). Sensitivity for NDBE was 84%. EsoCheck/EsoGuard detected 100% of cancers (n = 18). DISCUSSION: EsoCheck/EsoGuard demonstrated high sensitivity and specificity in detecting BE and BE-related neoplasia.

EUS-guided coil injection therapy in the management of gastric varices: the first U.S. multicenter experience (with video).

BACKGROUND AND AIMS: Despite the significant morbidity associated with gastric variceal bleeding, there is a paucity of high-quality data regarding optimal management. EUS-guided coil injection therapy (EUS-COIL) has recently emerged as a promising endoscopic modality for the treatment of gastric varices (GV), particularly compared with traditional direct endoscopic glue injection. Although there are data on the feasibility and safety of EUS-COIL in the management of GV, these have been limited to select centers with particular expertise. The aim of this study was to report the first U.S. multicenter experience of EUS-COIL for the management of GV. METHODS: This retrospective analysis included patients with bleeding GV or GV at risk of bleeding who underwent EUS-COIL at 10 U.S. tertiary care centers between 2018 and 2022. Baseline patient and procedure-related information was obtained. EUS-COIL entailed the injection of .018 inch or .035 inch hemostatic coils using a 22-gauge or 19-gauge FNA needle. Primary outcomes were technical success (defined as successful deployment of coil into varix under EUS guidance with diminution of Doppler flow), clinical success (defined as cessation of bleeding if present and/or absence of bleeding at 30 days' postintervention), and intraprocedural and postprocedural adverse events. RESULTS: A total of 106 patients were included (mean age 60.4 ± 12.8 years; 41.5% female). The most common etiology of GV was cirrhosis (71.7%), with alcohol being the most common cause (43.4%). Overall, 71.7% presented with acute GV bleeding requiring intensive care unit stay and/or blood transfusion. The most common GV encountered were isolated GV type 1 (60.4%). A mean of 3.8 ± 3 coils were injected with a total mean length of 44.7 ± 46.1 cm. Adjunctive glue or absorbable gelatin sponge was injected in 82% of patients. Technical success and clinical success were 100% and 88.7%, respectively. Intraprocedural adverse events (pulmonary embolism and GV bleeding from FNA needle access) occurred in 2 patients (1.8%), and postprocedural adverse events occurred in 5 (4.7%), of which 3 were mild. Recurrent bleeding was observed in 15 patients (14.1%) at a mean of 32 days. Eighty percent of patients with recurrent bleeding were successfully re-treated with repeat EUS-COIL. No significant differences were observed in outcomes between high-volume (>15 cases) and low-volume (<7 cases) centers. CONCLUSIONS: This U.S. multicenter experience on EUS-COIL for GV confirms high technical and clinical success with low adverse events. No significant differences were seen between high- and low-volume centers. Repeat EUS-COIL seems to be an effective rescue option for patients with recurrent bleeding GV. Further prospective studies should compare this modality versus other interventions commonly used for GV.

Patients With Esophageal Adenocarcinoma With Prior Gastroesophageal Reflux Disease Symptoms Are Similar to Those Without Gastroesophageal Reflux Disease: A Cross-Sectional Study.

INTRODUCTION: A substantial proportion of patients with esophageal adenocarcinoma (EAC) do not report gastroesophageal reflux disease (GERD) symptoms. This study aimed to compare the risk factor profiles and cancer stage at presentation of patients with EAC with and without prior GERD. METHODS: In this retrospective cross-sectional study, patients with EAC were divided into 2 cohorts: (i) EAC with prior GERD: patients who reported typical GERD symptoms (heartburn or regurgitation) ≥1 year before cancer diagnosis and (ii) EAC without prior GERD: patients who did not report prior GERD symptoms or reported symptoms within 1 year of their cancer diagnosis. Baseline demographics, risk factors, and cancer stage at presentation were compared between the 2 cohorts. In addition, the distribution of patients based on numbers of BE/EAC-associated risk factors (1, 2, 3, 4, and 5 or more) was examined in the symptomatic and asymptomatic cohorts. RESULTS: Over 13 years, 388 patients with EAC with prior GERD and 245 patients with EAC without prior GERD were recruited. Both groups had similar baseline demographics and risk factors, but patients with EAC with prior GERD were more likely to have a history of BE. Asymptomatic patients had more advanced disease. Patients with 3 or more BE/EAC-related risk factors formed the largest proportion of patients in both the symptomatic and asymptomatic cohorts. DISCUSSION: Patients with EAC with and without prior GERD symptoms are phenotypically similar, suggesting that BE screening efforts to prevent or detect early EAC should not be restricted to just those with GERD.

