Faculty Bibliography

Introduction: EUS-guided FNA and FNB have established their place for tissue acquisition. However, the procedure has been stagnating in recent years at a level of accuracy which falls short of patient and physician hopes. In recent years, needles have been redesigned to allow for core sampling, (FNB), to allow for immune-staining of specimens. However, false negative results for malignancy range from 4% (experts centers) to 30%. Multiple needle passes are often needed, but often slide along the same tract as the first pass, limiting diagnostic yield. An FNA approach usually requires 3-5 passes, with fewer passes for the FNB needles. Furthermore, rapid on-site cytology can lower number of passes, but the majority of centers find this to be logistically and/or financially prohibitive. Needles after repeated passes bend out of shape leading to use of a second needle, which has cost implications. Tumor composition can be a mosaic of desmoplasia, necrosis, cystic areas, and malignant cells. If the needle is in the wrong plane and the endoscopist is unable to do fanning an inconclusive diagnosis can occur. We introduce a new needle concept to improve diagnostic yield and lower false negatives, with use of a device which has five needles. Aims & Methods : A multi-pass needle has been designed which ensures five specimens will be from various sites, because the five needles are all penetrating at the same time in different planes of the lesion. This needle apparatus uses the same sheath as a standard 19 gauge needle, but within the sheath it houses a five-lumen plastic tube, which separates between the central 22g needle and the four peripheral 25g needles. The ergonomically- designed handle has a two-phase mechanism which allows the endoscopist to first place the 22g needle within the target lesion, which is the same as the process done today, and to then extrude the four 25g needles, which are pre-bent so as to spread out to a diameter of about one cm at a distance of about 3cm from the scope. These additional needles will each, without fanning, obtain specimens near to the central needle, and therefore a greater representation of tumor tissue will be obtained, while completing the procedure in one pass, with better accuracy due to less false negatives. The two channels for suction can be attached to either the single central needle and/or to all four peripheral needles with stopcocks facilitating the maintaining of suction when so desired. Each needle has its own stylet, these may be removed at any time desired.
Result(s): We present in the accompanying figure the InstaFan, a disruptive technological advance, for the delivery of better EUS biopsies. Ex vivo studies found that the 5 needles did not cause leakage from the gut or perforation of the gut wall, and that the 5 needles delivered resulted in five distinct specimens each of which was an adequate specimen for pathological diagnostic purposes using the cell block method and paraffin slices allowing immune-staining.
Conclusion(s): Future directions of the InstaFan will be animal in vivo animal safety study followed by first trials in humans. The goal of the InstaFan will be to reduce false negatives, thus increasing optimization of tumor diagnosis

INTRODUCTION: Screening for Barrett's Esophagus (BE) in chronic gastroesophageal reflux disease (GERD) using targeted and random forceps biopsy (FB) is recommended by current ACG guidelines. A recent study of 10,412 screening patients showed that Wide Area Transepithelial Sampling with 3D computer-assisted tissue analysis (WATS) increases detection of Barrett's esophagus (BE) when used adjunctively to FB. We analyzed the cost-effectiveness implications of this study's findings.
METHOD(S): A decision analytic model compared the effectiveness and cost-effectiveness of two alternative screening strategies for BE in chronic GERD patients: FB alone vs. FB combined with WATS. The reference case was a 60 year old male. BE detected by positive FB or WATS was referred for surveillance. False positive WATS+/FB- were confirmed after a second negative surveillance FB. Cost and effectiveness of surveillance were based on published models with ablation for low or high grade dysplasia, available on the National Cancer Institute CISNET website. See Table 1 for an overview of model parameters. Effectiveness was measured in quality-adjusted life years (QALYs). Cost was measured in 2018 US$ and the incremental cost-effectiveness ratio (ICER) was measured in $/QALY. Model parameters are outlined in Table 2. We considered 3 values of added yield (213% from the study, half of that, one-third of that) and 3 values of false positives among the added yield (5%, 15%, 25%) and calculated the ICER for all 9 pairwise combinations of those two parameters. We considered two thresholds for cost-effectiveness: $100K/QALY and $150K/QALY. Cost and QALYs were discounted at 3% per year.
RESULT(S): The ICERs for all 9 combinations of added yield and false positives are in Table 3. Use of FB plus WATS was cost-effective in all 9 combinations at the lower $100K/QALY threshold. Using the worst case for added yield (1/3 of the value from the study), FB plus WATS was cost-effective at the $150K/QALY for a false positive rate below 56%. Using the worst case for false positive rate (25%), FB plus WATS was cost-effective at the $150K/QALY for added yield of over 38%.
CONCLUSION(S): We demonstrate that WATS, when used adjunctively with FB for screening 60 year old males with chronic GERD, is a cost-effective approach to reducing morbidity and mortality from esophageal cancer

