Faculty Bibliography

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

Introduction: Obtaining core biopsies using endoscopic ultrasound-guided fine-needle biopsy (EUSFNB) needles for histological diagnosis and tumor molecular profiling is needed in the era of precision medicine. However, sample quality is impacted by several factors; needle type, number of passes and technique. Currently, all available biopsy needles are manually operated. A new motorized endoscopic ultrasound electro-mechanical revolving needle has been developed to standardize and improve tissue acquisition. This unique cutting needle design along with the rotation-axial motion produces smooth tissue cutting and intact core-tissue quality, without crushing the samples. The combination of the axial and the rotational movements enables efficient and smooth tissue cutting, producing better core-tissue quality and volume. The study is the first to compare a motorized approach to traditional manual technique.
Method(s): Patients with solid pancreas tumors or lymphadenopathy were eligible for enrollment. Each patient had the lesion sampled by both motorized needle (19g) and manual needle (Sharkcore), 22g, biopsy method. The study was approved by the IRB. Procedure measures included; number of passes, diagnostic yield, and histologic scores. Microscopic grading scale of the histological quality of the specimen from 1 to 5 scale (1 =poor, non-diagnostic yield) to 5 (excellent, completely diagnostic yield).
Result(s): Ten patients were enrolled, 7males and 3 females, with an average age of 71 years old. There were 9 pancreas tumors with an average size of 30 mm and one lymph node (30mm). The average number of passes was 1 in motorized group compared to 1.5 in manual group. The diagnostic yield was similar in both arms. However, histologic scores and ability for molecular profiling was higher in the automated group at 100% and 96% compared to 73% and 60% in the manual group (Figure 1).
Conclusion(s): FNB is the method of choice for tumor acquisition. The initial results of this study suggest an automated motorized needle biopsy approach may lead to more consistent histologic quality along with the ability for molecular profiling of tumors with fewer passes. Future larger studies are need to validate these findings. This is the first human feasibility trial using a motorized needle during endoscopic ultrasound

Introduction: Looping is a primary barrier to safe and efficient colonoscopy. Common methods to address looping include staff-applied manual pressure and patient repositioning. These techniques are used frequently (52% and 34% of colonoscopies, respectively) yet are variably effective and can cause musculoskeletal disorders (MSDs) in endoscopy staff. A recent study demonstrated an association between manual pressure and post-procedure musculoskeletal pain in endoscopy personnel. Risk was maximized when long-duration pressure (> 3 min) was needed in obese patients (BMI> 30). ColoWrap (ColoWrap, LLC, Durham, NC) is an anti-looping compression device applied during colonoscopy to decrease insertion time and the need for manual pressure and patient repositioning. We aimed to determine the extent to which the device reduces the need for manual pressure and repositioning relative to published rates.
Method(s): This retrospective, multi-center, observational chart review included patients that underwent colonoscopy with the ColoWrap device between July 28, 2016 and November 11, 2020.The primary outcome was use of manual pressure. Secondary outcomes included the use of manual pressure for> 3 minutes and the use of patient repositioning.
Result(s): 392 procedures were included in the review. The population was predominantly male (61%), over 60 (mean age: 62.4+/-10.2), and obese (mean BMI: 33.4+/-8.2). 29 patients (7.4%) presented with an abdominal hernia. 65 (16.6%) had at least one prior abdominal surgery. Propofol sedation was used in the majority (59%) of procedures. Cecal intubation was achieved in 392 cases (100%). Mean cecal intubation time was 6.3+/-5.1 (min). Manual pressure was required in 39 cases (9.9%) and only 6 procedures (1.5%) required manual pressure for> 3 min. Patient repositioning was required in 22 cases (5.6%). In a sub-population analysis of obese patients with BMI> 35 (n=134), manual pressure was required in 10 procedures (7.5%); 2 procedures (1.5%) required manual pressure> 3 min and 5 procedures (3.7%) needed patient repositioning.
Conclusion(s): Use of the ColoWrap colonoscopy compression device significantly reduced the use of manual pressure and patient repositioning relative to published rates. The device essentially eliminated the need for long-duration manual pressure and was comparably effective in obese patients with BMI> 35

