A novel blood-sensing capsule for rapid detection of upper GI bleeding: a prospective clinical trial.

BACKGROUND AND AIMS: Upper GI bleeding (UGIB) is a common medical emergency associated with high resource utilization, morbidity, and mortality. Timely EGD can be challenging from personnel, resource, and access perspectives. PillSense (EnteraSense Ltd, Galway, Ireland) is a novel swallowed bleeding sensor for the detection of UGIB, anticipated to aid in patient triage and guide clinical decision-making for individuals with suspected UGIB. METHODS: This prospective, open-label, single-arm comparative clinical trial of a novel bleeding sensor for patients with suspected UGIB was performed at a tertiary care center. The PillSense system consists of an optical sensor and an external receiver that processes and displays data from the capsule as "Blood Detected" or "No Blood Detected." Patients underwent EGD within 4 hours of capsule administration; participants were followed up for 21 days to confirm capsule passage. RESULTS: A total of 126 patients were accrued to the study (59.5% male; mean age, 62.4 ± 14.3 years). Sensitivity and specificity for detecting the presence of blood were 92.9% (P = .02) and 90.6% (P < .001), respectively. The capsule's positive and negative predictive values were 74.3% and 97.8%, and positive and negative likelihood ratios were 9.9 and .08. No adverse events or deaths occurred related to the PillSense system, and all capsules were excreted from patients on follow-up. CONCLUSIONS: The PillSense system is safe and effective for detecting the presence of blood in patients evaluated for UGIB before upper GI endoscopy. It is a rapidly deployed tool, with easy-to-interpret results that will affect the diagnosis and triage of patients with suspected UGIB. (Clinical trial registration number: NCT05385224.).

Defining the learning curves of colorectal surgical trainees in colonoscopy using the Assessment of Competency in Endoscopy tool.

BACKGROUND AND AIMS: Gastroenterology fellows require on average 250 to 275 colonoscopies to achieve competency. For surgical trainees, 50 colonoscopies is deemed adequate. Two training pathways using different assessment methods make any direct comparison impossible. At the Mayo Clinic colonoscopy training of gastroenterology and colorectal surgery (CRS) fellows were merged in 2017, providing a unique opportunity to define the learning curves of CRS trainees using the Assessment of Competency in Endoscopy (ACE) evaluation tool. METHODS: In a single-center retrospective descriptive study, ACE scores were collected on colonoscopies performed by CRS fellows over a period of 4 academic years. By calculating the average scores at every 25 procedures of experience, the CRS colonoscopy learning curves were described for each core cognitive and motor skill. RESULTS: Twelve CRS fellows (men, 8; women, 4) had an average prior experience of 123 colonoscopies (range, 50-266) during the general surgical residency. During CRS fellowship, an average of 136 colonoscopies (range, 116-173) were graded per fellow. Although the competency goals for a few metrics were met earlier, most motor and cognitive ACE metrics reached the minimum competency thresholds at 275 to 300 procedures. CONCLUSIONS: CRS fellows reached competency in colonoscopy at around 275 to 300 procedures of experience, a trajectory similar to previously reported data for gastroenterology fellows, suggesting little difference in the learning curves between these 2 groups. In addition, no trainee was deemed competent at the onset of training despite an average experience well over the 50 colonoscopies required during residency.

Randomized Phase II Trial of Polyphenon E versus Placebo in Patients at High Risk of Recurrent Colonic Neoplasia.

Polyphenon E (Poly E) is a green tea polyphenol preparation whose most active component is epigallocatechin gallate (EGCG). We studied the cancer preventive efficacy and safety of Poly E in subjects with rectal aberrant crypt foci (ACF), which represent putative precursors of colorectal cancers. Eligible subjects had prior colorectal advanced adenomas or cancers, and had ≥5 rectal ACF at a preregistration chromoendoscopy. Subjects (N = 39) were randomized to 6 months of oral Poly E (780 mg EGCG) daily or placebo. Baseline characteristics were similar by treatment arm (all P >0.41); 32 of 39 (82%) subjects completed 6 months of treatment. The primary endpoint was percent reduction in rectal ACF at chromoendoscopy comparing before and after treatment. Among 32 subjects (15 Poly E, 17 placebo), percent change in rectal ACF number (baseline vs. 6 months) did not differ significantly between study arms (3.7% difference of means; P = 0.28); total ACF burden was also similar (-2.3% difference of means; P = 0.83). Adenoma recurrence rates at 6 months were similar by arm (P > 0.35). Total drug received did not differ significantly by study arm; 31 (79%) subjects received ≥70% of prescribed Poly E. Poly E was well tolerated and adverse events (AE) did not differ significantly by arm. One subject on placebo had two grade 3 AEs; one subject had grade 2 hepatic transaminase elevations attributed to treatment. In conclusion, Poly E for 6 months did not significantly reduce rectal ACF number relative to placebo. Poly E was well tolerated and without significant toxicity at the dose studied. PREVENTION RELEVANCE: We report a chemoprevention trial of polyphenon E in subjects at high risk of colorectal cancer. The results show that polyphenon E was well tolerated, but did not significantly reduce the number of rectal aberrant crypt foci, a surrogate endpoint biomarker of colorectal cancer.