Impact of withdrawal time on adenoma detection rate: results from a prospective multicenter trial.

BACKGROUND AND AIMS: Performing a high-quality colonoscopy is critical for optimizing the adenoma detection rate (ADR). Colonoscopy withdrawal time (a surrogate measure) of ≥6 minutes is recommended; however, a threshold of a high-quality withdrawal and its impact on ADR are not known. METHODS: We examined withdrawal time (excluding polyp resection and bowel cleaning time) of subjects undergoing screening and/or surveillance colonoscopy in a prospective, multicenter, randomized controlled trial. We examined the relationship of withdrawal time in 1-minute increments on ADR and reported odds ratio (OR) with 95% confidence intervals. Linear regression analysis was performed to assess the maximal inspection time threshold that impacts the ADR. RESULTS: A total of 1142 subjects (age, 62.3 ± 8.9 years; 80.5% men) underwent screening (45.9%) or surveillance (53.6%) colonoscopy. The screening group had a median withdrawal time of 9.0 minutes (interquartile range [IQR], 3.3) with an ADR of 49.6%, whereas the surveillance group had a median withdrawal time of 9.3 minutes (IQR, 4.3) with an ADR of 63.9%. ADR correspondingly increased for a withdrawal time of 6 minutes to 13 minutes, beyond which ADR did not increase (50.4% vs 76.6%, P < .01). For every 1-minute increase in withdrawal time, there was 6% higher odds of detecting an additional subject with an adenoma (OR, 1.06; 95% confidence interval, 1.02-1.10; P = .004). CONCLUSIONS: Results from this multicenter, randomized controlled trial underscore the importance of a high-quality examination and efforts required to achieve this with an incremental yield in ADR based on withdrawal time. (Clinical trial registration number: NCT03952611.).

Evidence-Based Cognitive Endoscopy Simulators: Do They Exist? A Systematic Search and Evaluation of Existing Platforms.

BACKGROUND: The development of guidelines by gastroenterology societies increasingly stresses evidence-based endoscopic practice. AIMS: We performed a systematic assessment to determine whether endoscopic video teaching platforms incorporate evidence-based educational strategies and methods in order to disseminate guideline-based endoscopic management strategies. METHODS: Platforms with a video component were systematically identified using the Google search engine, Apple and Android application stores, and searching four major gastroenterology society websites and three known platforms, to identify all relevant platforms. Two video samples from each teaching platform were reviewed independently by two authors and assessed for use of a priori defined principles of evidence-based medicine, as determined by consensus agreement and for the use of simulation. RESULTS: Fourteen platforms were included in the final analysis, and two videos from each were analyzed. One of the 14 platforms used simulation and incorporated evidence-based medicine principles consistently. Nine of the 14 platforms were not transparent in regard to citation. None of the platforms consistently cited the certainty of evidence or explained how evidence was selected. CONCLUSIONS: Education of guideline-based endoscopic management strategies using principles of evidence-based medicine is under-utilized in endoscopic videos. In addition, the use of cognitive simulation is absent in this arena. There is a paucity of evidence-based cognitive endoscopy simulators designed for fellows that incorporate systematic evaluation, and efforts should be made to create this platform.

Meet EBE: The Development of an Evidence-Based Endoscopy Simulator.