INTRODUCTION: Missed lesions are considered a major cause of interval cancer of the colon. The new Automatic Polyp Detection System (APDS) from Magentiq Eye was developed to enhance the ability of endoscopists to detect polyps. It is designed for offline use with future real-time applications. The system uses recorded colonoscopy videos to assess endoscopist performance against the APDS. The APDS reviews the videos to generate a computerized automatic signature of polyps; a separate screen then shows the corresponding ?heat map' contour of areas suspicious for presence of polyps (see Figure 1).
METHOD(S): In this proof-of-concept study, the performance of the trained system was compared with a known testing database of 35 videos (each sequence approximately 30 seconds and 1000 frames). Overall, the testing database included 35,290 frames, with polyps found in the right colon (cecum and ascending colon, 10), transverse colon (5), and left colon (sigmoid and rectum, 20). Of the 35, 33 polyps were sessile and 2 were pedunculated; sizes ranged from less than 3 mm (10), 3 to 6 mm (16), 6 to 10 mm (5), and over 10 mm (4). Our goal was to define the optimal system working point in terms of sensitivity and specificity to detect polyps present in at least 3 consecutive frames. Physicians reviewed videos for polyps that were missed by the APDS and compare it with those missed by the endoscopists.
RESULT(S): The best working point of the system showed 88% sensitivity with 98.4% specificity (0.016 false positive rate). This resulted in a system polyp detection rate (SPDR) of 85.8% with 5 missed polyps. Missed lesions were found in the ascending (2), transverse (2), and descending (1) colon. All were sessile with sizes of less than 3 mm (1), 3 to 6 mm (3), 6 to 10 mm (1). The physicians missed 4 polyps found in the transverse colon (3) and descending colon (1). All polyps missed by physicians were sessile with sizes of less than 3 mm (1), 3 to 6 mm (2), and 6 to 10 mm (1). Only one polyp was missed both by the APDS and the physician.
CONCLUSION(S): Given that only one polyp was missed both by the APDS and the endoscopists, the APDS demonstrated the potential to behave as a complementary tool during colonoscopy in order to alert the endoscopist to lesions that may otherwise be missed, aiming to decrease the incidence of interval colon cancers

INTRODUCTION: Wide Area Transepithelial Sampling with 3-Dimensional Computer-Assisted Analysis (WATS) when used adjunctively to forceps biopsies (FB) has been demonstrated in multiple prospective studies to significantly increase detection of Barrett's esophagus (BE) and associated neoplasia in patients undergoing either BE screening or surveillance. The clinical impact ofWATS positive-FB negative diagnoses has never been evaluated. The aim of this IRB-approved clinical utility study was to determine changes in patient management when BE and/or dysplasia was detected by WATS but not by FB.
METHOD(S): Between 2013-2018, we identified 423 consecutive patients from WATS clinical registries who had a WATS positive diagnosis of BE or dysplasia and a negative FB result; 317 patients were diagnosed with BE, 90 with low grade dysplasia (LGD) and 16 with high grade dysplasia (HGD) by WATS only. Physicians subsequently completed an extensive survey to determine if the positive WATS diagnosis resulted in a change in patient management such as enrolment in a surveillance program, endoscopic ablation/antireflux surgery, initiating proton pump inhibitors (PPIs) or increasing the patient's dose of PPI.
RESULT(S): The clinical impact of WATS positive-FB negative diagnoses for patients with BE, LGD or HGD is summarized in Table 1. WATS had a direct impact on the clinical management of 97.8% of the 317 BE patients including enrolment in a surveillance program (96.2%), ablation/antireflux surgery (3.7%), or starting or increasing the dose of PPIs (60.2%). WATS impacted the management of 94.4% and 93.7% of LGD and HGD patients respectively. For instance, 30% and 50% respectively had ablation, 73.3% and 68.8% had increased frequency of or new enrollment in surveillance, and 56.7% and 62.5% had PPIs prescribed or the dose increased. Seven of 8 HGD patients not ablated were lost to follow up. One of 8 HGD patients not ablated developed invasive adenocarcinoma also identified with WATS upon follow-up endoscopy.
CONCLUSION(S): The results of this study demonstrate that physicians have a high degree of confidence in WATS diagnoses even when the concurrent FB is negative. This is evidenced by the fact that physicians changed their patient management in 96.9% of all cases, often significantly with invasive treatments such as ablation, EMR, and even antireflux surgery in a small %age of patients. As an adjunct to FB, WATS has high clinical utility and adds value to the management of patients with BE and associated dysplasia