An Inexpensive, Portable Physical Endoscopic Simulator: Description and Initial Evaluation.

BACKGROUND: Surgeons and gastroenterologists in training benefit from simulation-based endoscopy education, yet the price of most training endoscopy simulators is prohibitive. We set out to create and evaluate a low-cost endoscopic simulator and box model trainer for learning fundamental endoscopic skills. METHODS: After adding a wireless network-enabled camera (total cost, $20) to a discarded clinical endoscope, we paired this with an easily constructed box trainer (cost $32) to generate an endoscopic simulator system (YazanoScope) for simulation training. Participants (general surgery interns, research fellows, and medical and college students) used the YazanoScope to train to mastery on 5 FES tasks. Outcomes included skill assessments on a computer simulator and trainees' perceptions comparing the physical model to the computer simulator. RESULTS: Forty trainees participated. The median (range) training time was 110 (60-180) min. Only 10% of trainees were able to reach the cecum at baseline compared to 100% after training. The mean (SD) time was 253 (154) s at baseline (including completers and non-completers) and 249 (89) after training (P = 0.88). On a retention test 2 wk later, 21 of 22 (96%) completed the computer simulator assessment (endoscope tip reached the cecum). Mean time was 214 (67) s (P = 0.32 compared with immediate posttraining). All 40 trainees believed the YazanoScope provided better haptic feedback than the computer simulator. CONCLUSIONS: Training with this inexpensive, portable endoscopic simulator (YazanoScope) was associated with increased procedure completion with no change in procedure time. All participants favored the haptic feedback of the $52 YazanoScope over a computer simulator.

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

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

ASGE EndoVators Summit: simulators and the future of endoscopic training.

Interest in the use of simulation for acquiring, maintaining, and assessing skills in GI endoscopy has grown over the past decade, as evidenced by recent American Society for Gastrointestinal Endoscopy (ASGE) guidelines encouraging the use of endoscopy simulation training and its incorporation into training standards by a key accreditation organization. An EndoVators Summit, partially supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health, (NIH) was held at the ASGE Institute for Training and Technology from November 19 to 20, 2017. The summit brought together over 70 thought leaders in simulation research and simulator development and key decision makers from industry. Proceedings opened with a historical review of the role of simulation in medicine and an outline of priority areas related to the emerging role of simulation training within medicine broadly. Subsequent sessions addressed the summit's purposes: to review the current state of endoscopy simulation and the role it could play in endoscopic training, to define the role and value of simulators in the future of endoscopic training and to reach consensus regarding priority areas for simulation-related education and research and simulator development. This white paper provides an overview of the central points raised by presenters, synthesizes the discussions on the key issues under consideration, and outlines actionable items and/or areas of consensus reached by summit participants and society leadership pertinent to each session. The goal was to provide a working roadmap for the developers of simulators, the investigators who strive to define the optimal use of endoscopy-related simulation and assess its impact on educational outcomes and health care quality, and the educators who seek to enhance integration of simulation into training and practice.

Supporting self-regulation in simulation-based education: a randomized experiment of practice schedules and goals.

Self-regulated learning is optimized when instructional supports are provided. We evaluated three supports for self-regulated simulation-based training: practice schedules, normative comparisons, and learning goals. Participants practiced 5 endoscopy tasks on a physical simulator, then completed 4 repetitions on a virtual reality simulator. Study A compared two practice schedules: sequential (master each task in assigned order) versus unstructured (trainee-defined). Study B compared normative comparisons framed as success (10% of trainees were successful) versus failure (90% of trainees were unsuccessful). Study C compared a time-only goal (go 1 min faster) versus time + quality goal (go 1 min faster with better visualization and scope manipulation). Participants (18 surgery interns, 17 research fellows, 5 medical/college students) were randomly assigned to groups. In Study A, the sequential group had higher task completion (10/19 vs. 1/21; P < .001), longer persistence attempting an ultimately incomplete task (20.0 vs. 15.9 min; P = .03), and higher efficiency (43% vs. 27%; P = .02), but task time was similar between groups (20.0 vs. 22.6 min; P = .23). In Study B, the success orientation group had higher task completion (10/16 vs. 1/24; P < .001) and longer persistence (21.2 vs. 14.6 min; P = .001), but efficiency was similar (33% vs. 35%; P = .84). In Study C, the time-only group had greater efficiency than time + quality (56% vs. 41%; P = .03), but task time did not differ significantly (172 vs. 208 s; P = .07). In this complex motor task, a sequential (vs. unstructured) schedule, success (vs. failure) orientation, and time-only (vs. time + quality) goal improved some (but not all) performance outcomes.

