Society: ASGE

INTRODUCTION:
Training in interventional endoscopy is offered by interventional endoscopy fellowship programs (IEFPs) not accredited by the ACGME. The number of these programs has increased exponentially with a concurrent increase in the breadth and complexity of these procedures. ACGME-accredited fellowships are governed by competency-based education, yet what constitutes a “high-quality” non-accredited IEFP has not been defined. Using an evidence-based consensus process, we aimed to establish minimum standards for IEFPs.

METHODS:
The RAND UCLA Appropriateness Method, a modified Delphi process to develop quality indicators (QIs), was utilized. A task force drafted potential QIs (structure, process and outcome) in 6 categories: a) activity preceding training, b) structure of IEFPs, c) training in ERCP, d) EUS, e) endoscopic mucosal resection (EMR) and f) luminal stenting. Three rounds of iterative feedback from 20 experts were conducted. Round 0 involved discussion of project details. In Round 1 experts independently ranked proposed QIs on a 9-point scale ranging from highly inappropriate (1) to highly appropriate (9). Next, proposed QIs were discussed and re-worded in a group meeting followed by Round 2 in which experts independently re-ranked proposed QIs and provided benchmarks (when applicable). The median score for each QI was calculated. Mean absolute deviation from the median was calculated and appropriateness of potential QIs was assessed using: (i) BIOMED Concerted Action on Appropriateness definition, (ii) P-value method and (iii) inter-percentile range adjusted for symmetry definition. A QI was deemed appropriate if median score was ≥7 and met criteria for appropriateness using all 3 defined statistical methods.

RESULTS:
Of 89 proposed QIs, 37 met criteria as appropriate for a QI (activity preceding training, 2; structure of IEFPs, 10; ERCP, 7; EUS, 8; EMR, 7; luminal stenting, 3) (Tables 1 & 2). Minimum thresholds were defined for 19 relevant QIs for number of trainers, procedures during fellowship and procedures prior to assessment of competence. Among the final appropriate QIs were that all trainees should undergo qualitative and quantitative competence assessments using validated tools at least quarterly with documented feedback throughout the training period and that trainees should track outcomes and relevant quality metrics for specific procedures.

CONCLUSION:
This ASGE-led initiative established minimum standards for training in interventional endoscopy. These may be assessed by all stakeholders and would ensure adequate training in interventional endoscopic procedures (ERCP, EUS, EMR, luminal stenting) during fellowship. This would also facilitate compliance with the ACGME/Next Accreditation System requirements of ensuring that trainees reach specific milestones in their progression to achieving cognitive and technical competency.

<b>Table 1: Appropriate measures for minimum standards for interventional endoscopy fellowship programs (IEFPs) – activity preceding training, structure of training programs and ERCP training (all measures rated as appropriate using BIOMED, p-value and IPRAS)</b>

Table 1: Appropriate measures for minimum standards for interventional endoscopy fellowship programs (IEFPs) – activity preceding training, structure of training programs and ERCP training (all measures rated as appropriate using BIOMED, p-value and IPRAS)

<b>Table 2: Appropriate measures for minimum standards for interventional endoscopy training programs – EUS, EMR and luminal stenting training (all measures rated as appropriate using BIOMED, p-value and IPRAS)</b>

Table 2: Appropriate measures for minimum standards for interventional endoscopy training programs – EUS, EMR and luminal stenting training (all measures rated as appropriate using BIOMED, p-value and IPRAS)

Background: Assessment of competence in endoscopic retrograde cholangiopancreatography (ERCP) is essential to ensure trainees possess the skills needed for independent practice. Traditionally, ERCP training has used the apprenticeship model, whereby novices learn skills under the supervision of an expert. A growing focus on procedural quality, however, has supported the implementation of competency-based medical education models which require documentation of a trainee’s competence for independent practice. Observational assessment tools with strong evidence of validity are critical to this process. Validity evidence supporting ERCP observational assessment tools has not been systematically evaluated.

Purpose: To conduct a systematic review of ERCP assessment tools and identify tools with strong evidence of validity using a unified validity evidence framework

Methods: We conducted a systematic search using electronic databases and hand-searching from inception until August 2021 for studies evaluating observational assessment tools of ERCP performance. We used a unified validity framework to characterize validity evidence from five sources: content, response process, internal structure, relations to other variables, and consequences. Each domain was assigned a score of 0-3 (maximum score 15). We assessed educational utility and methodological quality using the Accreditation Council for Graduate Medical Education framework and the Medical Education Research Quality Instrument, respectively.