INTRODUCTION: Meckel's diverticulum (MD) is the most common congenital malformation of the gastrointestinal (GI) tract, present in 2-4% of the population. Typically, it presents as GI bleeding and is usually diagnosed in childhood. However, some patients may remain asymptomatic through adulthood or present later in life with complications. We describe an unusual case of an adult male presenting with abdominal pain and maroon stools, who underwent an extensive workup and was eventually diagnosed with MD only after a double-balloon enteroscopy (

INTRODUCTION: Colorectal cancer remains the second leading cause of cancer death in the world. Incidence has declined as rates of screening colonoscopy have increased, but colonoscopy is not perfect. Low adenoma detection rates (ADR's) have been associated with increased interval cancers. Both optical and mechanical devices for improving ADR have shown promising results. Here we demonstrate a novel colonoscope with a 360degree integrated view to improve visualization behind folds (Figure 1). The aim of this study is to compare polyp detection rates using the novel 360degree scope and a standard forward only view (FOV) scope in colon models.
METHOD(S): 324 endoscopists around the US were enrolled in the study. 20 anatomic colon models (Champerlain Group, Great Barrington, MA) containing simulated 6-15 mm polyps were used. Polyps varied in number, location, and shape. Models were examined in a tandem fashion with the 360degree scope and the FOV scope. Endoscopists were randomly assigned to perform the initial exam with either scope. The primary outcome was the number of polyps identified during withdrawal. Subgroup analysis was performed evaluating effects of order of examination, experience, and practice setting. Means were compared with a paired T-test and subgroups were compared with ANOVA.
RESULT(S): 153 endoscopists performed their initial exam with the 360degree scope, and 171 with the FOV scope. The 360degree view colonoscope identified significantly more polyps overall (13.2 vs 7.7, mean difference 5.5, P< 0.0001). Each individual endoscopist identified more polyps with the 360degree scope. The difference persisted regardless of which scope was used first. The difference also persisted between endoscopists of different experience and practice environments (Table 1). The only statistically significant difference was between endoscopists stratified by years of training, in which the <5 year group had a larger difference in polyp detection (P=0.0006).
CONCLUSION(S): This study shows that the 360degree integrated view colonoscope is more effective at polyp detection than a traditional colonoscope in simulated models. The increased polyp detection is not dependent on experience level or practice environment. The expanded field of view allows endoscopists to identify polyps that may be missed by a traditional scope such as behind folds. Further studies in humans will be needed to prove safety/efficacy for clinical use but these initial results show promise for increasing ADR using this novel colonoscope (Figure Presented)

