Faculty Bibliography

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: Combination endoscopic therapy is considered a gold standard treatment of upper gastrointestinal bleeding (UGIB). Endoscopic therapy reduces mortality in these patients. Hemospray is a haemostatic powder used for the endoscopic treatment of GI bleeds. We aimed to analyse the outcomes of Hemospray therapy in combination with standard endoscopic treatments. Aims & Methods: Data was collected on consecutive patients with GIB's and treated with Hemospray as part of a combination with standard endoscopic treatments from 18 centres (USA, UK, France, Germany, Spain). The decision to use Hemospray and what combination to use was at the discretion of the endoscopist.
Result(s): We analysed the outcomes of 230 patients (UGIB's - 134 peptic ulcers, 37 post endoscopic therapy, 29 UGI malignancies, 7 variceal, 6 angiodysplasia, 2 inflammation, 15 lower GI bleeds) (Table 1). 134/267 (50%) of the peptic ulcer cohort were treated with Hemospray combination therapy. Haemostasis rates of 92% were achieved relative to 89% in the overall peptic ulcer bleed cohort. 20/108 (19%) had a rebleed and 30-day mortality of 17% (20/119). The most common combination therapy was Hemospray with adrenaline injection therapy with a haemostasis rate of 93% (49/53). Hemospray was used as a second modality in 36/66 (55%) cases. In the remaining cases it was used as a 3rd modality, and a 4thmodality in one case. 58% of all patients had Forrest 1b ulcers where a haemostasis rate of 91% was achieved, re-bleeding in 12/69 (17%). 18% of patients had Forrest 1a ulcers with immediate haemostasis in 21/24 (88%) patients, re-bleed in 4/18 (22%) patients. In the post endoscopic therapy cohort, a 100% haemostasis rate was achieved with a 4% (1/26) re-bleed. Most of the cases were post endoscopic mucosal resection (22/37, 59%). The most common combination therapy was Hemospray and adrenaline injection (24% of patients). In malignancy related UGIB's an 86% (25/29) haemostasis rate was achieved, with a rebleed rate of 17% (4/23). The most common combination was Hemospray and adrenaline injection therapy (12/29, 41%) where a 92% haemostasis rate was achieved and one re-bleed. In variceal bleeds (5 oesophageal, 2 gastric) a haemostasis rate of 86% (6/7) was achieved, a rebleed rate of 29%. Hemospray was used as the second modality to banding/glue injection in the majority of cases.
Conclusion(s): High haemostasis rates were achieved following treatment with Hemospray in all the subgroups. In peptic ulcers high haemostasis and reasonable re-bleeding rates were achieved in Forrest 1a/1b ulcers. Results show that Hemospray combination therapy can have a role in lower GI bleeds. There is a shift towards use of Hemospray as part of standard combination therapy. Its role needs to be clearly defined within the GI bleed algorithm. Disclosure: M.H - Speaker fees (Cook Medical), R.H - Received research grant support from Pentax Medical, Cook Endoscopy, Fractyl Ltd, C2 therapeutics and Medtronic to support research infrastructure

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

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).

We describe 2 cases in which video capsule endoscopy was performed remotely using TeleInGEstion Remote Video Capsule Endoscopy (TIGER VCE), given limited access to endoscopy during the COVID-19 pandemic. The patients ingested the CapsoCam capsule during a televisit, and the video was subsequently reviewed remotely by the physician. TIGER VCE was used to diagnose a benign etiology of melena and used to confirm a diagnosis of Crohn's disease before the initiation of biologic therapy. These cases demonstrate the safety and efficacy of TIGER VCE. We feel that this technique may be considered as a standard ingestion technique in the future.

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.

Coronavirus disease 2019 (COVID-19) is associated with considerable morbidity and mortality. The number of confirmed cases of infection with SARS-CoV-2, the virus causing COVID-19 continues to escalate with over 70 million confirmed cases and over 1.6 million confirmed deaths. Severe-to-critical COVID-19 is associated with a dysregulated host immune response to the virus, which is thought to lead to pathogenic immune dysregulation and end-organ damage. Presently few effective treatment options are available to treat COVID-19. Leronlimab is a humanized IgG4, kappa monoclonal antibody that blocks C-C chemokine receptor type 5 (CCR5). It has been shown that in patients with severe COVID-19 treatment with leronlimab reduces elevated plasma IL-6 and chemokine ligand 5 (CCL5), and normalized CD4/CD8 ratios. We administered leronlimab to 4 critically ill COVID-19 patients in intensive care. All 4 of these patients improved clinically as measured by vasopressor support, and discontinuation of hemodialysis and mechanical ventilation. Following administration of leronlimab there was a statistically significant decrease in IL-6 observed in patient A (p=0.034) from day 0-7 and patient D (p=0.027) from day 0-14. This corresponds to restoration of the immune function as measured by CD4+/CD8+ T cell ratio. Although two of the patients went on to survive the other two subsequently died of surgical complications after an initial recovery from SARS-CoV-2 infection.