BACKGROUND AND AIMS: In the digital era of evidence-based medicine, there is a paucity of video endoscopy teaching platforms that use evidence-based medicine principles, or that allow for cognitive simulation of endoscopic management strategies. We created a guideline-based teaching platform for fellows that incorporates these features, and tested it. METHODS: A pilot video module with embedded questions was drafted, and after incorporation of feedback from several attending gastroenterologists, an additional 2 modules were created. The embedded questions were designed to simulate cognitive management decisions as if the viewer were doing the endoscopy procedure in the video. A narrator explained the evidence behind the task being performed, and its certainty based on endoscopic guidelines. Quizzes and surveys were developed and administered to a sample of attendings and fellows who completed the video modules to test efficacy, usability, and likeability. RESULTS: Three video modules, named evidence-based endoscopy (EBE), incorporating low fidelity simulation, and utilizing evidence-based medicine principles, were created. Eight fellows and 10 attendings completed the video modules and all quizzes and surveys. Mean test scores improved from before to after completing the video modules (56% to 92%; mean difference = -35%; 95% confidence interval, 27%-47%). Surveys indicated that the product was viewed favorably by participants, and that there is a strong desire for this type of educational product. CONCLUSIONS: The EBE simulator is a unique, desirable, and effective educational platform based on evidence-based medicine principles that fills a gap in available tools for endoscopy education. Further studies are needed to assess whether EBE can aid in long-term knowledge retention and increase adherence to guideline recommendations.

Massively Parallel Sequencing of Esophageal Brushings Enables an Aneuploidy-Based Classification of Patients With Barrett's Esophagus.

BACKGROUND & AIMS: Aneuploidy has been proposed as a tool to assess progression in patients with Barrett's esophagus (BE), but has heretofore required multiple biopsies. We assessed whether a single esophageal brushing that widely sampled the esophagus could be combined with massively parallel sequencing to characterize aneuploidy and identify patients with disease progression to dysplasia or cancer. METHODS: Esophageal brushings were obtained from patients without BE, with non-dysplastic BE (NDBE), low-grade dysplasia (LGD), high-grade dysplasia (HGD), or adenocarcinoma (EAC). To assess aneuploidy, we used RealSeqS, a technique that uses a single primer pair to interrogate ∼350,000 genome-spanning regions and identify specific chromosome arm alterations. A classifier to distinguish NDBE from EAC was trained on results from 79 patients. An independent validation cohort of 268 subjects was used to test the classifier at distinguishing patients at successive phases of BE progression. RESULTS: Aneuploidy progression was associated with gains of 1q, 12p, and 20q and losses on 9p and 17p. The entire chromosome 8q was often gained in NDBE, whereas focal gain of 8q24 was identified only when there was dysplasia. Among validation subjects, a classifier incorporating these features with a global measure of aneuploidy scored positive in 96% of EAC, 68% of HGD, but only 7% of NDBE. CONCLUSIONS: RealSeqS analysis of esophageal brushings provides a practical and sensitive method to determine aneuploidy in BE patients. It identifies specific chromosome changes that occur early in NDBE and others that occur late and mark progression to dysplasia. The clinical implications of this approach can now be tested in prospective trials.

High-Definition Colonoscopy Compared With Cuff- and Cap-Assisted Colonoscopy: Results From a Multicenter, Prospective, Randomized Controlled Trial.

BACKGROUND AND AIMS: Mucosal exposure devices including distal attachments such as the cuff and cap have shown variable results in improving adenoma detection rate (ADR) compared with high-definition white light colonoscopy (HDWLE). METHODS: We performed a prospective, multicenter randomized controlled trial in patients undergoing screening or surveillance colonoscopy comparing HDWLE to 2 different types of distal attachments: cuff (CF) (Endocuff Vision) or cap (CP) (Reveal). The primary outcome was ADR. Secondary outcomes included adenomas per colonoscopy, advanced adenoma and sessile serrated lesion detection rate, right-sided ADR, withdrawal time, and adverse events. Continuous variables were compared using Student's t test and categorical variables were compared using chi-square or Fisher's exact test using statistical software Stata version16. A P value <.05 was considered significant. RESULTS: A total of 1203 subjects were randomized to either HDWLE (n = 384; mean 62 years of age; 81.3% males), CF (n = 379; mean 62.7 years of age; 79.9% males) or CP (n = 379; mean age 62.1 years of age; 80.5% males). No significant differences were found among 3 groups for ADR (57.3%, 59.1%, and 55.7%; P = .6), adenomas per colonoscopy (1.4 ± 1.9, 1.6 ± 2.4, and 1.4 ± 2; P = .3), advanced adenoma (7.6%, 9.2%, and 8.2%; P = .7), sessile serrated lesion (6.8%, 6.3%, and 5.5%; P = .8), or right ADR (48.2%, 49.3%, and 46.2%; P = .7). The number of polyps per colonoscopy were significantly higher in the CF group compared with HDWLE and CP group (2.7 ± 3.4, 2.3 ± 2.5, and 2.2 ± 2.3; P = .013). In a multivariable model, after adjusting for age, sex, body mass index, withdrawal time, and Boston Bowel Preparation Scale score, there was no impact of device type on the primary outcome of ADR (P = .77). In screening patients, CF resulted in more neoplasms per colonoscopy (CF: 1.7 ± 2.6, HDWLE: 1.3 ± 1.7, and CP: 1.2 ± 1.8; P = .047) with a shorter withdrawal time. CONCLUSIONS: Results from this multicenter randomized controlled trial do not show any significant benefit of using either distal attachment devices (CF or CP) over HDWLE, at least in high-detector endoscopists. The Endocuff may have an advantage in the screening population. (ClinicalTrials.gov, Number: NCT03952611).

