Faculty Bibliography

INTRODUCTION: Hospitalization for flare of inflammatory bowel disease (IBD) is associated with significant morbidity and healthcare costs. We aimed to examine the relationship between IBD severity at presentation and adverse outcomes in patients hospitalized with flare. Additionally, we aimed to create and validate a predictive model for length of stay (LOS) using markers of disease severity.
METHOD(S): We conducted a retrospective cohort study of IBD patients hospitalized with flare at two urban academic medical centers. We collected demographic and IBD-related data including the presence of Clostridioides difficile and markers of disease severity at presentation. The primary outcome was a composite of adverse inpatient IBD outcomes, including LOS >7 days, anti-TNF administration, and surgery. The data was split into training (70%) and validation (30%) samples. Employing variables of disease severity, models (including logistic regression, Classification and Regression Tree (CART), and Random Forest (RF) modeling techniques) were created to predict LOS >7 days using the training sample. These models were adjusted for surgery and anti-TNF administration, and their performance was subsequently validated.
RESULT(S): A total of 187 IBD patients hospitalized with flare were included (Table 1). The composite primary outcome was achieved in 71 patients (38%) with 51 (27%) hospitalized for >7 days. In univariate analyses, C-reactive protein and C. difficile positivity correlated with anti-TNF administration and surgery (Table 2). Adjusting for anti-TNF administration and surgery, tachycardia (OR 1.07; 95% CI 1.05-1.10), hypotension (1.07; 1.03-1.11), hypoalbuminemia (2.87; 1.81-4.74), leukocytosis (1.17; 1.09-1.27), anemia (1.10; 1.05-1.15) and C. difficile posi-tivity (2.63; 1.27-5.47) were predictive of prolonged LOS (Table 2). In multivariate analyses, tachycardia predicted the primary composite outcome of all adverse effects (OR 1.07; 95% CI 1.03-1.11). C. difficile positivity (OR 4.33; 95% CI 1.36-14.9), hypoalbuminemia (3.25; 1.29-9.01), and tachycardia (1.11; 1.06-1.16) predicted prolonged LOS (.7 days). The CART and RF models had acceptable accuracy, sensitivity, and specificity for predicting LOS >7 days (Table 3).
CONCLUSION(S): C. difficile positivity, hypoalbuminemia, and tachycardia at presentation predicted prolonged length of stay in a multicenter cohort of IBD patients hospitalized with flare. CART and Random Forest models perform well in predicting prolonged length of stay in these patients

BACKGROUND:Ileal pouch-anal anastomosis is a common surgical procedure in patients with an initial diagnosis of ulcerative colitis or indeterminate colitis. Tobacco smoking has been associated with protection from onset of ulcerative colitis. Smoking has been reported to be both a protective factor and a risk factor for the development of pouchitis. AIM/OBJECTIVE:To examine the influence of smoking on the risk of pouchitis. METHODS:We identified 15 studies evaluating smoking as a risk factor for developing pouchitis in ulcerative colitis or indeterminate colitis patients with a history of ileal pouch-anal anastomosis in a systematic search performed from inception through May 4, 2020. A meta-analysis was then performed using a random-effects model to generate risk ratios (RR) and 95% confidence intervals (CI). RESULTS: = 78.5%). CONCLUSIONS:Smoking, past or present, is not associated with an increased risk for the development of pouchitis in patients with ulcerative colitis or indeterminate colitis.

INTRODUCTION: Multi-society recommendations state, "Given the importance of polyp size for informing surveillance intervals, documentation of a polyp > 10 mm within a report should be accompanied by an endoscopic photo of the polyp with comparison to an open snare or open biopsy forceps".¹ We evaluate the feasibility of the Napoleon, an endoscopically-deployed small ruler to more accurately measure and document the size of colon polyps.
METHOD(S): The Micro-Tech Endoscopic Gauge (Non-FDA approved) named Napoleon, a catheter with a 15 mm ruler calibrated in 1 mm intervals with demarcations every 5 MM, was advanced through the biopsy channel of a colonoscope and positioned adjacent to a polyp to accurately measure polyp size (Image 1). Polyps sizes were first assessed visually and then measured using the Napoleon. Patients included were 50 to 85 years of age and undergoing screening or surveillance colonoscopy. Napoleon placement, extension/retraction, and photograph acquisition were evaluated on a 1-s10 scale (1 = Easy, 10 = Difficult).
RESULT(S): 23 patients were evaluated by 6 physicians. A total of 36 polyps were found. Each score represents the average of several polyps if more than one polyp was identified per patient (Table 1). The most polyps found in any patient was 3. Each polyp size was placed into 1 of 3 categories (Table 2): 1-5 mm (Diminutive), 6-9 mm (Small) and $ 10 mm (Large). 30 of the 36 total polyps (83%) were diminutive. 3 polyps were downgraded into the next smaller size category after measurement with the Napoleon - specifically, 1 polyp (33%) dropped from small to diminutive size and 2 polyps (67%) dropped from large to small size.
CONCLUSION(S): Prior studies on polyp size have shown that visual assessment is inaccurate.² This study demonstrates the ease and feasibility of the Napoleon as an endoscopic measuring device. The majority of polyps found were diminutive (1-5 mm) and explains why there is such a minute difference noted in the weighted mean polyp size (0.28 mm). Of the 3 polyps that were visually assessed to be $ 10 mm, 2 of those polyps (67%) were measured to be < 10 mm, changing recommended surveillance from 3 years to 7-10 years.¹ Further studies utilizing an endoscopic measuring tool such as the Napoleon are needed to evaluate the effect of accurate polyp measurement on our clinical management, training, and colonoscopy surveillance intervals

