Faculty Bibliography

Introduction: Duodenoscopes are used in more than 500,000 procedures annually in the US as a minimally invasive diagnostic and therapeutic modality for hepatobiliary and pancreatic diseases. Traditionally, these devices have been intended for re-use after undergoing strict cleaning and disinfection protocols to reduce the risk of infection between patients. However, since 2008, several major outbreaks of infections linked to duodenoscopes have resulted in devices recalled from the market. Understanding what occurred in instances of device failure leading to recalls is important to improve the safety and efficacy of these devices.
Method(s): This institution review board-exempt study reviewed the FDA Center for Devices and Radiologic Health database for all duodenoscope-related recall events from November 1, 2002 through December 31, 2020. Market entry data, recall characteristics, and adverse reports were collected for each device.
Result(s): Seventeen class II duodenoscope-related recall events were identified, affecting at least 24,611 units in distribution. 12 out of the 17 (70%) recall events were for duodenoscopes, 3 out of 17 (18%) recalls were for operation manuals, and 2 out of 17 (12%) recalls were for reprocessors. 15 out of 17 recalled devices (88%) had at least 1 documented occurrence of an adverse event at the time of recall. All recall events were approved via the 510k pathway, however postmarket-related issues accounted for 88% of recalls.
Conclusion(s): Given the wide utilization of duodenoscopes in treating pancreaticobiliary diseases, an understanding of their recall events and associated public health impact are important for endoscopists to have a greater awareness of potential safety concerns. Recalls by three duodenoscope manufacturers and one scope reprocessor manufacturer highlight the need for innovation in design and improved post-marketing surveillance mechanisms

Introduction: Multiple recent outbreaks of multidrug resistant organisms (MDRO) related to contaminated duodenoscopes have led to increased scrutiny of duodenoscope standard reprocessing methods. A key component of duodenoscope reprocessing is the cleaning step that occurs before high-level disinfection (HLD) or sterilization. Perfect adherence to manufacturer Instructions for Use (IFU) for manual cleaning can be difficult to achieve due to technical complexity and is open to human factor error. Adequate cleaning is measured against FDA and industry maximum allowed contaminants post cleaning of protein<6.4 ug/cm^2 and carbohydrates<2.2 ug/cm^2. Inadequate cleaning increases the risk for inadequate high-level disinfection and the possibility of procedures being performed with contaminated duodenoscopes. A new cleaning process has been developed to fully automate the cleaning step using turbulent flow technology.
Method(s): A total of 48 therapeutic ERCP procedures were performed utilizing Olympus TJF-Q180V duodenoscopes. After bedside point of use cleaning, 21 duodenoscopes were manually cleaned by trained technicians following the manufacturer IFU. 27 duodenoscopes were cleaned using the automated cleaning system. Duodenoscope instrument channels and distal elevator areas were sampled for residual protein and carbohydrates after cleaning.
Result(s): The automated cleaning process resulted in a lower average level of residual protein and carbohydrate compared to standard manual cleaning (Table 1). Using FDA and industry standards as a benchmark, the automated cleaning process reduced levels of protein and carbohydrate below safety threshold levels on all study duodenoscopes, while manual cleaning resulted in 4/21 (19%) duodenoscopes having protein or carbohydrate levels above FDA standards (p= 0.03).
Conclusion(s): Recent outbreaks of MDRO organisms transmitted after ERCP have brought to light the risk to patients when reusable duodenoscopes are not sufficiently reprocessed. The complex design of the device-involving multiple channels and an elevator mechanism at the distal tip-makes proper cleaning difficult. Without sufficient cleaning, subsequent HLD or sterilization can fail to adequately remove contaminants. As seen in this study, manual cleaning can be prone to error. With no incidents of elevated bioburden post cleaning, a fully automated cleaning technology appears to be a viable alternative for replacement of manual cleaning of duodenoscopes

