Varied Trainee Competence in Cold Snare Polypectomy: Results of the COMPLETE Randomized Controlled Trial.

INTRODUCTION: Cold snare polypectomy (CSP) is strongly recommended as the optimal technique for the complete removal of small polyps. Though significant variability in polypectomy technique and quality has been established, the learning curve and impact of targeted training on CSP are unknown. Video feedback has shown promise as an effective pedagogy to improve performance among surgical trainees. We aimed to compare CSP performance between trainees who received video-based feedback and those who received conventional apprentice-based concurrent feedback. We hypothesized that video-based feedback would accelerate competence. METHODS: We conducted a single-blinded, randomized controlled trial on competence for CSP of polyps <1 cm, comparing video-based feedback with conventional feedback. We randomly assigned deidentified consecutively recorded CSP videos to blinded raters to assess using the CSP Assessment Tool. We shared cumulative sum learning curves every 25 CSP with each trainee. The video feedback trainees also received biweekly individualized terminal feedback. Control trainees received conventional feedback during colonoscopy. The primary outcome was CSP competence. We also assessed competence across domains and change over polypectomy volume. RESULTS: We enrolled and randomized 22 trainees, 12 to video-based feedback and 10 to conventional feedback, and evaluated 2,339 CSP. The learning curve was long; 2 trainees (16.7%) in the video feedback achieved competence, after a mean of 135 polyps, and no one in the control ( P = 0.481) achieved competence. Overall and in all steps of CSP, a higher percentage of the video feedback group met competence, increasing 3% every 20 CSP ( P = 0.0004). DISCUSSION: Video feedback aided trainees to competence in CSP. However, the learning curve was long. Our findings strongly suggest that current training methods are not sufficient to support trainees to competency by the completion of their fellowship programs. The impact of new training methods, such as simulation-based mastery learning, should be assessed to determine whether such methods can result in achievement of competence at a faster rate; ClinicalTrials.gov : NCT03115008.

Cadaveric emergency cricothyrotomy training for non-surgeons using a bronchoscopy-enhanced curriculum.

BACKGROUND: Emergency cricothyrotomy training for non-surgeons is important as rare "cannot intubate or oxygenate events" may occur multiple times in a provider's career when surgical expertise is not immediately available. However, such training is highly variable and often infrequent, therefore, enhancing these experiences is important. RESEARCH QUESTION: Is bronchoscopy-enhanced cricothyrotomy training in cadavers feasible, and what are the potential benefits provided by this innovation for trainees? METHODS: This study was performed during implementation of a new program to train non-surgeon providers on cadaveric donors on our campus. Standard training with an instructional video and live coaching was enhanced by bronchoscopic visualization of the trachea allowing participants to review their technique after performing scalpel and Seldinger-technique procedures, and to review their colleagues' technique on live video. Feasibility was measured through assessing helpfulness for trainees, cost, setup time, quality of images, and operator needs. Footage from the bronchoscopy recordings was analyzed to assess puncture-to-tube time, safety errors, and evidence for a training effect within groups. Participants submitted pre- and post-session surveys assessing their levels of experience and gauging their confidence and anxiety with cricothyrotomies. RESULTS: The training program met feasibility criteria for low costs (<200 USD/donor), setup time (<30 minutes/donor), and operator needs (1/donor). Furthermore, all participants rated the cadaveric session as helpful. Participants demonstrated efficient technique, with a median puncture-to-tube time of 48.5 seconds. Bronchoscopy recordings from 24 analyzed videos revealed eight instances of sharp instruments puncturing the posterior tracheal wall (33% rate), and two instances of improper tube placement (8% rate). Sharp instruments reached potentially dangerous insertion depths beyond the midpoint of the anterior-posterior diameter of the trachea in 58.3% of videos. Bronchoscopic enhancement was rated as quite or extremely helpful for visualizing the trachea (83.3%) and to assess depth of instrumentation (91.7%). There was a significant average increase in confidence (64.4%, P<0.001) and average decrease in performance anxiety (-11.6%, P = 0.0328) after the session. A training effect was seem wherein the last trainee in each group had no posterior tracheal wall injuries. INTERPRETATION: Supplementing cadaveric emergent cricothyrotomy training programs with tracheal bronchoscopy is feasible, helpful to trainees, and meets prior documented times for efficient technique. Furthermore, it was successful in detecting technical errors that would have been missed in a standard training program. Bronchoscopic enhancement is a valuable addition to cricothyrotomy cadaveric training programs and may help avoid real-life complications.

