Faculty Bibliography

BACKGROUND:Intragastric balloons are anatomy-preserving, minimally invasive obesity therapies. Enhanced tolerance and durability could help broaden clinical adoption. We investigated the safety and efficacy of an adjustable intragastric balloon (aIGB) in adults with obesity. METHODS:In this prospective, multicentre, open-label, randomised clinical trial done at seven US sites, adults aged 22-65 years with obesity were randomly assigned (2:1) to aIGB with lifestyle intervention or lifestyle intervention alone (control) for 32 weeks. Balloon volume could be increased to facilitate weight loss or decreased for tolerability. Coprimary endpoints included mean percentage total bodyweight loss and responder rate (≥5% total bodyweight loss) at 32 weeks. We used a multiple imputed intention-to-treat population analysis. This study was registered with ClinicalTrials.gov, NCT02812160. FINDINGS/RESULTS:Between Aug 9, 2016, and Dec 7, 2018, we randomly assigned 288 patients to aIGB (n=187 [65%]) or control (n=101 [35%]) groups. Mean total bodyweight loss at 32 weeks was 15·0% (95% CI 13·9-16·1) in the aIGB group versus 3·3% (2·0-4·6) in the control group (p<0·0001). Clinical response was observed in 171 (92%) patients in the aIGB group. Adjustments to the aIGB occurred in 145 (80%) patients for weight loss plateau or intolerance. Upward volume adjustment facilitated an additional mean 5·2% total bodyweight loss. Downward volume adjustment allowed 21 (75%) patients in the aIGB group to complete the full duration of therapy. Intolerance caused early removal of the device in 31 (17%) patients. No micronutrient deficiencies were observed in the aIGB cohort. Device-related serious adverse events were observed in seven (4%) patients, without any deaths. INTERPRETATION/CONCLUSIONS:When aIGB was combined with lifestyle modification, significant weight loss was achieved and maintained for 6 months following removal. Balloon volume adjustability permitted individualised therapy, maximising weight loss and tolerance. FUNDING/BACKGROUND:Spatz Medical.

Introduction: Digestive laboratory abnormalities related to COVID-19 have been previously described, but most reports came from single centers and findings have been conflicting. We conducted a multi-center study using data from three large urban VA centers (New York Harbor VA, New Orleans VA and Detroit VA) to examine the association between demographics and digestive laboratory values with mortality on index hospitalization among individuals diagnosed with COVID-19.
Method(s): We manually extracted data on individuals hospitalized for COVID-19 between December 2019 and June 2020 at the three facilities. For this analysis, data on demographics and seven digestive laboratory values (highest AST, ALT, alkaline phosphatase, total bilirubin, and INR during admission, as well as lowest hemoglobin and platelets) were analyzed in relation to index hospitalization mortality. We performed descriptive statistics and conducted a multivariable logistic regression model.
Result(s): Out of a total of 390 individuals who were hospitalized with COVID-19, 168 (43%) died and 222 survived. The median age of patients who died was higher than those who survived (75 vs. 69 years). The vast majority (94%) of patients were male. Black patients accounted for a higher proportion of those who died than those who survived (61% vs. 55%), whereas the opposite was true for Whites (26% vs. 31%) and Hispanics (9% vs. 12%). In the multivariable model (Table), mortality was associated with older age (OR 1.07, 95% CI 1.03-1.10), higher BMI (OR 1.05, 95% CI 1.01-1.10), higher AST (OR 1.01, 95% CI 1.004-1.02), lower ALT (OR 0.99, 95% CI 0.98-0.996), higher alkaline phosphatase (OR 1.02, 95% CI 1.01-1.02), and lower hemoglobin (OR 0.83, 95% CI 0.72-0.97).
Conclusion(s): In this multicenter VA study of patients hospitalized with COVID-19 during the first half of 2020, overall mortality was 43%. For mortality during index hospitalization, we observed a positive association with age, BMI, AST, and alkaline phosphatase, and an inverse association with ALT and hemoglobin. Every 1 unit increase in hemoglobin was associated with 17% decreased odds of death. These findings suggest that commonly used digestive laboratory tests have prognostic significance for COVID-related survival