Background: Good colon preparation is critical for ensuring high quality optical colonoscopy (OC). Hospitalized patients are at high risk for inadequate colon preparation for OC due to comorbidities, medication use and debilitated status. Inadequate colon preparation leads to delayed, aborted and rescheduled procedures resulting in prolonged hospitalizations and increased costs. The Pure Vu System is a novel device intended to fit over existing colonoscopes to facilitate intraprocedural cleansing of the colon by simultaneously irrigating and evacuating bowel content.
Method(s): This multicenter, prospective, single-arm study (sponsored by Motus GI)anticipates enrolling up to 100 hospitalized patients to evaluate the Pure-Vu System following standard bowel preparation. This interim analysis summarizes the results of the initial 45 patients enrolled. Upon consenting, patients were consecutively enrolled regardless of the bowel preparation condition and the procedure was performed with the Pure-Vu System. The primary endpoint was improvement of colon cleansing from baseline to post procedure as assessed by the improvement in Boston Bowel Preparation Scale (BBPS)following cleansing with Pure-Vu System Secondary endpoints were rate of patients with successful colonoscopy for the intended indication in the first attempt and safety.
Result(s): Forty-five hospitalized patients (62% males), mean age 63.1 years and mean BMI of 27.1 kg/m² were included in the analysis. The predominate indication for OC was GI bleeding (62%)(Table 1). In 36 (80%)patients, the physician was able to successfully diagnose in the first attempt per the patients' indication. In these patients, adequate bowel cleansing (BBPS>=2 in each segment that were visualized)was improved from 39% at baseline to 100% after cleansing with the Pure-Vu System. There was one procedure related perforation which required surgical repair, the patient was discharged 48 hours post operatively and fully recovered.
Conclusion(s): Bowel preparation for hospitalized patients remain a significant challenge resulting in delayed/cancelled procedures, missed pathology and increased costs of care. Although a small subset, this first U.S. multicenter study investigates a population that poses the most challenging medical circumstances. One of the limitations of this study is unavailability of the Pure-Vu system compatible with Slim (pediatric)colonoscopes; in 4 of the 9 cases where a conclusive diagnosis could not be obtained, a Slim scope was used to complete the procedure. The Pure-Vu system cleanses the colon intraprocedurally and may improve the efficacy and prevent a delayed or repeat OC procedure. This preliminary analysis demonstrates an increase in the BBPS score following the use of the Pure-Vu System, but more importantly, it demonstrates an increase in colon cleansing adequacy to reach successful diagnosis. [Figure presented][Figure presented]
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The 4-quadrant forceps biopsy (FB) protocol for identifying Barrett's esophagus (BE) and esophageal dysplasia (ED) suffers from poor sensitivity due to significant sampling error. We investigated the benefit of wide-area transepithelial sampling with 3-dimensional computer-assisted analysis (WATS) used adjunctively to the combination of random and targeted FB in the detection of ED, and as a secondary outcome, BE. In this multicenter prospective trial, community endoscopists at 21 sites utilized WATS as an adjunct to both targeted and random FB in patients undergoing BE screening and surveillance. Investigators alternated taking FB and WATS samples first. WATS specimens were analyzed at CDx Diagnostics (Suffern, NY) while FB samples were analyzed by each site's regular pathologists. Data were de-identified and then aggregated for analysis. Of 12,899 patients enrolled, FB identified 88 cases of ED, and WATS detected an additional 213 cases missed by FB. These 213 cases represented an absolute increase of 1.65%, raising the yield from 0.68% to 2.33%. Adding WATS to FB increased the overall detection of ED by 242% (95% CI: 191%-315%). Fewer than 61 patients needed to be tested with WATS to identify an additional case of ED. The combination of random and targeted FB identified 1,684 cases of BE, and WATS detected an additional 2,570 BE cases. The absolute incremental yield of adding WATS to FB is 19.9%, increasing the rate of detection from 13.1% to 33%. Adding WATS to FB increased the overall detection of BE by 153% (95% CI: 144-162%). The number needed to test with WATS in order to detect an additional case of BE was 5. Whether FB or WATS was done first did not impact the results. In this study, comprised of the largest series of patients evaluated with WATS, adjunctive use of the technique with targeted and random FB markedly improved the detection of both ED and BE. These results underscore the shortcomings of FB in detecting BE-associated neoplasia, which can potentially impact the management and clinical outcomes of these patients.

BACKGROUND:Colorectal cancer (CRC) is largely preventable with routine screening and surveillance colonoscopy; however, interval cancers arising from precancerous lesions missed by standard colonoscopy (SC) still occur. Increased adenoma detection rate (ADR) has been found to be inversely associated with interval cancers. The G-EYE device comprises a reusable balloon integrated at the distal tip of a standard colonoscope, which flattens haustral folds, centralizes the colonoscope's optics and reduces bowel slippage. The insufflated balloon also aims to enhance visualization of the colon during withdrawal, thereby increasing ADR. METHODS:In this randomized, controlled, international, multicenter study (11 centers), subjects (age ≥50) referred to colonoscopy for screening, surveillance, or due to changes in bowel habits, were randomized to undergo either balloon-assisted colonoscopy using an insufflated balloon during withdrawal or standard high-definition colonoscopy. Primary endpoint was ADR. RESULTS:One thousand subjects were enrolled between May 2014 and September 2016 to undergo colonoscopy by experienced endoscopists; 803 were finally analyzed (SC: n=396; balloon-assisted colonoscopy: n=407). Baseline parameters were similar in both groups. Balloon-assisted colonoscopy provided a 48.0% ADR compared with 37.5% in the SC group (28% increase, p=0.0027). Additionally, balloon-assisted colonoscopy provided for a significant increase in detection of advanced (p=0.0033), flat adenomas (p<0.0001), and sessile serrated adenoma/polyp (SSA/Ps) (p=0.0026). CONCLUSIONS:Balloon-assisted colonoscopy yielded a higher ADR and increased the detection of advanced, flat and SSA/Ps when compared with SC. Improved detection by the G-EYE device could impact the quality of CRC screening by reducing miss rates, and consequently reducing of interval cancers incidence; clinicaltrials.gov (NCT01917513).