Results: From 2769 records, we included 17 studies evaluating 7 assessment tools. Five tools were studied for clinical ERCP, one on simulated ERCP, and one on simulated and clinical ERCP. Validity evidence scores ranged from 2-12. The Bethesda ERCP Skills Assessment Tool (BESAT), ERCP Direct Observation of Procedural Skills Tool (ERCP DOPS), and The Endoscopic Ultrasound (EUS) and ERCP Skills Assessment Tool (TEESAT) had the strongest validity evidence with scores of 10, 12, and 11, respectively. Regarding educational utility, most tools were easy to use and interpret, and required minimal additional resources. Overall methodological quality was strong, with scores ranging from 10-12.5 (maximum 13.5).

Conclusions: The BESAT, ERCP DOPS, and TEESAT have strong validity evidence compared to other assessments. Integrating tools into training may help drive learners’ development and support competency decision-making.

Background: The recently developed CAD EYE system (Fujifilm, Tokyo, Japan), which provides artificial intelligence (AI) -aided endoscopic diagnosis, has the potential to improve the detection for colorectal polyps. It is essential that gastroenterology trainees improve the quality of total colonoscopy (CS) operations and accelerate their technical progress. The aim of this study was to determine the utility of CAD EYE for CS by comparing endoscopic observation using CAD EYE with conventional endoscopic observation (i.e., white light imaging) in outpatients undergoing CS performed by gastroenterology trainees (i.e., beginner endoscopists).
Methods: This was a multi-center, randomized controlled trial at Ureshino Medical Center, Karatsu Red Cross Hospital and Saga University Hospital (UMIN000044031). The study received an academic research grant from the Japanese Society of Gastrointestinal Endoscopy in 2021. Patients were divided into group A (observed using CAD EYE) and group B (observed using white light imaging). Six gastroenterologists with limited experience in CS (i.e., trainees in their third or fourth year after graduation) performed CS using a back-to-back method in pairs with a gastroenterology specialist. The primary endpoint was the adenoma detection rate. The secondary endpoints were the adenoma miss rate (AMR) and 14 assessment of competency in endoscopy tool scores. The learning curve of each trainee was evaluated using the cumulative sum control chart.
Results: We analyzed 231 cases (113 in group A, 118 in group B) enrolled from May 2021 to March 2022. There was no difference in the adenoma detection rate of trainees between group A and group B (58.4% versus 61.0%, respectively; p=0.690). There was a significantly lower AMR (26.6% versus 39.7%, respectively; p=0.036) and number of missed adenomas per patient (0.5 versus 0.9, respectively; p=0.004) in group A compared with group B. Group A also scored significantly higher than group B on two items of the assessment of competency in endoscopy tool score—i.e., pathology identification (2.26 versus 2.07, respectively; p=0.030) and interpretation and identifying location of pathology (2.18 versus 2.00, respectively; p=0.038). For the cumulative sum learning curve of trainees, the number of cases in which multiple adenomas were missed by the six trainees who performed CS was lower in group A. Even after accumulating cases, the number of missed adenomas remained consistently lower in group A.
Conclusions: The use of CAD EYE can decrease the AMR and improve the ability to accurately locate and identify colorectal adenomas. Thus, CAD EYE is particularly useful for CS in beginning endoscopists.

Background: There is a lack of data on training benchmarks to define competence in colorectal EMR (C-EMR) among advanced endoscopy trainees (AETs). Previous pilot data from our group demonstrated a relatively low proportion of AETs achieve competence on key cognitive and technical aspects of C-EMR. We aimed to perform an interim analysis on C-EMR training among AETs and assess their performance using the EMR-STAT during the first trimester of their advanced endoscopy fellowship (AEF).
Methods: Prospective multicenter study evaluating AETs C-EMR training using the EMR-STAT. The tool was previously validated in the pilot study for standardized evaluation of key cognitive and technical C-EMR skills (Figure 1). A 4-point scoring system was used to grade these endpoints. Global rating was provided using a 10-point scoring system. For interim analysis, competence was defined as a score of 3 or 4 for each endpoint and ≥7 for overall assessment. Cumulative sum analysis was used to establish competence for cognitive and technical components of C-EMR and overall performance. Prior to the study, participating AETs completed questionnaire about their GI fellowship training in endoscopic resection.
Results: Twenty-five AETs from 18 institutions are enrolled in this ongoing study. On survey questionnaire, the AETs reported having performed a mean of 41.4 C-EMRs (interquartile range [IQR]: 10-50) before the onset of their AEF and most received cognitive training in C-EMR during their general GI fellowship (n=20; 80%). In the first trimester of their AEF, out of the 25 AETs, 15 have performed a mean of 9.1 C-EMRs (range 1-30). Mean lesion size was 26.7±11.6 and mean EMR time of 26.1±18.1 minutes. En-bloc resection rate for polyp sizes 11-20 mm was 41.3% (19/46). Competence in cognitive skills, such as assessment of polyp morphology and pit/vascular pattern, was achieved by AETs in 90.4% and 83.1%, respectively. AETs were graded as competent in submucosal lift injection and snare resection in 69.9% and 63.2%, respectively. Overall competence based on the global score was attained in 53.7% of the cases. On cumulative sum analysis, only 2 AETs crossed the competence threshold for cognitive skills and 1 AET for technical skills. The minimum threshold to achieve competence was 18 C-EMRs (Figure 2).
Conclusions: Standardized evaluation of competence in C-EMR training is critical for quality assurance in patient care. There was high variability in the number of C-EMRs performed by AETs and low overall en-bloc resection rates for polyps 11-20 mm in size. In aggregate, AETs were graded as competent in only half of the C-EMR cases and only 2 AETs have crossed the minimum threshold of competence. Ongoing data acquisition from this study will provide insight into the current state of C-EMR training during AEF and establish competence thresholds for quality metrics.