Cold versus hot endoscopic mucosal resection for large sessile colon polyps: a cost-effectiveness analysis.

BACKGROUND : For large sessile colorectal polyps (LSCPs), endoscopic mucosal resection without diathermy ("cold endoscopic mucosal resection [EMR]") is gaining popularity because of its safety advantages over conventional EMR ("hot EMR"). Polyp recurrence rates have been reported to be higher with cold EMR. Considering these differences, we performed a cost-effectiveness analysis of these two techniques. METHODS : A decision analysis model was constructed for EMR of an LSCP. The decision tree incorporated the EMR method, clip use, procedural mortality, adverse events and their management, and polyp recurrence. Outcomes included days of lost productivity and marginal cost difference. Adverse event and recurrence rates were extracted from the existing literature, giving emphasis to recent systematic reviews and randomized controlled trials. RESULTS : Through 30 months of follow-up, the average cost of removing an LSCP by cold EMR was US$5213, as compared to $6168 by hot EMR, yielding a $955 cost difference (95 % confidence interval $903-$1006). Average days of lost productivity were 6.2 days for cold EMR and 6.3 days for hot EMR. This cost advantage remained over several analyses accounting for variations in recurrence rates and clip closure strategies. Clip cost and LSCP recurrence rate had the greatest and the least impacts on the marginal cost difference, respectively. CONCLUSION : Cold EMR is the dominant strategy over hot EMR, with lower cost and fewer days of lost productivity. In theory, a complete transition to cold EMR for LSCPs in the USA could result in an annual cost saving approaching US$7 million to Medicare beneficiaries.

AGA Clinical Practice Update on the Optimal Management of the Malignant Alimentary Tract Obstruction: Expert Review.