Leaving no significant polyp behind while avoiding risks due to unnecessary resections is a commonsense strategy to safely and effectively prevent colorectal cancer (CRC) with colonoscopy. It also alludes to polyps worth removing and, therefore, worth finding. The majority of "worthy" precancerous polyps are adenomas, which for over 2 decades, have received the most attention in performance research and metrics. Consequently, the detection rate of adenomas is currently the only validated, outcome-based measure of colonoscopy demonstrated to correlate with reduced risk of postcolonoscopy CRC. However, a third or more of postcolonoscopy CRCs originate from sessile serrated polyps (SSPs), which are notoriously difficult to find, diagnose and completely resect. Among serrated polyps, the agreement among pathologists differentiating SSPs from non-neoplastic hyperplastic polyps is moderate at best. This lack of ground truth precludes SSPs from consideration in primary metrics of colonoscopy quality or performance of novel polyp detection technologies. By instead leveraging the distinct endoscopic and clinical features of serrated polyps, including those considered important due to proximal location and larger size, clinically significant serrated polyps represent serrated polyps worth removing, enriched with subtle precancerous SSPs. With the explosion of technologies to assist polyp detection, now is the time to broaden benchmarks to include clinically significant serrated polypss alongside adenomas, a measure that is relevant both for assessing the performance of endoscopists, and for assessing new polyp detection technologies.

BACKGROUND AND AIM/OBJECTIVE:Upper gastrointestinal tumors account for 5% of upper gastrointestinal bleeds. These patients are challenging to treat due to the diffuse nature of the neoplastic bleeding lesions, high rebleeding rates, and significant transfusion requirements. TC-325 (Cook Medical, North Carolina, USA) is a hemostatic powder for gastrointestinal bleeding. The aim of this study was to examine the outcomes of upper gastrointestinal bleeds secondary to tumors treated with Hemospray therapy. METHODS:Data were prospectively collected on the use of Hemospray from 17 centers. Hemospray was used during emergency endoscopy for upper gastrointestinal bleeds secondary to tumors at the discretion of the endoscopist as a monotherapy, dual therapy with standard hemostatic techniques, or rescue therapy. RESULTS:One hundred and five patients with upper gastrointestinal bleeds secondary to tumors were recruited. The median Blatchford score at baseline was 10 (interquartile range [IQR], 7-12). The median Rockall score was 8 (IQR, 7-9). Immediate hemostasis was achieved in 102/105 (97%) patients, 15% of patients had a 30-day rebleed, 20% of patients died within 30 days (all-cause mortality). There was a significant improvement in transfusion requirements following treatment (P < 0.001) when comparing the number of units transfused 3 weeks before and after treatment. The mean reduction was one unit per patient. CONCLUSIONS:Hemospray achieved high rates of immediate hemostasis, with comparable rebleed rates following treatment of tumor-related upper gastrointestinal bleeds. Hemospray helped in improving transfusion requirements in these patients. This allows for patient stabilization and bridges towards definitive surgery or radiotherapy to treat the underlying tumor.

BACKGROUND:High quality bowel preparation prior to colonoscopy can be difficult to achieve in the inpatient setting. Hospitalized patients are at risk for extended hospital stays and low diagnostic yield due to inadequate bowel preparation. The Pure-Vu System is a novel device intended to fit over existing colonoscopes to improve intra-colonoscopy bowel preparation. The objective of the REDUCE study was to conduct the first inpatient study to evaluate optimization of bowel preparation quality following overnight preparation when using the Pure-Vu System during colonoscopy. METHODS:This multicenter, prospective feasibility study enrolled hospitalized subjects undergoing colonoscopy. Subjects recorded the clarity of their last bowel movement using a 5-point scale prior to colonoscopy. After one night of preparation, all enrolled subjects underwent colonoscopy utilizing the Pure-Vu System. The primary endpoint was improvement of colon cleanliness from baseline to post-cleansing with the Pure-Vu System as assessed by the improvement in Boston Bowel Preparation Scale (BBPS). An exploratory analysis was conducted to assess whether the clarity of the last bowel movement could predict inadequate bowel preparation. RESULTS:Ninety-four subjects were included. BBPS analyses showed significant improvements in bowel preparation quality across all evaluable colon segments after cleansing with Pure-Vu, including left colon (1.74 vs 2.89; p < 0.0001), transverse colon (1.74 vs 2.91; p < 0.0001), and the right colon (1.41 vs 2.88; p < 0.0001). Prior to Pure-Vu, adequate cleansing (BBPS scores of ≥ 2) were reported in 60%, 62%, and 47% for the left colon, transverse colon, and right colon segments, respectively. After intra-colonoscopy cleansing with the Pure-Vu System, adequate colon preparation was reported in 100%, 99%, and 97% of the left colon, transverse colon, and right colon segments, respectively. Subjects with lower bowel movement clarity scores were more likely to have inadequate bowel preparation prior to cleansing with Pure-Vu. CONCLUSIONS:In this feasibility study, the Pure-Vu System appears to be effective in significantly improving bowel preparation quality in hospitalized subjects undergoing colonoscopy. Clarity of last bowel movement may be useful indicator in predicting poor bowel preparation. Larger studies powered to evaluate clinical outcomes, hospital costs, and blinded BBPS assessments are required to evaluate the significance of these findings. Trial registration Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System (NCT03503162).