Introduction: Non-alcoholic fatty liver disease (NAFLD) is present in 36-70% of women with polycystic ovary syndrome (PCOS). Both are highly prevalent in subjects with obesity. Androgen overproduction in PCOS promotes a pro-apoptotic environment and may contribute to NAFLD. Our objective was to examine the association between PCOS and NAFLD diagnosis and if PCOS is an independent predictor of advanced fibrosis in patients with NAFLD.
Method(s): In a single-center retrospective analysis of electronic medical records, 625 adult patients ( .18 years old) with a diagnosis of NAFLD from 2018-2019 were divided into 3 cohorts: a female study group with PCOS, female control group without PCOS, and a male control cohort, age-matched to the study group. PCOS diagnosis was based on established PCOS society criteria. Our primary outcome was to assess the stage of liver fibrosis, as defined by histology, Fibroscan, MR elastography, NAFLD fibrosis score (NFS), by the age of initial diagnosis. Additionally, demographic, laboratory and clinical parameters were analyzed to compare the three cohorts. Demographics were analyzed using ANOVA, Pearson's chi-squared, and Kruskal-Wallis methods. Linear regression modeling NAFLD score as a function of age of diagnosis was performed.
Result(s): A total of 625 subjects with NAFLD were seen. Of these, 21 met criteria for the female NAFLD/PCOS study group, 525 in the female NAFLD only control group, and 79 age-matched male subjects with NAFLD. The NAFLD/PCOS females study group were significantly younger than the other two cohorts at time of diagnosis of NAFLD, had the highest BMI of 38.4, highest AST/ALT ratio of 0.92, lowest albumin value of 4.03, highest percentage of patients with physical signs of the male cohort was associated with a 0.7 reduction in NFS compared to women with NAFLD only. Females with NAFLD demonstrate significant difference in the mean NFS and mean age of diagnosis compared to the other 2 groups, while females with both versus males with NAFLD did not (Image 1).
Conclusion(s): Females with PCOS significantly demonstrated NAFLD at an earlier age supported by positive physical and radiological signs, and worse NFS vs. males at the time of initial NAFLD diagnosis.

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.

GOALS AND BACKGROUND/OBJECTIVE:Ustekinumab (UST) is a monoclonal antibody inhibitor of IL-12/IL-23 approved for the treatment of Crohn's disease (CD) and ulcerative colitis (UC). We conducted a meta-analysis to compare rates of adverse events (AEs) in randomized controlled trials (RCTs) of UST for all indications. STUDY/METHODS:A systematic search was performed of MEDLINE, Embase, and PubMed databases through November 2019. Study inclusion included RCTs comparing UST to placebo or other biologics in patients aged 18 years or older with a diagnosis of an autoimmune condition. RESULTS:Thirty RCTs with 16,068 patients were included in our analysis. Nine thousand six hundred and twenty-six subjects were included in the UST vs placebo analysis. There was no significant difference in serious or mild/moderate AEs between UST and placebo with an OR of 0.83 (95% CI 0.66, 1.05) and 1.08 (95% CI 0.99, 1.18), respectively, over a median follow-up time of 16 weeks. In a sub-analysis of CD and UC trials, no difference in serious or mild/moderate AEs in UST versus placebo was seen. CONCLUSIONS:UST was not associated with an increase in short-term risk of AEs.

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.