Novel histologic score predicts recurrent intestinal metaplasia after successful endoscopic eradication therapy.

Endoscopic eradication therapy (EET) is an effective treatment for Barrett's esophagus (BE); however, disease recurrence remains problematic requiring surveillance post-treatment. While data regarding predictors of recurrence are limited, uncontrolled reflux may play a significant role. Our aim was to develop a scoring system based on histopathologic reflux in surveillance biopsies following EET to identify patients at high risk for recurrence of BE. Patients were identified from two centers in the treatment with resection and endoscopic ablation techniques for BE consortium. Hematoxylin and eosin-stained slides of surveillance biopsies post-EET were assessed for histologic changes associated with reflux from a cohort of patients who also underwent pH-metry (derivation cohort). We developed a novel scoring system (Recurrent Epithelial Changes from Uncontrolled Reflux [RECUR]) composed of dilated intercellular spaces, epithelial ballooning, basal cell hyperplasia, and parakeratosis, to identify patients with abnormal esophageal acid exposure. This scoring system was then used to grade surveillance biopsies from patients with or without recurrence of BE following EET (validation cohort). Of 41 patients in the derivation cohort, 19.5% had abnormal acid exposure times (AET) while on proton pump inhibitor therapy. The mean (SD) RECUR score for patients with AET <4% was 4.0 (1.6), compared with 5.5 (0.9) for AET ≥4% (P = 0.015). In the validation cohort consisting of 72 patients without recurrence and 64 patients with recurrence following EET, the RECUR score was the only significant predictor of recurrence (odds ratio: 1.36, 95% confidence interval: 1.10-1.69, P = 0.005). Histologic grading of surveillance biopsies using the RECUR scoring system correlates with BE recurrence following EET.

The accuracy of hip fracture data entered into the national surgical quality improvement program (NSQIP) database.

PURPOSE: Internal validation studies of National Surgical Quality Improvement Program (NSQIP) registry data have reported potential inaccuracies. The purpose of this study was to determine the accuracy of hip fracture CPT codes and complications entered into NSQIP for a single participating center. METHODS: A retrospective study identified patients with a hip fracture CPT code from NSQIP data at a single institution over a two-year period. CPT codes included 27235 (percutaneous fixation of femoral neck fracture (Perc FNFX)), 27236 (open treatment of femoral neck fracture, internal fixation/prosthetic replacement (Open FNFX)), 27244 (open treatment of inter/peri/subtrochanteric femoral fracture with plate (Plate ITFX)), 27245 (treatment of inter/peri/subtrochanteric femoral fracture, with intramedullary implant (IMN ITFX)), and 27125 (hemiarthroplasty (HA)). The institutional medical record was reviewed to determine the accuracy of CPT code and 30-day complication data entered into the registry. RESULT: 12.8% (n = 20/156) of patients had an inaccurate CPT code. The proportion of inaccurate CPT codes varied significantly by procedure: Plate ITFX (76.9%), Open FNFX (13.8%), IMN ITFX (7.0%), and HA (0%) (p < 0.0001). A total of 82 complications were identified in 66 patients via the medical record. 43.9% (n = 36/82) of these complications were not documented in the NSQIP data. The proportion of missing complications varied significantly by type: renal (100%), UTI (53.8%), infection (50%), bleeding (30%), death (25%), respiratory (25%), cardiac (0%), stroke (0%), and VTE (0%) (p < 0.0001). CONCLUSION: Hip fracture CPT codes and 30-day complication data entered into the NSQIP registry were frequently inaccurate. Studies incorporating NSQIP data should acknowledge these potential limitations of the registry, and future research to validate NSQIP orthopedic data across procedures and institutions is necessary. LEVEL OF EVIDENCE: LEVEL III: Diagnostic study.