BACKGROUND/AIMS/OBJECTIVE:Room air (RA) and carbon dioxide (CO2) are widely used to insufflate the colon to examine the mucosa in colonoscopy. Pain, discomfort, and bloating can be seen during and after colonoscopy secondary to bowel distention. This study aimed to investigate the effect of CO2 on post-procedure pain sensation (PPPS) in comparison with RA. MATERIALS AND METHODS/METHODS:Patients were randomly assigned to the RA and CO2 insufflation groups in a 1:1 ratio. The visual analog scale (VAS) was used to measure the pain before and after the colonoscopy. VAS score of 0 was accepted as the absence of pain and above 0 was accepted as the presence of pain. The primary outcome was to investigate the effect of CO2 insufflation on PPPS. Secondary outcomes were to investigate the other contributing factors affecting PPPS and the effect of CO2 on PPPS in patients with inflammatory bowel disease (IBD). RESULTS:A total of 204 patients were enrolled in the study. No significant difference in PPPS was seen between the 2 groups at any point in time after the colonoscopy. Furthermore, there was no significant difference in pain sensation between the CO2 and RA groups in patients with IBD. When we investigated the other contributing factors to pain sensation, body-mass index (BMI) was found to be significant at 30 minutes and BMI and colonoscopy time were found to be significant at 6 hours afterwards. CONCLUSION/CONCLUSIONS:We found no favorable effect of CO2 insufflation on PPPS in colonoscopy, including in patients with IBD.

INTRODUCTION: Ustekinumab has been recently approved for the treatment of moderately to severely active ulcerative colitis (UC). The registry trials for ustekinumab in UC demonstrated efficacy and safety, but data on the effectiveness and safety in the real world are limited. We describe the effectiveness and safety of ustekinumab in patients with UC from two US tertiary IBD centers.
METHOD(S): Patients with moderately to severely active UC treated with ustekinumab at NYU Langone Medical Center (New York, NY) and University of Chicago Medical Center (Chicago, IL) between January 2016 and March 2020 were retrospectively included. The primary outcome was clinical remission at 3 and 12 months, defined as a partial Mayo score of 2, with a combined rectal bleeding and stool frequency subscore of #1.
RESULT(S): Sixty-six UC patients were included (Table 1). 61% of patients had extensive colitis and overall mean total Mayo score was 6.5 +/- 2.4. 92% of patients had prior exposure to biologics or tofacitinib. 43% and 45% of patients achieved clinical remission by 3 and 12 months, respectively (Figure 1). Anti-TNF non-response and endoscopic Mayo score of 3 were negative predictors of clinical remission at 3 months (Table 2). At 1 year, 50% of patients achieved endoscopic remission and 33% achieved mucosal and histo-endoscopic healing. The achievement of histo-endoscopic healing was significantly associated with lower partial Mayo score (0.5 +/- 0.6 vs. 3.5 +/- 1.7; P < 0.01) and lower stool frequency (0.3 +/- 0.5 vs. 1.4 +/- 0.7; P = 0.02). Serious adverse events occurred in 4 (6%) patients (3 UC exacerbations, 1 vasculitis).
CONCLUSION(S): In this cohort of mostly biologic-refractory UC patients, treatment with usteki-numab achieved remission in nearly half of them at 12 months, and was associated with an overall favorable safety profile. These results are modestly better than the pivotal trials