BACKGROUND:Competency in endoscopy has traditionally been based on number of procedures performed. With movement towards milestone-based accreditation, new standards of establishing competency are required. The Thompson Endoscopic Skills Trainer (TEST) is a training device previously shown to differentiate between novice and expert endoscopists. This study aims to correlate TEST scores to other markers of performance in endoscopy. METHODS:Trainees of a gastroenterology fellowship program were guided through the TEST. Their scores and sub-scores were correlated to their endoscopic metrics of performance, including adenoma detection rate, cecal intubation rate, cecal intubation time, withdrawal time, fentanyl usage, midazolam usage, pain score, overall procedure time, and performance on the ASGE Assessment of Competency in Endoscopy Tool (ACE Tool). RESULTS:The Overall Score positively correlated with the ACE Tool Total Score (r = 0.707, p = 0.010) and sub-scores (Cognitive Skills Score: r = 0.624, p = 0.030; Motor Skills Score: r = 0.756, p = 0.004), and negatively correlated with cecal intubation time (r = - 0.591, p = 0.043). The Gross Motor Score positively correlated with cecal intubation rate (r = 0.593, p = 0.042), ACE Tool Total Score (r = 0.594, p = 0.042) and Motor Skills Score (r = 0.623, p = 0.031), and negatively correlated with cecal intubation time (r = - 0.695, p = 0.012). The Fine Motor Score positively correlated with the ACE Tool Polypectomy Score (r = 0.601, p = 0.039), and negatively correlated with procedure time (r = - 0.640, p = 0.025), cecal intubation time (r = - 0.645, p = 0.024), and withdrawal time (r = - 0.629, p = 0.028). CONCLUSION/CONCLUSIONS:This study demonstrates that performance on the TEST correlate to endoscopic measures. Given these results, the TEST may be used in conjunction with existing assessment tools for demonstrating competency in endoscopy.

Background and study aims  The coronavirus disease 2019 (COVID-19), and measures taken to mitigate its impact, have profoundly affected the clinical care of gastroenterology patients and the work of endoscopy units. We aimed to describe the clinical care delivered by gastroenterologists and the type of procedures performed during the early to peak period of the pandemic. Methods  Endoscopy leaders in the New York region were invited to participate in an electronic survey describing operations and clinical service. Surveys were distributed on April 7, 2020 and responses were collected over the following week. A follow-up survey was distributed on April 20, 2020. Participants were asked to report procedure volumes and patient characteristics, as well protocols for staffing and testing for COVID-19. Results  Eleven large academic endoscopy units in the New York City region responded to the survey, representing every major hospital system. COVID patients occupied an average of 54.5 % (18 - 84 %) of hospital beds at the time of survey completion, with 14.5 % (2 %-23 %) of COVID patients requiring intensive care. Endoscopy procedure volume and the number of physicians performing procedures declined by 90 % (66 %-98 %) and 84.5 % (50 %-97 %) respectively following introduction of restricted practice. During this period the most common procedures were EGDs (7.9/unit/week; 88 % for bleeding; the remainder for foreign body and feeding tube placement); ERCPs (5/unit/week; for cholangitis in 67 % and obstructive jaundice in 20 %); Colonoscopies (4/unit/week for bleeding in 77 % or colitis in 23 %) and least common were EUS (3/unit/week for tumor biopsies). Of the sites, 44 % performed pre-procedure COVID testing and the proportion of COVID-positive patients undergoing procedures was 4.6 % in the first 2 weeks and up to 19.6 % in the subsequent 2 weeks. The majority of COVID-positive patients undergoing procedures underwent EGD (30.6 % COVID +) and ERCP (10.2 % COVID +). Conclusions  COVID-19 has profoundly impacted the operation of endoscopy units in the New York region. Our data show the impact of a restricted emergency practice on endoscopy volumes and the proportion of expected COVID positive cases during the peak time of the pandemic.

