Faculty Bibliography

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.

Introduction Dual endoscopic therapy has been considered the standard of care for endoscopic management of GI bleeding. We aimed to look at the outcomes of Hemospray as a monotherapy treatment for GI bleeds. Methods Data was collected on patients with GI bleeds treated with Hemospray monotherapy in 18 centres. Haemostasis was defined as cessation of bleeding within 5 minutes of hemospray application. Results 62 patients with peptic ulcer bleeds were treated. There was an immediate haemostasis of 90% (56/62), re-bleed rate of 16% (7/44) (Table 1). 69% were Forrest 1a/1b ulcers. 72 patients with malignancy related bleeds. There was a haemostasis rate of 100% and a re-bleed rate of 18% (11/63). There was a haemostasis rate of 100% with post endoscopic therapy bleeds. 48% were post endoscopic mucosal resection. 22 patients with lower GI bleeds were treated. 36% secondary to colonic tumours. There was a haemostasis rate of 96% (21/22) and re-bleed of 26% (5/19). A 100% haemostasis was achieved in 5 patients treated for gastric angiodysplasia with one re-bleed. Conclusions Results show high haemostasis and comparable rebleed rates with Hemospray monotherapy treatment. It may play a potential role in actively bleeding peptic ulcers in difficult anatomical positions to help bridge towards definitive therapy. These data may represent the evolution of new treatment paradigms as experience with haemostatic powders increases

INTRODUCTION/BACKGROUND:Since 2001, device-assisted enteroscopy (DAE) has revolutionized the diagnostic and therapeutic capabilities for managing small bowel pathology. Though commonly performed, there have been no recent large studies to assess the use, yield, and risks of DAE and none that include all 3 DAE modalities. We hypothesized that DAE is safe with high diagnostic and therapeutic yields achieved within reasonable procedure duration and here we present a large retrospective multicenter US study evaluating the use, yield, and complications of DAE. METHODS:After obtaining institutional review board approval, electronic records were used to identify all DAE's performed for luminal small bowel evaluation in adult patients at 4 US referral centers (Duke University Medical Center, New York University Langone Medical Center, Louisiana State University Health Sciences Center, and University of Massachusetts Medical Center) from January 1, 2014 to January 1, 2019. Electronic medical records were reviewed to collect and analyze a variety of procedure-related outcomes. Using the data pooled across centers, descriptive statistics were generated for the patient and procedure-related characteristics and outcomes; relationships between characteristics and outcomes were explored. RESULTS:A total of 1787 DAE's were performed over this 5-year period (392 at Duke University Medical Center, 887 at Louisiana State University Health Sciences Center, 312 at New York University Langone Medical Center, and 195 at University of Massachusetts Medical Center). Of these, there were 1017 (57%) double-balloon, 391 (29%) single-balloon, and 378 (21%) spiral enteroscopies. The mean age of patients undergoing DAE was 66 years and 53% of examinations were performed on women; 18% of patients in the cohort underwent >1 DAE over this time span. A total of 53% of examinations were performed for suspected small bowel bleeding, 31% were directly guided by video capsule endoscopy findings and 8% were performed for abnormal imaging. A total of 85% of examinations used an antegrade approach and DAE took a mean of 45 minutes to complete; 76% of examinations revealed abnormal findings, with vascular, inflammatory, and neoplastic findings seen in 49%, 17%, and 15% of the cohort, respectively. Older age was significantly associated with any abnormal finding, including arteriovenous malformations (P<0.0001); 50% of examinations included a therapeutic maneuver, most commonly argon plasma coagulation/cautery (43%). There were complications in 16 examinations (0.9%) including 2 perforations (0.1%), 6 cases with bleeding (0.3%) and 1 episode of pancreatitis (0.1%). CONCLUSIONS:DAE is most commonly performed to evaluate suspected small bowel bleeding and is commonly directed by video capsule findings. DAE is safe, has a high diagnostic yield, with 76% of examinations showing abnormal findings, and frequently features therapeutic maneuvers. Advancing age is associated with abnormal findings on DAE.

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: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.