INTRODUCTION: Ileal pouch-anal anastomosis (IPAA) is a common surgical procedure in patients with an initial diagnosis of ulcerative colitis (UC), indeterminate colitis (IC), or familial adenomatous polyposis syndrome (FAP). Tobacco smoking has been associated with protection from onset of UC. Smoking has been reported to be both a protective factor and a risk factor for the development of pouchitis. In this systematic review and meta-analysis, we examine the influence of smoking on the risk of pouchitis.
METHOD(S): We identified 16 studies evaluating smoking as a risk factor for developing pouchitis in patients with a history of IPAA in a systematic search performed from inception through May 2020. A meta-analysis was then performed using a random-effects model to generate risk ratios.
RESULT(S): A total of 2,389 IPAA patients were included in the systematic review and meta-analysis. In the included studies, the percentage of patients with a diagnosis of pouchitis ranged from 22% to 72%. The percentage of patients with a history of smoking ranged from 7% to 63%. In total, 919 patients had pouchitis (330 current or former smokers; 589 non-smokers), and 1,470 patients did not have pouchitis (485 current or former smokers; 985 non-smokers). A history of smoking compared with never smoking was not associated with an increased risk of developing pouchitis (RR = 0.96, 95% CI 0.78-1.17, I² 5 68.6%). There was also no significant risk of pouchitis when comparing current smokers versus non-smokers (RR = 1.09, 95% CI 0.93-1.28, I² 5 0%) and former smokers versus non-smokers (RR = 0.95, 95% CI 0.70-1.28, I² 5 79.8%).
CONCLUSION(S): Smoking, past or present, is not associated with an increased risk for the development of pouchitis. This is important to consider when counseling patients on the risks of smoking and pouchitis

INTRODUCTION: Guidelines recommend testing inflammatory bowel disease (IBD) patients hospitalized with flare for Clostridioides difficile infection (CDI), though little is known about whether a delay in testing for CDI is related to adverse outcomes. We examined the relationship between time to C. difficile PCR test order, collection, and result with adverse IBD outcomes.
METHOD(S): We performed a retrospective cohort study of IBD patients hospitalized with flare through the emergency department (ED) between 2013 and January 2020 at an urban academic medical center. The time from ED presentation to CDI test order (time-to-order), sample collection (time-to-collection), and test result (time-to-result) were collected. Time-to-result was stratified by within+/-hours, 6-24 hours, and 24 hours or longer. The primary outcome was length of stay (LOS). Secondary outcomes were inpatient anti-TNF administration and surgery. Separately, we used initial hemodynamic and laboratory values to create an IBD hospitalization severity score for evaluation against LOS and time-dependent variables.
RESULT(S): We identified 122 IBD patients hospitalized with flare. There were no significant differences in baseline characteristics among time-to-result groups. There was no difference in time-toorder between the+/-hours and 6-24 hours groups (Table 1). Despite a shorter time-to-result, the average LOS in the+/-hours group was 7.3 days, longer compared to the 6-24 hours group (4.3 days, P=0.018) and the 24 hours group (4.2 days, P=0.035Table 1). There were no differences in inpatient anti-TNF administration (P=0.10) or surgery (P=0.08) among time-to-result groups. Markers of disease severity correlated with longer LOS and earlier time-to-result (Table 2). A composite of these markers was used to stratify patients by disease severity. Those with more severe disease had earlier times-to-result (12.8 hours vs. 32.2 hours, P=0.014) and had a longer LOS (7.9 vs. 3.4 days, P=0.007) with no difference in time-to-order compared to patients with less severe disease (P=0.09Table 3).
CONCLUSION(S): Earlier time-to-result for CDI is associated with longer LOS in IBD patients hospitalized with flare. This inverse relationship is confounded by disease severity at presentation. Patients with more severe disease have a shorter time-to-result and a longer LOS without any difference in time-to-order. Delay in testing was not associated with higher rates of inpatient anti- TNF administration or surgery

INTRODUCTION: Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of UC. Changes in liver enzymes, lipids, hemoglobin (Hb), absolute neutrophil count (ANC), and absolute lymphocyte count (ALC) have been observed during 8-wk induction and 52-wk maintenance therapy with tofacitinib in patients (pts) with UC [1]. Monitoring of select parameters is recommended in pts treated with tofacitinib per product labeling [2].
METHOD(S): Changes from baseline in liver enzymes, lipids, ANC, ALC, and Hb were investigated in pts with UC treated with tofacitinib in an ongoing Phase 3, open-label, long-term extension (OLE) study (NCT01470612; data as of May 2019, database not locked). Pts who completed or demonstrated treatment failure in OCTAVE Sustain, or were non-responders after completing OCTAVE Induction 1 or 2, were eligible for the OLE study. Pts in remission at the end of OCTAVE Sustain received tofacitinib 5 mg twice daily (BID); all other pts received tofacitinib 10 mg BID in the OLE study. Proportions of pts with laboratory values meeting protocol discontinuation criteria (Table), proportions of pts with investigator-defined treatment-emergent adverse events (TEAEs) of hyper-lipidemia, and proportions of pts with an addition of or change in lipid-lowering agent (LLA), were also evaluated.
RESULT(S): Changes from OLE study baseline in liver enzymes, lipids, ANC, ALC, and Hb at Months 36 and 48, and the proportion of pts meeting protocol discontinuation criteria, are presented (Table). Findings were generally similar to the previously presented Sep 2018 data cut, which focused on Month 36 [3]. Hyperlipidemia TEAEs occurred in 2.3% and 1.3% of pts treated with tofacitinib 5 and 10 mg BID, respectively. Furthermore, 9.7% and 6.8% of pts treated with tofacitinib 5 and 10 mg BID, respectively, had a new LLA added, and 2.9% and 1.8% of pts treated with tofacitinib 5 and 10 mg BID, respectively, had their LLA dose increased.
CONCLUSION(S): No major changes from OLE study baseline were observed with tofacitinib in laboratory parameters recommended for monitoring up to Month 48. Proportions of pts meeting protocol discontinuation criteria for liver enzymes, ANC, ALC, or Hb, with hyperlipidemia TEAEs, or with a change in LLA, were low. Due to OLE study dose assignment, pt baseline remission status differs across treatment arms