Background and study aims  Women remain underrepresented in gastroenterology, especially advanced endoscopy. Women represent 30 % of general gastroenterology fellows; yet in 2019, only 12.8 % of fellows who matched into advanced endoscopy fellowship (AEF) programs were women. Methods  We administered a web-based survey to the program directors (PDs) of AEF programs that participated in the 2018-2019 American Society for Gastroenterology (ASGE) match. We assessed PD and program characteristics, in addition to perceived barriers and facilitators (scale 1-5, 5 = most important) influencing women pursuing AEF training. Results  We received 38 (59.3 %) responses from 64 PDs. 15.8 % (6/38) of AEF PDs and 13.2 % (5/38) of endoscopy chiefs were women. By program, women represented 14.8 % (mean) ± 17.0 % (SD) of AEF faculty and 12.0 % (mean) ± 11.1 % (SD) of AEF trainees over the past 10 years. 47.4 % (18/38) programs reported no female advanced endoscopy faculty and 31.6 % (12/38) of programs have never had a female fellow. Percentage of female fellows was strongly associated with percentage of female AEF faculty (ß = 0.43, P  < 0.001). Inflexible hours and call (mean rank 3.3 ± 1.1), exposure to fluoroscopy (2.9 ± 1.1), lack of women endoscopists at national conferences/courses (2.9 ± 1.1) and lack of female mentorship (2.9 ± 1.0) were cited as the most important barriers to recruitment. Conclusion  We utilized a survey of AEF PDs participating in the ASGE match to determine program characteristics and identify contributors to gender disparity. Women represent a minority of AEF PDs, endoscopy chiefs, advanced endoscopy faculty and AEF trainees. Our study highlights perceived barriers and facilitators to recruitment, and emphasizes the importance of having female representation in faculty, and leadership positions in endoscopy.

BACKGROUND & AIMS/OBJECTIVE:Our study aims to clarify the relationship between weight parameters and colorectal cancer outcomes. METHODS:statistic. RESULTS:Our meta-analysis included 45 studies encompassing 607,266 patients. Obesity was associated with increased odds of overall mortality and CRC-specific mortality compared to normal weight (p < 0.001). Patients with underweight BMI had increased odds of CRC-specific mortality compared to normal BMI but were not significantly different from obese BMI. CONCLUSIONS:Obese and underweight BMI are associated with increased CRC-specific and overall mortality compared to normal BMI. Long term prognosis was similar for patients with obese and underweight BMI.

BACKGROUND:Polycystic ovarian syndrome (PCOS) is a leading cause of infertility among women of reproductive age. The interplay between hyperinsulinemia and obesity results in many of the reproductive and hormonal changes seen in PCOS including abnormal menses, infertility, and pregnancy loss. While bariatric surgery has been found to be an effective treatment strategy for morbid obesity, its role in the management of PCOS-related infertility compared to standard therapy (metformin) is less clear. AIMS/OBJECTIVE:To assess the impact of bariatric surgery on pregnancy outcomes in women with PCOS compared to metformin therapy in a systematic review and meta-analysis. METHODS:MEDLINE, EMBASE, PubMed, and Google Scholar were searched from inception to August 2019. Studies that reported quantitative data on pregnancy outcomes on women of reproductive age with PCOS with at least a 3-month follow-up and a minimum of 5 or more sample size were included. The primary outcome was pregnancy rate, expressed as an event rate and 95% confidence interval (95% CI). RESULTS:Ten studies with a total of 587 patients were included in the final analyses (Metformin: 5 studies, n = 192; Bariatric surgery (BS): 5 studies (2 Roux-en-Y gastric bypass, 2 sleeve gastrectomy, 1 Roux-en-Y gastric bypass + sleeve gastrectomy), n = 186). The average time to follow-up was 18.25 months (range 3-36) with a shorter time to follow-up in the metformin group compared to the bariatric surgery group (Metformin: 11.2 vs BS: 24.5 months). While metformin increased the likelihood of pregnancy compared to placebo or non-surgical interventions (OR = 3.08, 95% CI 1.29-7.37, p = 0.01), the pregnancy rate after bariatric surgery was greater than metformin (34.9%, 95% CI 0.20-0.53 vs 17.1%, 95% CI 0.12-0.23, p = 0.026 for the difference). Additionally, there was a trend to a greater improvement in menstrual irregularity in the bariatric group compared to the metformin group with a reduction of 92% in the bariatric cohort compared to a reduction of 54% in the metformin cohort, but the data was limited. CONCLUSION/CONCLUSIONS:Bariatric surgery appears to be a more effective treatment strategy for patients with PCOS and class 3 obesity compared to metformin alone. Women with PCOS and infertility should consider bariatric surgery for weight loss and improvement in pregnancy outcomes.