Defining Sacral Dysmorphism: What Size Corridor Precludes Transsacral Screw Placement.

OBJECTIVE: To determine what size S1-transsacral (TS) corridor is amenable to TS screw placement, as this is commonly used to identify sacral dysmorphism, and to determine if gender, ethnicity, or screw breach is associated with narrow corridors. DESIGN: Retrospective review. SETTING: Urban level-1 trauma center. PATIENTS: Two hundred ninety patients with pelvic ring injuries and preoperative computed tomography (CT) scans. INTERVENTION: Percutaneous posterior pelvic ring fixation. MAIN OUTCOME MEASUREMENTS: The width of the S1-TS corridor was measured on the axial (inlet) and coronal (outlet) reformatted CT images. Patients with S1-TS screw fixation and postoperative CT scans were identified. Corridor size, gender, ethnicity, and screw breach were documented. RESULTS: S1-TS screws were placed in 55 of the 290 patients. No S1-TS screws were placed in corridors less than 8 mm. Corridors of <8 mm were present in 114 (39%) of the 290 patients and were not associated with gender or ethnicity. S1-TS screws placed in small (<10 mm) versus large (≥10 mm) corridors did not have a detectable difference in screw breaches (5 of 8, 62% versus 19 of 47 40%; difference, 22%, 95% confidence interval -14% to 52%) or median (interquartile range) screw breach distance [3 mm (2.5-4.8) versus 3 mm (1.2-4.8); difference, 0.9 mm; confidence interval -1.6 to 2.2]. CONCLUSION: These data are useful for the standardization of sacral dysmorphism reporting based on corridor size. Screw breaches were common irrespective of TS corridor size, emphasizing the small degree of error allowed by this procedure. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Threshold evaluation for optimal number of endoscopic treatment sessions to achieve complete eradication of Barrett's metaplasia.

BACKGROUND: Endoscopic eradication therapy (EET) is the standard of care for Barrett's esophagus (BE)-associated neoplasia. Previous data suggest the mean number of EET sessions required to achieve complete eradication of intestinal metaplasia (CE-IM) is 3. This study aimed to define the threshold of EET sessions required to achieve CE-IM. METHODS: The TREAT-BE Consortium is a multicenter outcomes cohort including prospectively enrolled patients with BE undergoing EET. All patients achieving CE-IM were included. Demographic, endoscopic, and histologic data were recorded at treatment onset along with treatment details and surveillance data. Kaplan-Meier analysis was performed to define a threshold of EET sessions, with 95 %CI, required to achieve CE-IM. A secondary analysis examined predictors of incomplete response to EET using multiple logistic regression and recurrence rates. RESULTS: 623 patients (mean age 65.2 [SD 11.6], 79.6 % male, 86.5 % Caucasian) achieved CE-IM in a mean of 2.9 (SD 1.7) EET sessions (median 2) and a median total observation period of 2.7 years (interquartile range 1.4-5.0). After three sessions, 73 % of patients achieved CE-IM (95 %CI 70 %-77 %). Age (odds ratio [OR] 1.25, 95 %CI 1.05-1.50) and length of BE (OR 1.24, 95 %CI 1.17-1.31) were significant predictors of incomplete response. CONCLUSION: The current study found that a threshold of three EET sessions would achieve CE-IM in the majority of patients. Alternative therapies and further diagnostic testing should be considered for patients who do not have significant response to EET after three sessions.