INTRODUCTION: Colorectal cancer (CRC) is the third common cause of cancer death in the US. The incidence of CRC is higher in minority racial and ethnic groups. Traditionally, CRC has had a higher mortality rate in men when compared to women. However, studies assessing trends among sex and racial groups on the incidence and mortality of CRC is lacking. We aim to investigate disparities in CRC by reviewing a large national cancer registry.
METHOD(S): This is a retrospective cross-sectional study of the Surveillance, Epidemiology and End Results Registry (SEER) of individuals aged 45-79 years from 2000 to 2017. Race was classified as White, Black, American Indian/Alaska Native, and Asian or Pacific Islander. Annual percent change (APC) and incidence risk ratios (IRR) were calculated for sex and race. Kaplan-Meier estimations and log-rank tests were used to evaluate cancer-specific survival outcomes. Statistical significance was set at P < 0.05.
RESULT(S): Among 690,450 patients, there were 512,285 patients age 45-79 years diagnosed with CRC from 2000 to 2017. A higher proportion of patients had distal tumors versus proximal tumors (62% vs 38%, P < 0.001). SEER summary staging showed that most tumors were localized (40%) compared to regional (35%), distant cancer (20%), and unknown (4%). Approximately 23% of tumors on presentation occurred in the rectum (n = 114,873), followed by 21% in the sigmoid (102,850), 14% in the cecum (70,084), 12% in the ascending colon (n = 60,227), and 29.5% other locations. During the study period, the incidence of CRC decreased for both males and females, respectively (APC 22.14 vs 21.81). Amongst all racial groups, African American showed the least decline in incidence of CRC. African American females showed the highest risk for CRC (IRR 1.34; 95% CI 1.32-1.36, P < 0.001) compared to other females or males from different racial groups [Figure 1]. Subgroup analysis using Kaplan Meier estimations showed that African American females had the poorest 5-year survival rate (56%) compared to White females (66%), American Indian/Alaska Native females (58%), and Asian or Pacific Islander females (66%). Among males, American Indian/Alaska Natives had the poorest 5-year survival (54%) compared to African American males (61%), White males (66%), and Asian or Pacific Islander males (66%).
CONCLUSION(S): Overall, the incidence of colorectal cancer is declining. However, the incidence of CRC remains highest in African Americans females who are also burden with poor survival rates

PURPOSE/OBJECTIVE:For more than half of Crohn's disease patients, strictures will cause bowel obstructions that require surgery within 10 years of their initial diagnosis. This study utilizes computed tomography imaging and clinical data obtained at the initial emergency room visit to create a prediction model for progression to surgery in Crohn's disease patients with acute small bowel obstructions. METHODS:A retrospective chart review was performed for patients who presented to the emergency room with an ICD-10 diagnosis for Crohn's disease and visit diagnosis of small bowel obstruction. Two expert abdominal radiologists evaluated the CT scans for bowel wall thickness, maximal and minimal luminal diameters, length of diseased segment, passage of oral contrast, evidence of penetrating disease, bowel wall hyperenhancement or stratification, presence of a comb sign, fat hypertrophy, and small bowel feces sign. The primary outcome was progression to surgery within 6 months of presentation. The secondary outcome was time to readmission. RESULTS:Forty patients met the inclusion criteria, with 78% receiving medical treatment alone and 22% undergoing surgery within 6 months of presentation to the emergency room. Multivariable analysis produced a model with an AUC of 92% (95% CI 0.82-1.00), 78% sensitivity, and 97% specificity, using gender, body mass index, and the radiographic features of segment length, penetrating disease, and bowel wall hyperenhancement. CONCLUSIONS:The model demonstrates that routine clinical and radiographic data from an emergency room visit can predict progression to surgery, and has the potential to risk stratify patients, guide management in the acute setting, and predict readmission.