Introduction: Missed adenomas during screening and surveillance colonoscopy are considered a leading cause of interval colorectal cancer (CRC). Numerous technologies were developed to assist in visualization of the mucosal surface and particularly the proximal aspect of haustral folds, consisting of either rear-viewing optics or mechanical manipulation of colon folds. Recent studies demonstrate superiority in increasing adenoma detection rate (ADR) of mechanical fold manipulation over rearview optical visualization, by two mechanical attachments at the distal tip of the colonoscope (Figure 1) - the Endocuff Vision single-use disposable attachment (ECV, Olympus Corporation, Japan) and the G-EYE permanently-mounted reusable and reprocessable balloon (G-EYE, Smart Medical Systems, Israel). The ECV is placed on the colonoscope tip prior to insertion, and is designed to expand radially during withdrawal, thereby allowing manipulation of folds. The G-EYE balloon is deflated during insertion, inflated at the cecum, engaging the colon wall and flattening colon folds during withdrawal, while centralizing colonoscopic view.
Method(s): Randomized, prospective, multicenter study, patients referred to screening or surveillance colonoscopy were randomized to undergo either ECV or G-EYE colonoscopy. A 1:1 randomization ratio between ECV and G-EYE colonoscopy was done. Polyps were removed, sent for pathology and analyzed, to determine the adenoma detection rate (ADR) and adenoma per patient (APP) in each group.
Result(s): 727 enrolled patients out of planned 970 (485 in each group) are presented (Table 1), 364 in the ECV group and 363 in the G-EYE group. Patient characteristics were similar in both groups. Withdrawal times were above the recommended 6-minute guideline threshold and similar in both arms. ADR in the G-EYE arm was 9.8% higher (relative increase 19.1%) than in the ECV arm, and the detection of advanced adenomas was doubled (24% versus 12%). The number of adenomas per patient was significantly higher for G-EYE colonoscopy, particularly the number of advanced and large adenomas.
Conclusion(s): This randomized trial is the first head to head comparison of these mechanical enhancement colonoscopy devices. In this present study G-EYE (preliminary analysis) demonstrated meaningful increase in ADR over ECV, particularly for advanced adenomas, as well as substantial increase in APP

Introduction: Colorectal cancer is the third most common cancer for both men and women1. Despite the effectiveness of colon cancer screening only 44% of eligible patients get screened. Often related to not wanting an invasive procedure or not wanting to be sedated. Current non-invasive option include stool based tests, pillcam colon and CT colonography, both requiring a bowel cleanse. Recently there is a new x-ray capsule, which does not require a bowel cleanse prior to ingestion. The case below shows the correlation between x-ray capsule and optical colonoscopy for colon polyp detection. Case Description/Methods: A 55 year old male with no significant medical problems present for colon cancer screening. He has no family history of colon cancer or polyps. He denies any gastrointestinal complaints. Prior to undergoing colonoscopy, the patient ingests the x-ray capsule, using ultra-low dose x-ray imaging 3-dimensional (3D) images of the colon are created. This is accomplished without needing a bowel cleanse. Scans are taken during capsule motion in the colon and transmitted data to an external recorder unit attached to the patients' lower back. Using both data colon scans and the capsule position tracking a reconstructed 3D colon segments are generated. A 10 mm polyp was identified in the ascending colon. A subsequent colonoscopy was performed identifying the lesion, which was removed by snare polypectomy (Figure 1).
Discussion(s): Colon cancer screening has decreased the mortality of colon cancer. Colonoscopy is the gold standard, but some patients prefer non-invasive option. X-ray capsule is able to achieve 3D imaging using ultra low dose radiation. Future studies are needed to determine of this technology will play a role in colon cancer screening

Introduction: Endoscopic ultrasound (EUS with fine needle aspiration (FNA) is often used to evaluate solid tumors of the pancreas. However, fine needle biopsy (FNB) offers a histologic sample versus a disaggregated sample seen in FNA. Even with FNB technique can limit sample quality. All current needles are manually operated. However, there is a novel motorized FNB needle offering a rotational axial motion resulting in an intact core. This case demonstrates the use of a motorized FNB needle for tissue sampling during EUS. Case Description/Methods: A 87 F presents for the work up of abdominal pain and weight loss. She has no significant medical problems. A cat scan of the abdomen and pelvis was ordered revealing a 3.5 cm mass in the body of the pancreas, concerning for neoplasm. The patient was sent for EUS with biopsy for tissue diagnosis. During the EUS exam a 19g motorized FNB needle was used. After the needle is passed into the tumor a button on the needle shaft is pressed. The needle begins to rotate using an electro mechanical axial motion cutting into the tumor to obtain a specimen. A single pass was required, which confirmed a ductal adenocarcinoma of the pancreas. Due to the vascular invasion the patient was sent to oncology for further management.
Discussion(s): Cancer management continuous to move in the direction of precision medicine. A tissue biopsy is needed to have intact histology sample for diagnosis of a malignant tumor. Furthermore, biopsy is needed to allow molecular analysis of the tumor to offer a personalized treatment plan. This is the first reported case of a motorized EUS needle for tissue acquisition. Future studies are needed to assess performance against traditional manual EUS needles

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: 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