Using Reformatted Axial Computed Tomography Images in Isolation Will Miss Narrow S1 Transsacral Screw Corridors.

OBJECTIVE: To evaluate S1 transsacral (TS) corridors on reformatted and nonreformatted computed tomography (CT) images to determine which most reliably identifies narrow corridors. DESIGN: Retrospective cohort. SETTING: Level 1 trauma center. PATIENTS: Two hundred forty-five patients with operative pelvic ring injuries. INTERVENTION: CT scan review. MAIN OUTCOME MEASUREMENTS: Preoperative CT scans were evaluated to determine the width of the S1 TS corridor on standard axial nonreformatted (ANR), axial reformatted (AR), and coronal reformatted images. Sensitivity and specificity of each format to detect a narrow corridor (<10 mm on AR or coronal reformatted) were calculated. Patients with S1 TS screws were evaluated to determine the rate of screw breach with narrow corridors. RESULTS: The axial width of the S1 TS corridor was consistently smaller on ANR versus AR images (mean difference 1.4mm, 95% confidence interval 1.1-1.5). The corridor width on ANR images was on average 86% of the AR measurement. ANR images had the highest sensitivity and specificity (100% and 98%) for detecting S1 TS corridors <10 mm. Fifty-three S1 TS screws were placed in corridors ranging 10-23 mm on AR images and 7-19 mm on ANR images. Four (57%) of the 7 screws placed in corridors less than 10 mm in width on ANR images breached the sacral cortex. CONCLUSION: Using ANR images to measure the S1 TS corridor consistently measured smaller widths than AR images and identified all narrow corridors. A high rate of screw breach was noted with screw placement in narrow corridors. LEVEL OF EVIDENCE: Diagnostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Bilateral subtrochanteric stress riser fractures following percutaneous screw fixation of femoral neck stress fractures: a literature review and case report.

Hip and groin pain in patients at-risk for femoral neck stress fracture demand a careful workup including advanced imaging in the setting of normal radiographs. A delay in diagnosis can lead to fracture displacement, which negatively impacts outcomes. Non-displaced tension-sided fractures and displaced fractures warrant operative fixation, while non-displaced compression-side fractures can be managed conservatively. Fixation with a sliding hip screw or cephalomedullary nail is recommended over cannulated screws. In addition, all patients should undergo a metabolic workup to identify correctable parameters. We present a rare case of bilateral compression-sided basicervical femoral neck stress fractures in a non-compliant osteoporotic patient who was treated with cannulated screws. The postoperative course was complicated by bilateral subtrochanteric stress riser fractures requiring revision fixation, which could have been prevented with use of a different implant.

Practice patterns and adherence to nutrition guidelines in acute pancreatitis: An international physician survey.

BACKGROUND: There is agreement among GI society guidelines for recommending early oral nutrition with non-liquid diet in patients with mild acute pancreatitis (AP). There is less agreement regarding administration of tube feedings (TF) in AP. Data on physicians' adherence to nutrition guidelines and practice variations are limited. AIMS: To report practice patterns in the nutritional management of different severity profiles of AP. METHODS: We conducted an anonymous electronic survey among physician members of the International Association of Pancreatology and the American Pancreatic Association. We assessed nutrition practices based on severity of AP, and asked relevant questions regarding the preferred administration strategies for enteral nutrition. Responses were compared by practice location and subspecialty. RESULTS: A total of 178 physicians, mostly medical pancreatologists (40.4%) and surgeons (34.8%) from Europe (43.4%) and North America (32%) responded. Overall, only 26.7% initiated oral nutrition in mild AP on day 1, 40.9% waited >48 h, and 57.3% initiated nutrition with liquid diets. Physicians reported frequently using TF in patients with moderately-severe (30-75%, depending on the amount and location of necrosis) and severe AP (75-80%). Two-thirds of physicians preferred initiating TF after 48 h, administering it post-pylorically, and using semi-elemental or polymeric formulas. Median TF duration was 11 days (IQR, 7-21). Significant variations were noted based on geographic location and physician subspecialty for several aspects of nutritional practices in both mild and non-mild AP. CONCLUSION: Adherence to oral nutrition guideline recommendations for mild AP is low. There is significant variability in the use of TF in AP. Our study highlights opportunities for improving consistency of nutrition care in AP and identify potential areas for research.