BACKGROUND & AIMS: The purpose of this expert review is to describe the current methodologies available to manage malignant alimentary tract obstructions as well the evidence behind the various methods (including their efficacy and safety), indications, and appropriate timing of interventions. METHODS: This is not a formal systematic review but is based on a review of the literature to provide best practice advice statements. No formal rating of the quality of evidence or strength of recommendation is carried out. BEST PRACTICE ADVICE 1: For all patients with alimentary tract obstruction, the decision about specific interventions should be made in a multidisciplinary setting including oncologists, surgeons, and endoscopists and take into account the characteristics of the obstruction, patient's expectations, prognosis, expected subsequent therapies, and functional status. BEST PRACTICE ADVICE 2: For patients who present with esophageal obstruction from esophageal cancer and who are potential candidates for resection or chemoradiation, clinicians should not routinely insert a self-expanding metal stent (SEMS) without multidisciplinary review because of high rates of stent migration, higher morbidity and mortality, and potentially lower R0 (microscopically negative margins) resection rates. BEST PRACTICE ADVICE 3: For patients who present with esophageal obstruction from esophageal cancer who are potential candidates for resection and who have concerns of malnutrition, clinicians may consider the use of enteral feeding tubes (via nasogastric or percutaneous route). Clinicians should be aware of the potential risk of abdominal wall tumor seeding as well as making subsequent gastric conduit formation difficult with percutaneous endoscopic gastrostomy placement. BEST PRACTICE ADVICE 4: For patients who present with esophageal obstruction from esophageal cancer who are not candidates for resection, clinicians should consider either SEMS insertion or brachytherapy as sole therapy or in combination. Clinicians should not consider the use of laser therapy or photodynamic therapy because of the lack of evidence of better outcomes and superior alternatives. BEST PRACTICE ADVICE 5: For patients with malignant esophageal obstruction who are undergoing SEMS placement, clinicians should use a fully covered or partially covered SEMS and not an uncovered SEMS, with consideration of a stent-anchoring/fixation method. BEST PRACTICE ADVICE 6: For patients with gastric outlet obstruction who have a life expectancy greater than 2 months, have good functional status, and who are surgically fit, surgical gastrojejunostomy should be considered. BEST PRACTICE ADVICE 7: For patients with gastric outlet obstruction who are undergoing surgical gastrojejunostomy, a laparoscopic approach is favored over an open approach because of lower blood loss and shorter hospital stay. BEST PRACTICE ADVICE 8: For patients with gastric outlet obstruction who are not candidates for gastrojejunostomy (surgical or endoscopic ultrasound-guided), clinicians should consider the insertion of an enteral stent. BEST PRACTICE ADVICE 9: Enteral stents should not be used in patients with multiple luminal obstructions or severely impaired gastric motility because of the limited benefit in these scenarios. Clinicians can consider placement of a venting gastrostomy in these patients. BEST PRACTICE ADVICE 10: Depending on the experience of the endoscopist, endoscopic ultrasound-guided gastrojejunostomy is an acceptable alternative to surgical gastrojejunostomy and enteral stent placement. Clinicians should be aware that there are currently no dedicated Food and Drug Administration-approved devices for endoscopic ultrasound-guided gastrojejunostomy. BEST PRACTICE ADVICE 11: For patients with malignant colonic obstruction who are candidates for resection, insertion of SEMS is a reasonable choice as a "bridge to surgery" to allow for one-stage, elective resection. BEST PRACTICE ADVICE 12: For patients with malignant colonic obstruction who are not candidates for resection, either SEMS placement or a diverting colostomy are reasonable choices depending on the patient's goals and functional status. BEST PRACTICE ADVICE 13: SEMS is a reasonable option for patients with proximal (or right-sided) malignant obstructions, both as a "bridge to surgery" and in the palliative setting. BEST PRACTICE ADVICE 14: SEMS placement is a reasonable alternative for patients with extracolonic malignancy who are not candidates for surgery, although their placement is more technically challenging, clinical success rates are more variable, and complications (including stent migration) are more frequent.

Management of Postcholecystectomy Biliary Complications: A Narrative Review.

Every year approximately 750,000 cholecystectomies are performed in the United States, most of those are performed laparoscopically. Postcholecystectomy complications are not uncommon and lead to increased morbidity and financial burden. Some of the most commonly encountered complications with laparoscopic cholecystectomy include biliary injury (0.08%-0.5%), bile leak (0.42%-1.1%), retained common bile duct stones (0.8%-5.7%), postcholecystectomy syndrome (10%-15%), and postcholecystectomy diarrhea (5%-12%). Endoscopy has an important role in the diagnosis and management of biliary complications and in many cases can provide definitive management. There is no consensus on the best therapeutic approach for biliary complications. Therefore, biliary complications should be approached by an experienced multidisciplinary team. It is important for the gastroenterologist to be familiar with the management of such complications (Visual Abstract, Supplemental Digital content 1, http://links.lww.com/AJG/B544).

A Prospective Multicenter Study Evaluating Learning Curves and Competence in Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography Among Advanced Endoscopy Trainees: The Rapid Assessment of Trainee Endoscopy Skills Study.

BACKGROUND & AIMS: On the basis of the Next Accreditation System, trainee assessment should occur on a continuous basis with individualized feedback. We aimed to validate endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) learning curves among advanced endoscopy trainees (AETs) by using a large national sample of training programs and to develop a centralized database that allows assessment of performance in relation to peers. METHODS: ASGE recognized training programs were invited to participate, and AETs were graded on ERCP and EUS exams by using a validated competency assessment tool that assesses technical and cognitive competence in a continuous fashion. Grading for each skill was done by using a 4-point scoring system, and a comprehensive data collection and reporting system was built to create learning curves by using cumulative sum analysis. Individual results and benchmarking to peers were shared with AETs and trainers quarterly. RESULTS: Of the 62 programs invited, 20 programs and 22 AETs participated in this study. At the end of training, median number of EUS and ERCP performed/AET was 300 (range, 155-650) and 350 (125-500), respectively. Overall, 3786 exams were graded (EUS, 1137; ERCP-biliary, 2280; ERCP-pancreatic, 369). Learning curves for individual end points and overall technical/cognitive aspects in EUS and ERCP demonstrated substantial variability and were successfully shared with all programs. The majority of trainees achieved overall technical (EUS, 82%; ERCP, 60%) and cognitive (EUS, 76%; ERCP, 100%) competence at conclusion of training. CONCLUSIONS: These results demonstrate the feasibility of establishing a centralized database to report individualized learning curves and confirm the substantial variability in time to achieve competence among AETs in EUS and ERCP. ClinicalTrials.gov: NCT02509416.