Figure 1. EMR Standardized Assessment Tool (EMR-STAT)

Figure 1. EMR Standardized Assessment Tool (EMR-STAT)

Figure 2. Representation of the learning curves among AETs by using cumulative sum (CUSUM) analysis for core cognitive and technical skills during C-EMR training.

Figure 2. Representation of the learning curves among AETs by using cumulative sum (CUSUM) analysis for core cognitive and technical skills during C-EMR training.

Background/aims: In endoscopic retrograde cholangiopancreatography (ERCP) training, deep biliary cannulation (BC) in patients with native papilla (NP) is used as a surrogate for trainee’s competency. However, the success rate of BC with standard technique (ST) may be suboptimal during their early training period. The next step to achieve BC would be either precut-sphincterotomy (PS) or double guidewire (DGW) cannulation. Due to the potential risk of complications, PS is usually performed by attending endoscopist. However, DGW technique (DWT) may be allowed trainees to perform as it appears less harmful. We aimed to assess the BC success rate (BSR) and safety of DWT performed by trainees.
Method: We prospectively enrolled patients with NP who underwent ERCP with trainee involvement at our institute between 2019-2022. Nine trainees without prior ERCP experience participated in the study. Unsuccessful standard BC by the trainee was defined if BC could not be achieved by ST within 10 minutes and/or probing ampulla >5 attempts. When inadvertent GW insertions in the pancreatic duct (PD) occurred >3 times with ST, the trainees, who had successful BC with ST for at least 10 cases, were allowed to perform DWT as the next step. Failed DWT was defined if BC could not be achieved within 10 minutes. Following failed BC using ST and/or DWT by the trainees, the staffs subsequently performed BC with ST or DWT at their discretion. If ST or DWT was still unsuccessful, the staffs eventually performed PS as a rescue technique.
Results: 453 patients with NP underwent ERCP with trainees as the starter. Trainees achieved deep BC by ST in 224(49%) patients (Figure). The other 229 patients who failed ST by trainees, 86 patients had inadvertent PD cannulation by trainees then they had subsequent DWT and 52/86 (60%) succeeded BC. Among 177 patients with unsuccessful ST by trainees, 104 (98%) and 63 (89%) patients achieved BC using ST and DWT performed by staffs, respectively. Of 10 patients who failed BC with ST and/or DWT by staffs, 9 patients had PS as a rescue technique. One patient had repeat ERCP which was successful in the next 2 days. Overall BSR among trainees increased from 224/453(49%) by using ST to 276/453(61%) after additional DWT. Subgroup analysis in patients who had unsuccessful ST by trainees and received additional DWT by trainees(n=86) and by staffs(n=71) was performed. Although BSR using additional DWT in staffs was significantly higher than those in trainees [63/71(88.7%) vs. 52/86(60.5%); p<0.001], the rates of post-ERCP pancreatitis were not different between both groups [9.3% vs. 14.1%; p=0.35].
Conclusion: After failed BC with ST during early ERCP training, trainees should be allowed to perform DWT as the technique can increase BSR, although BSR could be lower than DWT performed by attending staffs, the rate of post-ERCP pancreatitis was comparable.