Development and initial validation of an instrument for video-based assessment of technical skill in ERCP.

BACKGROUND AND AIMS: The accurate measurement of technical skill in ERCP is essential for endoscopic training, quality assurance, and coaching of this procedure. Hypothesizing that technical skill can be measured by analysis of ERCP videos, we aimed to develop and validate a video-based ERCP skill assessment tool. METHODS: Based on review of procedural videos, the task of ERCP was deconstructed into its basic components by an expert panel that developed an initial version of the Bethesda ERCP Skill Assessment Tool (BESAT). Subsequently, 2 modified Delphi panels and 3 validation exercises were conducted with the goal of iteratively refining the tool. Fully crossed generalizability studies investigated the contributions of assessors, ERCP performance, and technical elements to reliability. RESULTS: Twenty-nine technical elements were initially generated from task deconstruction. Ultimately, after iterative refinement, the tool comprised 6 technical elements and 11 subelements. The developmental process achieved consistent improvements in the performance characteristics of the tool with every iteration. For the most recent version of the tool, BESAT-v4, the generalizability coefficient (a reliability index) was .67. Most variance in BESAT scores (43.55%) was attributed to differences in endoscopists' skill, indicating that the tool can reliably differentiate between endoscopists based on video analysis. CONCLUSIONS: Video-based assessment of ERCP skill appears to be feasible with a novel instrument that demonstrates favorable validity evidence. Future steps include determining whether the tool can discriminate between endoscopists of varying experience levels and predict important outcomes in clinical practice.

Diagnostic performance of salivary pepsin for gastroesophageal reflux disease.

Uncertain diagnostic performance has limited clinical adoption of salivary pepsin, a noninvasive diagnostic tool for gastroesophageal reflux disease (GERD). This study aimed to assess diagnostic performance of salivary pepsin, and test validity of thresholds in an external cohort of patients with or without GERD. This two-phase prospective study conducted at two centers enrolled adult asymptomatic volunteers, patients with symptoms of GERD undergoing reflux monitoring, and patients with Barrett's esophagus (BE). Fasting saliva samples were processed for pepsin concentration using Peptest. Phase 1 compared pepsin concentration between No GERD (volunteers/functional heartburn) and GERD (erosive reflux disease/nonerosive reflux disease (NERD)/BE). Phase 2 tested validity of the diagnostic thresholds identified from Phase 1 among external functional heartburn and NERD cohorts. Of 243 enrolled subjects, 156 met inclusion criteria. Phase 1 (n = 114): Pepsin concentrations were significantly higher in GERD (n = 84) versus No GERD (n = 30) (73.8 ng/mL vs. 21.1 ng/mL; P < 0.001). Area under the curve for pepsin concentration was 0.74 (95% CI 0.65, 0.83). A salivary pepsin threshold of 24.9 ng/mL optimized the true negative rate and 100.0 ng/mL optimized the true positive rate. Phase 2 (n = 42): Pepsin concentrations were significantly higher in NERD (n = 22) versus Functional Heartburn (n = 20) (176.0 ng/mL vs. 53.3 ng/mL, P < 0.001). Applying Phase 1 thresholds in this external cohort, salivary pepsin 24.9 ng/mL was 86% sensitive (64%, 97%) and 100.0 ng/mL was 72% specific for distinguishing NERD from functional heartburn. Given modest sensitivity and specificity for GERD, salivary pepsin may have clinical utility as a noninvasive office based diagnostic screening tool for GERD.