Assessment of competency in endoscopy: establishing and validating generalizable competency benchmarks for colonoscopy.

BACKGROUND AND AIMS: The Mayo Colonoscopy Skills Assessment Tool (MCSAT) has previously been used to describe learning curves and competency benchmarks for colonoscopy; however, these data were limited to a single training center. The newer Assessment of Competency in Endoscopy (ACE) tool is a refinement of the MCSAT tool put forth by the Training Committee of the American Society for Gastrointestinal Endoscopy, intended to include additional important quality metrics. The goal of this study is to validate the changes made by updating this tool and establish more generalizable and reliable learning curves and competency benchmarks for colonoscopy by examining a larger national cohort of trainees. METHODS: In a prospective, multicenter trial, gastroenterology fellows at all stages of training had their core cognitive and motor skills in colonoscopy assessed by staff. Evaluations occurred at set intervals of every 50 procedures throughout the 2013 to 2014 academic year. Skills were graded by using the ACE tool, which uses a 4-point grading scale defining the continuum from novice to competent. Average learning curves for each skill were established at each interval in training and competency benchmarks for each skill were established using the contrasting groups method. RESULTS: Ninety-three gastroenterology fellows at 10 U.S. academic institutions had 1061 colonoscopies assessed by using the ACE tool. Average scores of 3.5 were found to be inclusive of all minimal competency thresholds identified for each core skill. Cecal intubation times of less than 15 minutes and independent cecal intubation rates of 90% were also identified as additional competency thresholds during analysis. The average fellow achieved all cognitive and motor skill endpoints by 250 procedures, with >90% surpassing these thresholds by 300 procedures. CONCLUSIONS: Nationally generalizable learning curves for colonoscopy skills in gastroenterology fellows are described. Average ACE scores of 3.5, cecal intubation rates of 90%, and intubation times less than 15 minutes are recommended as minimal competency criteria. On average, it takes 250 procedures to achieve competence in colonoscopy. The thresholds found in this multicenter cohort by using the ACE tool are nearly identical to the previously established MCSAT benchmarks and are consistent with recent gastroenterology training recommendations but far higher than current training requirements in other specialties.

Looping and Abdominal Pressure: A Visual Guide to a Successful Colonoscopy.

Looping is a common occurrence during colonoscopy. Once a loop has occurred and the endoscopist has reduced it, abdominal pressure given by the technician will help the loop from re-forming. In this article, we discuss some of the common loops that are formed, the methods the endoscopist must employ to reduce the loop, and the type of abdominal pressure used by the technician to help prevent the loop from re-forming and, thus, help attain cecal intubation. Hand placement for abdominal pressure is discussed and illustrated to provide a visual guide for the technician.

Effects of simulation-based training in gastrointestinal endoscopy: a systematic review and meta-analysis.

BACKGROUND & AIMS: Simulation-based training (SBT) in gastrointestinal endoscopy has been increasingly adopted by gastroenterology fellowship programs. However, the effectiveness of SBT in enhancing trainee skills remains unclear. We performed a systematic review with a meta-analysis of published literature on SBT in gastrointestinal endoscopy. METHODS: We performed a systematic search of multiple electronic databases for all original studies that evaluated SBT in gastrointestinal endoscopy in comparison with no intervention or alternative instructional approaches. Outcomes included skills (in a test setting), behaviors (in clinical practice), and effects on patients. We pooled effect size (ES) using random-effects meta-analysis. RESULTS: From 10,903 articles, we identified 39 articles, including 21 randomized trials of SBT, enrolling 1181 participants. Compared with no intervention (n = 32 studies), SBT significantly improved endoscopic process skills in a test setting (ES, 0.79; n = 22), process behaviors in clinical practice (ES, 0.49; n = 8), time to procedure completion in both a test setting (ES, 0.79; n = 16) and clinical practice (ES, 0.75; n = 5), and patient outcomes (procedural completion and risk of major complications; ES, 0.45; n = 10). Only 5 studies evaluated the comparative effectiveness of different SBT approaches; which provided inconclusive evidence regarding feedback and simulation modalities. CONCLUSIONS: Simulation-based education in gastrointestinal endoscopy is associated with improved performance in a test setting and in clinical practice, and improved patient outcomes compared with no intervention. Comparative effectiveness studies of different simulation modalities are limited.

Small-bowel endoscopy core curriculum.

This is one of a series of documents prepared by the ASGE Training Committee. This curriculum document contains recommendations for training, intended for use by endoscopy training directors, endoscopists involved in teaching endoscopy, and trainees in endoscopy. It was developed as an overview of techniques currently favored for the performance and training of small-bowel endoscopy and to serve as a guide to published references, videotapes, and other resources available to the trainer. By providing information to endoscopy trainers about the common practices used by experts in performing the technical aspects of the procedure, the ASGE hopes to improve the teaching and performance of small-bowel endoscopy.