<b>Figure.</b> The flowchart of The success rate and safety of double guidewire cannulation performed by trainees after failed standard cannulation

Figure. The flowchart of The success rate and safety of double guidewire cannulation performed by trainees after failed standard cannulation

<b>Table.</b> Baseline characteristic and outcomes of additional double guidewire technique (DWT) performed by trainees (n=86) and staffs (n=71) in patients who failed standard biliary cannulation by trainees

Table. Baseline characteristic and outcomes of additional double guidewire technique (DWT) performed by trainees (n=86) and staffs (n=71) in patients who failed standard biliary cannulation by trainees

Background and aims: Trainees usually require a long learning curve in >200 cases with native ampulla (NP) to achieve biliary cannulation (BC) >80% by standard technique (ST). Because, precut the next step to achieve biliary access, trainees are not allowed due to it inherited risk of complications thus cannulation-practice time was only with ST in the conventional training model. Double guidewire technique (DWT) is other alternative that carry lower risk and trainees may be allowed to perform as the next step. We aimed to evaluate the learning curve to achieve 80% BC with ST and DWT during ERCP training in the early period of advanced endoscopy trainees.
Method: Between 2019-2022, 9 advanced endoscopy trainees without prior ERCP experience participated in the study. In patients with NP, initial BC with ST was attempted by the trainees. When inadvertent GW insertions in the pancreatic duct >3 times with ST, the trainees, who had previously performed BC with ST for at least 10 cases, performed DWT as the next step. Failed standard cannulation was defined if BC was unsuccessful by ST within 10 minutes and/or probing ampulla >5 attempts. Failed DWT was defined when deep BC was unsuccessful within 10 minutes. If ST or DWT was unsuccessfully done by the trainees, the attending staff would subsequently take over. Biliary cannulation success rate (BSR) in the first phase of ERCP training (initial 1-25 cases for each trainee) and in the second phase (after 25 cases) were compared. Model for the adjusted probabilities of successful BC was presented as a learning curve of ST and DWT among advanced endoscopy trainees.
Results: A total of 453 patients underwent ERCP with trainee as the starter. Overall BSR using either ST or DGW by trainees was 60.9% (276/453). When compared between the first and second phases, baseline characteristics of patients were not different (Table). In the first phase of training among 9 trainees, BSR ranged from 33% to 60%. Each trainee’s BSR improved in the second phase, varying from 50% to 84%. BSR significantly increased from 51.8 (113/218) in the first phase to 69.3% (163/235) in the second phase (p<0.01). There were no differences in median total cannulation time (10.1 min vs. 8.6 min; p=0.81) and procedure-related adverse events [19(8.7%) vs. 23(9.9%); p=0.66] between the first and second phases. Using a model for the adjusted probabilities of successful BC using ST and/or DWT; trainee’s BSR reached 50% after first 25 cases. BSR reached 80% when the trainees continued to perform at least 45 cases more in second phase (Figure).
Conclusion: In the second phase (after 25 cases) during training in BC, the overall success rate among trainees increased from 52% to 69%. To achieve 80% deep BC without increasing the risk of complications, trainees should be allowed to perform both ST and DWT since the beginning for at least 70 cases.

<b>Table.</b> Baseline characteristic of patients who underwent ERCP with nine trainees involvement (n=453)

Table. Baseline characteristic of patients who underwent ERCP with nine trainees involvement (n=453)

<b>Figure.</b> The adjusted probabilities of successful biliary cannulation as a learning curve of standard technique and double guidewire technique among nine advanced endoscopy trainees

Figure. The adjusted probabilities of successful biliary cannulation as a learning curve of standard technique and double guidewire technique among nine advanced endoscopy trainees

Background: Per-oral endoscopic myotomy (POEM) is a technically challenging yet effective treatment for achalasia. Endoscopic submucosal entry and tunneling enable disruption of the lower esophageal sphincter (LES). The single-operator learning curve for POEM is around 25 cases as measured by reduction in complications and improvement in Eckhardt score. There is evidence in the Japanese population that prior training in endoscopic submucosal dissection (ESD) may shorten the learning curve for POEM. We aim to assess the impact of prior training in ESD on the learning curve for POEM at a tertiary care referral center in Los Angeles, CA.

Methods: This observational case series includes patients who underwent POEM for achalasia from 2018 to 2022. The primary end point was the improvement in Eckhardt score. Secondary end points were the post-procedure frequency of reflux symptoms, Los Angeles Classification for esophagitis, acid exposure time and DeMeester score. Each patient underwent a comprehensive pre and post procedure office visit, Bravo pH study and endoscopic evaluation. The primary operator had trained in ESD in Japan and had a case experience of >30 ESD procedures prior to beginning the POEM program. Data was grouped into experience quartiles for Pearson Chi-square analysis, which was accomplished using SAS Statistical Software.