Adding efficiency to proficiency: a study of trainee polypectomy efficiency metrics.

BACKGROUND: Although validated colonoscopy assessment tools exist, they do not measure efficiency. This study aimed to assess content validity of polypectomy efficiency (PE) and neoplastic polypectomy efficiency (NPE) as colonoscopy efficiency indices. METHODS: Data from a randomized controlled trial evaluating polypectomy among gastroenterology trainees were utilized. PE and NPE were defined as number of polyps (or neoplastic polyps) removed/withdrawal time × 100. Content validity was assessed by determining the association between efficiency indices and polypectomy times. RESULTS: 20 trainees performed 601 colonoscopies. There was a strong association between PE/NPE and actual polypectomy times: as polypectomy time increased by 1 minute, the PE decreased by 0.48 (P = 0.001) and NPE decreased by 0.24 (P = 0.03). CONCLUSIONS: The study proposed and provided content validity for PE and NPE as colonoscopy efficiency indices.

Recurrence Is Rare Following Complete Eradication of Intestinal Metaplasia in Patients With Barrett's Esophagus and Peaks at 18 Months.

BACKGROUND & AIMS: There have been few studies describing the long-term durability of complete eradication of intestinal metaplasia (CE-IM) in patients with Barrett's esophagus (BE)-related neoplasia who received endoscopic eradication therapy (EET). Data are needed to guide surveillance interval protocols and identify patients at risk for recurrence. We assessed the rate of recurrence of intestinal metaplasia and dysplasia, histologic features, and outcomes after recurrence of CE-IM, and identified factors associated with recurrence. METHODS: We performed a prospective study of 807 patients with BE who underwent EET, which produced CE-IM, at 4 tertiary-care referral centers, from January 2013 to October 2018. Kaplan-Meier estimates of cumulative incidence rates (IR) of recurrence were calculated for up to 5 years following CE-IM and were stratified by baseline level of histology. Density estimates of recurrence were used to determine the change in the rate of recurrence over time. We conducted logistic regression analysis to identify factors associated with recurrence. RESULTS: Intestinal metaplasia recurred in 121 patients (15%; IR, 5.2/100 person-years), and dysplasia recurred in 41 patients (5.1%; IR, 1.8/100 person-years), after a median follow-up time of 2317 person-years. The rate of recurrence was not constant and the time to any recurrence converged to a normal distribution; recurrences peaked at 1.6 y after patients had CE-IM. Baseline high-grade dysplasia or intramucosal cancer (adjusted odds ratio [aOR], 4.19), presence of reflux symptoms (aOR, 12.1) or hiatal hernia (aOR, 13.8), and number of sessions required to achieve CE-IM (aOR, 1.8) were associated with recurrence. CONCLUSIONS: In a prospective study of a large cohort of patients with BE undergoing EET, we found a low rate of recurrence after CE-IM. The rate of recurrence peaked at 1-2 y after CE-IM. These findings indicate that aggressive surveillance might not be necessary more than 1 y after CE-IM and should be considered in surveillance guidelines. Clinicaltrials.gov no: NCT02634645.

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.

Time Given to Trainees to Attempt Cannulation During Endoscopic Retrograde Cholangiopancreatography Varies by Training Program and Is Not Associated With Competence.

Advanced endoscopy training programs (AETPs) were developed as a result of the lack of comprehensive endoscopic retrograde cholangiopancreatography (ERCP) training during gastroenterology fellowships. There is no standardized curriculum for AETPs and the influence of program- and trainer-associated factors on trainee competence in ERCP has not been investigated adequately. In prior work, we showed that advanced endoscopy trainees (AETs) achieve ERCP competence at varying rates.1,2 The aims of this study were to measure the variability in time given to AETs to attempt cannulation between AETPs and throughout the 1-year training period, and to determine the association between AET cannulation time and AET competence at the end of training.