Background: Lumen-apposing self-expandable metal stents (LAMS) have transformed the management of pancreatic fluid collections over the last two decades. There has since been significant interest in expanding the utility of LAMS for additional therapies such as the management of benign luminal strictures. However, there remains little data on their efficacy and safety when used for this indication. The goal of this study was to define the technical success, clinical success, and complication rates of LAMS when used in the management of benign strictures Methods: This was a retrospective multicenter evaluation of the safety, efficacy, and long-term clinical durability of LAMS in the treatment of benign strictures. The study took place between June 2018 and November 2019. Data collection included demographic information, indication, stent size, use of concurrent balloon dilation including dilation diameter, stent stabilization technique, intra-procedure and post-procedure complications, clinical improvement, and post-procedure follow up outcomes.
Result(s): 30 patients underwent placement of LAMS for a benign luminal stricture, with one having two stents placed during the index procedure at separate areas of stenoses resulting in a total of 31 stents placed. In total, 19 stents were 15 x 10 mm and 12 stents were 20 x 10 mm. No intra-procedural complications were noted. The technical success of deployment was 100%. Clinical resolution of symptoms was present in 25 (83%) patients. Of the patients who experienced clinical improvement, 17 underwent stent removal after an average of 6.4 weeks, and clinical recurrence occurred in 7 (41%) patients. The mean time to recurrence of symptoms after stent removal was 7 weeks. Univariate subgroup analysis revealed 15 x 10 mm stents were associated with clinical improvement (OR 12.86, 95% CI: 1.27-130.57, p 0.031). Each patient who did not clinically improve developed pain (3) or stent migration (2). In total 11 (37%) patients developed minor post-procedure adverse event. Stent migration was seen in 5 (17%) cases. Bleeding and pain were noted in 1 (3%) and 7 (23%) patients, respectively. Ulceration was found in 4 patients.
Conclusion(s): LAMS is a durable, safe option for patients with benign luminal strictures. Overall technical success was 100% and clinical success was 83%. The data also suggests better clinical outcomes with 15 x 10 mm stents, when compared to 20 x 10 mm stents. Pain is the most common adverse event but easily managed. [Formula presented]
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INTRODUCTION: Colonoscopy is the only colorectal cancer screening modality that permits direct visualization of the entire colon and removal of polyps. Low-quality bowel preparation has been associated with lower adenoma detection rates, increased procedure time, and increased hospital cost. An inadequate preparation limits the diagnostic accuracy and overall efficacy of colonoscopy. Factors that contribute to inadequate bowel preparations include age, male sex, inpatient status, low socioeconomic status, low English proficiency, obesity, diabetes, and cirrhosis. We investigated the complex relationship between socioeconomic factors and medical comorbidities on the quality of inpatient colonoscopy preparation.
METHOD(S): We conducted a retrospective chart review of inpatient colonoscopies between October 2017 and April 2019. All patients received a single-dose preparation of polyethylene glycol. We collected data including demographics, medical history, indication, and bowel preparation. A Boston Bowel Preparation Score of 6 or above or an Aronchick score of "good" or "excellent" was used to define an adequate preparation.
RESULT(S): A total of 230 patients were included in the final analysis (Table 1). An inadequate bowel preparation was reported in 16.1% of our inpatient colonoscopies. Within the inadequate preparation group, a greater percentage of patients were male (17.3% vs. 12.3%), had low English proficiency (18.3% vs.15.3%), were not diabetic (17.7% vs.12.3%), and did not have prior bowel surgery (16.4% vs. 0.0%). Within the age, race/ethnicity, and insurance subgroups, patients who were age 80+ (21.4%), Asian-American (25%), unreported race/ethnicity (29.4%), uninsured (25%), and prisoners (22.8%) had a greater percentage of inadequate preparation (Table 2). A logistic regression was performed to assess the effects of age, sex, race/ethnicity, insurance, English fluency, diabetes, restricted mobility, and prior surgery on bowel preparation. The logistic regression model was not statistically significant.
CONCLUSION(S): No significant socioeconomic or medical predictors of bowel preparation were found in this inpatient population which is in contrast to prior literature. While less than 20% of our patient population had inadequate bowel preparation, this is still significant in the broader context of quality, safety, and healthcare costs. Identifying strategies to increase the quality of bowel preparation still remains at the forefront of our field. (Table Presented)

With the development of reliable endoscopic closure techniques and tools, endoscopic full-thickness resection (EFTR) is emerging as a therapeutic option for the treatment of subepithelial tumors and epithelial neoplasia with significant fibrosis. EFTR may be categorized as "exposed" and "nonexposed." In exposed EFTR, the full-thickness resection is undertaken with a tunneled or nontunneled technique, with subsequent closure of the defect. In nonexposed EFTR, a secure serosa-to-serosa apposition is achieved before full-thickness resection of the isolated lesion. This document reviews current techniques and devices used for EFTR and reviews clinical applications and outcomes.