Results: Among 30 patients who underwent POEM, 57% were female, 47% Hispanic and their mean age was 55 (+/-SD) years). By pre-procedure manometric evaluation, 10.3% of cases were Type 1 achalasia, 72.4% of cases were Type 2 achalasia, and 17.2% of cases were Type 3 achalasia. At three months post-POEM, patients underwent EGD with pH study off PPI for 1 week. Overall, 30.4% of patients had moderate-to-severe esophagitis (LA-B or higher), compared to 69.6% of cases with mild or no esophagitis. Median DeMeester score was 22.2, and median acid exposure time percentage was 4.1% (Table 1). 6.7% of cases had severe reflux symptoms. Two cases had complications – delayed esophageal perforation and pneumothorax, both managed conservatively.
When cases were grouped into experience quartiles, severe reflux was significantly less frequent in quartiles 2-4 (76.7% of all cases) compared to quartile 1 (23.3% of all cases). Eckhardt scores improved by 77.78 % (69.23 - 90.48) in quartile 1, compared to a 100% (77.78-100, P = 0.113) improvement in Eckhardt score in quartiles 2-4 (Table 2). Overall, 90% of patients had a post-POEM Eckhardt score of 3 or less, which represents a median improvement of 88.1% in Eckhardt score. This improvement was consistent across the training quartiles.

Conclusion: Prior training in ESD may shorten the learning curve for POEM from 25 cases to <10 cases, evidenced by improvement in outcomes after the first quartile of procedures. Further prospective studies are needed to validate this observation.

Characteristics of cases of achalasia that underwent per-oral endoscopic myotomy by single operator with prior experience in endoscopic submucosal dissection.

Characteristics of cases of achalasia that underwent per-oral endoscopic myotomy by single operator with prior experience in endoscopic submucosal dissection.

Outcomes of per-oral endoscopic myotomy for achalasia by single operator, grouped by experience quartiles (Q1 vs. Q2-Q4).

Outcomes of per-oral endoscopic myotomy for achalasia by single operator, grouped by experience quartiles (Q1 vs. Q2-Q4).

BACKGROUND: Endoscopic submucosal dissection (ESD) is increasingly adopted as a first-line resection strategy for superficial gastrointestinal neoplasia. Multiple pathways currently exist for ESD training in the US. Following our previous report of our experience with a formal one-year prevalence-based ESD training program incorporated within an accredited ASGE fourth-year advanced endoscopy fellowship, here we report efficiency, safety, and outcomes of subsequent independent ESD practice after four years at a US-based academic practice.
METHODS: Following completion of a formal ESD training program in 2017-2018, we prospectively analyzed consecutive ESDs performed by a single operator over a 4-year period from 2018-2022. Demographics, lesion and technical characteristics, resection outcomes and procedure time, adverse events, and final diagnoses were recorded. Learning curves for ESD with respect to en bloc resection, complete resection, and curative resection were derived, and separated into 25-case blocks. A 25-case moving average was derived to evaluate resection speed.
RESULTS:
ESD Type: 266 ESD cases were performed during the 4-year period, which included 4 esophageal, 30 gastric, 1 duodenal, and 231 (86.8%) colorectal cases (118 right colon, 38 left colon, 75 rectal). Mean lesion size and surface area were 5.1 cm (SD, 2.3 cm) and 20.5 cm²(SD, 23.0 cm²).
ESD Efficiency: En bloc resection, complete resection, and curative resection were achieved in 89.9%, 85.0%, and 76.7% respectively. Mean resection time was 103.9 min (SD, 74.9 min), with mean resection speed 16.2 cm²/hr (SD, 21.2 cm²/hr). A countertraction strategy was used in 8.3% of cases, and conversion to a hybrid ESD was necessary in 15.0% of cases. Resection defects were closed in 23.3% of cases. When separated into 25-case blocks, plateaus were seen in en bloc, complete, and curative resection rates. A 25-case moving average of resection speed started at 8.7 cm²/hr, reached the benchmark speed of 9.0 cm²/hr after 62 cases, and has continued to steadily increase over time.
ESD Outcome: Adverse events included major intraprocedural bleeding (0.8%), delayed bleeding (3.0%), intraprocedural perforation (0.4%), and delayed perforation (0.8%). One patient required emergency surgery for delayed perforation. There were 2 recurrences on mean 14.4 month follow-up (SD, 11.3 months), of which 1 was due to piecemeal resection and 1 was due to underlying pathology of a gastric hyperplastic polyp.
CONCLUSIONS: Formal fellowship training in ESD facilitated rapid subsequent achievement of proficiency in a primarily colorectal ESD practice setting. The results of this ongoing learning curve study continue to affirm the potential role of formal structured training in the US in allowing trainees to safely and effectively start independent practice at a higher point along the ESD learning curve.

George Chang

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