BACKGROUND AND AIM/OBJECTIVE:Recently, the BLI Adenoma Serrated International Classification (BASIC) system was developed by European experts to differentiate colorectal polyps. Our aim was to validate the BASIC classification system among the US-based endoscopy experts. METHODS:Participants utilized a web-based interactive learning system where the group was asked to characterize polyps using the BASIC criteria: polyp surface (presence of mucus, regular/irregular and [pseudo]depressed), pit appearance (featureless, round/non-round with/without dark spots; homogeneous/heterogeneous distribution with/without focal loss), and vessels (present/absent, lacy, peri-cryptal, irregular). The final testing consisted of reviewing BLI images/videos to determine whether the criteria accurately predicted the histology results. Confidence in adenoma identification (rated "1" to "5") and agreement in polyp (adenoma vs non-adenoma) identification and characterization per BASIC criteria were derived. Strength of interobserver agreement with kappa (k) value was reported for adenoma identification. RESULTS:Ten endoscopy experts from the United States identified conventional adenoma (vs non-adenoma) with 94.4% accuracy, 95.0% sensitivity, 93.8% specificity, 93.8% positive predictive value, and 94.9% negative predictive value using BASIC criteria. Overall strength of interobserver agreement was high: kappa 0.89 (0.82-0.96). Agreement for the individual criteria was as follows: surface mucus (93.8%), regularity (65.6%), type of pit (40.6%), pit visibility (66.9%), pit distribution (57%), vessel visibility (73%), and being lacy (46%) and peri-cryptal (61%). The confidence in diagnosis was rated at high ≥4 in 67% of the cases. CONCLUSIONS:A group of US-based endoscopy experts hsave validated a simple and easily reproducible BLI classification system to characterize colorectal polyps with >90% accuracy and a high level of interobserver agreement.

GOAL/OBJECTIVE:This meta-analysis aims to compare the sessile-serrated adenoma detection rate (SSADR) of currently available mechanical new technology devices (NTDs) to conventional colonoscopy (CC). BACKGROUND:NTDs including Endocuff, EndoRing, G-Eye, and AmplifEYE were developed with the aim of improving adenoma detection rate by enhancing colonic mucosal visualization. Increasing awareness of the risk of sessile-serrated adenoma progression to malignancy has ushered a need to increase the detection of these characteristically flat lesions. STUDY/METHODS:Embase and PubMed/Medline databases were searched from inception through January 2019 for published manuscripts or major conference abstracts reporting SSADR with Endocuff, EndoRing, G-Eye, AmplifEYE, and CC. Randomized controlled trials, high-quality case-control, cohort, and observational studies in adults with >10 subjects were included. The primary outcome was pooled SSADR odds ratio (ORs) with 95% confidence interval (95% CI) comparing CC with the NTDs. In addition, an analysis comparing each device to CC was performed. RESULTS:Of 207 citations identified, a total of 14 studies with 12,655 subjects were included in our analysis (5931 subjects with NTDs and 6724 with CC). There were 12 studies with Endocuff, 2 with EndoRing, 1 with G-EYE, and 1 with AmplifEYE. The mean age was 62.4 years and 57.5% were males. Pooled SSADR with NTDs was 12.3% as compared with 6.4% with CC, with an OR of 1.81 (95% CI: 1.6-2.0, I2: 77%). Analysis of Endocuff alone yielded an OR 1.81 (95% CI: 1.6-2.1, I2: 79%). CONCLUSION/CONCLUSIONS:Mechanical NTDs, notably Endocuff, are a safe and effective tool to increase the SSADR.