Variation in Aptitude of Trainees in Endoscopic Ultrasonography, Based on Cumulative Sum Analysis.

BACKGROUND & AIMS: Studies have reported substantial variation in the competency of advanced endoscopy trainees, indicating a need for more supervised training in endoscopic ultrasound (EUS). We used a standardized, validated, data collection tool to evaluate learning curves and measure competency in EUS among trainees at multiple centers. METHODS: In a prospective study performed at 15 centers, 17 trainees with no prior EUS experience were evaluated by experienced attending endosonographers at the 25th and then every 10th upper EUS examination, over a 12-month training period. A standardized data collection form was used (using a 5-point scoring system) to grade the EUS examination. Cumulative sum analysis was applied to produce a learning curve for each trainee; it tracked the overall performance based on median scores at different stations and also at each station. Competency was defined by a median score of 1, with acceptable and unacceptable failure rates of 10% and 20%, respectively. RESULTS: Twelve trainees were included in the final analysis. Each of the trainees performed 265 to 540 EUS examinations (total, 4257 examinations). There was a large amount of variation in their learning curves: 2 trainees crossed the threshold for acceptable performance (at cases 225 and 245), 2 trainees had a trend toward acceptable performance (after 289 and 355 cases) but required continued observation, and 8 trainees needed additional training and observation. Similar results were observed at individual stations. CONCLUSIONS: A specific case load does not ensure competency in EUS; 225 cases should be considered the minimum caseload for training because we found that no trainee achieved competency before this point. Ongoing training should be provided for trainees until competency is confirmed using objective measures.

The role of endoscopy in the management of GERD.

We recommend that uncomplicated GERD be diagnosed on the basis of typical symptoms without the use of diagnostic testing, including EGD. We recommend EGD for patients who have symptoms suggesting complicated GERD or alarm symptoms. We recommend that EGD not be routinely performed solely for the assessment of extraesophageal GERD symptoms. We recommend that endoscopic findings of reflux esophagitis be classified according to an accepted grading scale or described in detail. We suggest that repeat EGD be performed in patients with severe erosive esophagitis after at least an 8-week course of PPI therapy to exclude underlying BE or dysplasia. 44BB We recommend against obtaining tissue samples from endoscopically normal tissue to diagnose GERD or exclude BE in adults. We suggest that endoscopy be considered in patients with multiple risk factors for Barrett's esophagus. We recommend that tissue samples be obtained to confirm endoscopically suspected Barrett's esophagus. We suggest that endoscopic antireflux therapy be considered for selected patients with uncomplicated GERD after careful discussion with the patient regarding potential adverse effects, benefits, and other available therapeutic options.

Open-access endoscopy.

OAE is commonly used. The majority of patients referred for OAE are considered appropriate for endoscopy according to ASGE guidelines. Most patients undergoing OAE procedures are knowledgeable about the study and are satisfied with the experience. Several potential problems have been identified, including inappropriate referrals, communication errors, and inadequately prepared or informed patients. OAE can be safely used if preprocedure assessment, informed consent, information transfer, patient safety, and satisfaction are addressed in all cases.

Development of a program to train physician extenders to perform transnasal esophagoscopy and screen for Barrett's esophagus.