Effect of individualized feedback on learning curves in EGD and colonoscopy: a cluster randomized controlled trial.

BACKGROUND AND AIMS: Gastroenterology fellowships need to ensure that trainees achieve competence in upper endoscopy (EGD) and colonoscopy. Because the impact of structured feedback remains unknown in endoscopy training, this study compared the effect of structured feedback with standard feedback on trainee learning curves for EGD and colonoscopy. METHODS: In this multicenter, cluster, randomized controlled trial, trainees received either individualized quarterly learning curves or feedback standard to their fellowship. Assessment was performed in all trainees using the Assessment of Competency in Endoscopy tool on 5 consecutive procedures after every 25 EGDs and colonoscopies. Individual learning curves were created using cumulative sum (CUSUM) analysis. The primary outcome was the mean CUSUM score in overall technical and overall cognitive skills. RESULTS: In all, 13 programs including 132 trainees participated. The intervention arm (6 programs, 51 trainees) contributed 558 EGD and 600 colonoscopy assessments. The control arm (7 programs, 81 trainees) provided 305 EGD and 468 colonoscopy assessments. For EGD, the intervention arm (-.7 [standard deviation {SD}, 1.3]) had a superior mean CUSUM score in overall cognitive skills compared with the control arm (1.6 [SD, .8], P = .03) but not in overall technical skills (intervention, -.26 [SD, 1.4]; control, 1.76 [SD, .7]; P = .06). For colonoscopy, no differences were found between the 2 arms in overall cognitive skills (intervention, -.7 [SD, 1.3]; control, .7 [SD, 1.3]; P = .95) or overall technical skills (intervention, .1 [SD, 1.5]; control, -.1 [SD, 1.5]; P = .77). CONCLUSIONS: Quarterly feedback in the form of individualized learning curves did not affect learning curves for EGD and colonoscopy in a clinically meaningful manner. (Clinical trial registration number: NCT02891304.).

Endoscopic Ultrasound Placement of Preloaded Fiducial Markers Shortens Procedure Time Compared to Back-Loaded Markers.

BACKGROUND & AIMS: Fiducial markers are inert radiopaque gold or carbon markers implanted in or near pancreatic tumor to demarcate areas for image-guided radiation therapy. Endoscopic ultrasound (EUS) pre-loaded fiducial needles (PLNs) have been developed to circumvent technical issues associated with traditional back-loaded fiducials (BLNs). We performed a randomized controlled trial to compare procedure times in patients with pancreatic adenocarcinoma undergoing EUS-guided placement of BLNs vs PLNs. METHODS: In a prospective study, 44 patients with pancreatic adenocarcinoma referred for fiducial marker placement at 2 tertiary care centers were assigned to groups that received PLNs (n = 22) or BLNs (n = 22); each group had the same proportion of patients with tumors of different locations (head or neck vs body or tail).The procedure was standardized among all endoscopists and placement of a minimum of 3 markers inside the tumor was defined as technical success. The times for procedure and fiducial placement were recorded, total number of fiducial markers used documented, and grade of procedure difficulty ranked by passing the needle or deploying the fiducials. Other recorded variables included tumor characteristics, fluoroscopy use, and the number of fiducials clearly seen by EUS and fluoroscopy. The primary aim was to compare the duration of EUS-guided fiducial insertion of BLNs vs PLNs. RESULTS: The median placement time was significantly shorter in the PLN group (9 min) than the BLN group (16 min) (P < .001). However, the 44% reduction in time did not reach pre-specified levels (≥60%). Similar results were found after stratifying by tumor location. Deployment of BLNs was easier than deployment of PLNs (P = .03). There was no significant difference between groups in technical success, number of fiducials placed, EUS or fluoroscopic visualization, or adverse events. During simulation computed tomography and image-guided radiation therapy, there was no difference between groups in visualization of fiducials, migration rate, or accuracy of placement. CONCLUSIONS: In a randomized controlled trial of 44 patients with pancreatic adenocarcinoma, we found EUS-guided placement of PLNs to require less time and produce similar results compared with BLNs. Further refinements in PLN delivery system are needed to increase the ease of deployment. Clinicaltrials.gov no: NCT02332863.