BACKGROUND & AIMS: Screening for Barrett's esophagus (BE) and esophageal adenocarcinoma is not recommended because it was not found to be cost effective. However, physician extenders (PEs) are able to perform unsedated procedures; their involvement might reduce the costs of BE screening. We examined the feasibility of training PEs to independently perform transnasal esophagoscopy (TNE) and screen patients for BE and measured their learning curve. METHODS: Two PEs at a Veterans Affairs (VA) medical center underwent a structured didactic training program and observed nasopharyngoscopies before performing TNE under the supervision of attending endoscopists. Individual technical and cognitive components of TNE were rated on a 9-point structured scale. Learning curves were constructed using cumulative summation. Once the PEs were judged to be technically competent, each PE performed 10 independent videotaped TNEs, which were graded. RESULTS: Both PEs identified anatomic landmarks after 18 consecutive procedures. PE1 and PE2 performed satisfactory nasal intubations after 20 and 25 procedures and esophageal intubations after 29 and 35 procedures, respectively. They acquired overall competence after supervised training on 43 and 47 procedures, respectively. CONCLUSIONS: We developed a program at a VA medical center to train PEs to perform TNE to screen for BE. The PEs were able to perform TNE and recognize esophageal landmarks independently after a modest number of supervised procedures.

Comparative acceptability of transnasal esophagoscopy and esophageal capsule esophagoscopy: a randomized, controlled trial in veterans.

BACKGROUND: EGD screening for Barrett's esophagus (BE) is costly, with insufficient evidence to support its effectiveness. OBJECTIVE: To compare acceptance and tolerability of 2 novel, office-based, endoscopic screening techniques done on nonsedated patients. DESIGN: Randomized block study design with allocation concealment. SETTING: Outpatient clinic setting at a Veterans Affairs medical center. PATIENTS: A total of 184 veterans with or without GERD symptoms. INTERVENTIONS: Transnasal esophagoscopy (TNE) or esophageal capsule esophagoscopy (ECE). MAIN OUTCOME MEASUREMENTS: Acceptance and tolerability of TNE and ECE and effectiveness of BE screening. RESULTS: Esophageal screening was accepted by 184 of 1210 (15.2%) veterans. The majority were men (96%) and African American (58%), with a mean (± standard deviation) age of 58.9 (± 8.1) years. Five TNE participants (5%) and 2 ECE participants (2%) refused the assigned procedure after randomization (P = .25). Eleven patients (12.6%) randomized to TNE crossed the minimal clinically important threshold for overall procedure tolerability, as opposed to no patients randomized to ECE (P = .001). Effectiveness of BE screening was not significantly different in both procedures (TNE vs ECE = 3.2% vs 5.4%; P = .47). Overall, BE was present in 8 of 75 white participants (10.6%) and in 0 of 107 African American participants (P < .001). LIMITATIONS: The general veteran population may not reflect the screening population for BE. CONCLUSION: Despite a small proportion of veterans expressing interest in esophageal screening, both TNE and ECE were feasible in the outpatient clinic setting and were accepted by >95% of participants who did express an interest. Screening was effective only in white participants. Moderate differences in tolerability between TNE and ECE notwithstanding, cost considerations along with availability of equipment and trained personnel should guide the modality to be used for BE screening.

The Bethesda ERCP Skills Assessment Tool (BESAT) can reliably differentiate endoscopists of different experience levels.

Background and study aims The Bethesda ERCP Skill Assessment Tool (BESAT) is a video-based assessment tool of technical endoscopic retrograde cholangiopancreatography (ERCP) skill with previously established validity evidence. We aimed to assess the discriminative validity of the BESAT in differentiating ERCP skill levels. Methods Twelve experienced ERCP practitioners from tertiary academic centers were asked to blindly rate 43 ERCP videos using the BESAT. ERCP videos consisted of native biliary cannulation and sphincterotomy and were recorded from 10 unique endoscopists of various ERCP experience (from advanced endoscopy fellow to > 10 years of ERCP experience). Inter-rater reliability, discriminative validity, and internal structure validity were subsequently assessed. Results The BESAT was found to reliably differentiate between endoscopists of varying levels of ERCP experience with experienced ERCPists scoring higher than novice ERCPists in 11 of 13 (85%) instrument items. Inter-rater reliability for BESAT items ranged from good to excellent (intraclass correlation range: 0.86 to 0.93). Internal structure validity was assessed with item-total correlations ranging from 0.53 to 0.83. Conclusions Study findings demonstrate that the BESAT, a video-based ERCP skill assessment tool, has high inter-rater reliability and has discriminative validity in differentiating novice from expert ERCP skill. Further investigations are needed to determine the role of video-based assessment in improving trainee learning curves and patient outcomes.