Anatomic location of Barrett's esophagus recurrence after endoscopic eradication therapy: development of a simplified surveillance biopsy strategy.

BACKGROUND AND AIMS: Surveillance endoscopy is recommended after endoscopic eradication therapy (EET) for Barrett's esophagus (BE) because of the risk of recurrence. Currently recommended biopsy protocols are based on expert opinion and consist of sampling visible lesions followed by random 4-quadrant biopsy sampling throughout the length of the original BE segment. Despite this protocol, some recurrences are not visibly identified. We aimed to identify the anatomic location and histology of recurrences after successful EET with the goal of developing a more efficient and evidence-based surveillance biopsy protocol. METHODS: We performed an analysis of a large multicenter database of 443 patients who underwent EET and achieved complete eradication of intestinal metaplasia (CE-IM) from 2005 to 2015. The endoscopic location of recurrence relative to the squamocolumnar junction (SCJ), visible recurrence identified during surveillance endoscopy, and time to recurrence after CE-IM were assessed. RESULTS: Fifty patients with BE recurrence were studied in the final analysis. Seventeen patients (34%) had nonvisible recurrences. In this group, biopsy specimens demonstrating recurrence were taken from within 2 cm of the SCJ in 16 of these 17 patients (94%). Overall, 49 of 50 recurrences (98%) occurred either within 2 cm of the SCJ or at the site of a visible lesion. Late recurrences (>1 year) were more likely to be visible than early (<1 year) recurrences (P = .006). CONCLUSIONS: Recurrence after EET detected by random biopsy sampling is identified predominately in the distal esophagus and occurs earlier than visible recurrences. As such, we suggest a modified biopsy protocol with targeted sampling of visible lesions followed by random biopsy sampling within 2 cm of the SCJ to optimize detection of recurrence after EET. (Clinical trial registration number: NCT02634645.).

Development and validation of a video-based cold snare polypectomy assessment tool (with videos).

BACKGROUND AND AIMS: Polyps <1 cm are the most commonly found polyps during colonoscopy. Cold snare removal is preferred given the significantly higher rate of incomplete resection associated with piecemeal biopsy forceps resection. There are currently no standardized tools to assess competence in cold snare polypectomy. This study aimed to develop and validate a cold snare polypectomy assessment tool (CSPAT). METHODS: Experts in cold snare polypectomy used a Delphi method to develop the CSPAT. Metrics with a greater than 85% agreement as being "important" or "very important" were included in the CSPAT. The tool included evaluation of polyp inspection, positioning, appropriate ensnarement of tissue to ensure a rim of normal tissue, tissue retrieval, and postpolypectomy site inspection. Experts in cold snare polypectomy used the CSPAT to evaluate preselected videos that were previously evaluated using the Direct Observation of Polypectomy Skills (DOPyS) tool. Interobserver agreement was evaluated. CSPAT scores were compared with DOPyS scores to assess content validity. RESULTS: Sixteen experts developed the 12-item CSPAT, and 13 experts reviewed 55 videos. There was a moderate degree of agreement in 10 metrics (κ = .52-.59) and a substantial degree of agreement (κ = .61-.63) in the other 2. There was a strong correlation between the mean of individual metrics 1 to 12 compared with the global competence assessment (ρ = .88, P < .001). There was a moderate correlation between the average overall DOPyS score and the overall CSPAT competence score (ρ = .56, P < .001). CONCLUSIONS: We have developed and validated a customized CSPAT that can be easily applied to video-based assessments to assess competence in training and among practicing endoscopists.

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.).