bluuebunny/crossref_metadata_2025 huggingface dataset:
680 Intestinal Resection and Clostridioides difficile Infection in Inflammatory Bowel Disease Patients: A Single Center Retrospective Cohort Study
Authors: Baray Merwise , Dickson Zachary , Hunold Thomas , Behm Brian , Hays R. Ann
Published: October 2019

INTRODUCTION:

In inflammatory bowel disease patients (IBD), Crohn's disease carries a greater risk for surgical resection than ulcerative colitis (UC) through 10 years after diagnosis. Prior studies identify small bowel resection and colectomy as risk factors for the development of Clostridioides difficile infection (CDI). This study assessed the correlation between acquisition of CDI and timing of intestinal resection in IBD patients.

METHODS:

A retrospective cohort of patients age 18-75 with a history of IBD and a diagnosis of CDI from Jan 2012–Dec 31, 2016. Patient demographics, history of intestinal resection, and history of a single CDI or multiple CDI were reviewed. CDI index case was chosen as the infection with the closest timing to intestinal resection. Statistical analysis was performed with Chi-square testing.

RESULTS:

121 IBD patients with CDI were identified. 48 patients (39.7%) underwent surgical resection (25 UC and 23 Crohn's). Of these, 16 patients had a single episode of CDI and 32 patients had a history of multiple CDI. CDI occurred prior to intestinal resection in 84% of UC patients and only 47.8% of Crohn's patients (P = 0.008). This relationship was mirrored in those with history of multiple CDIs (P = 0.006), but not for patients with history of a single CDI (P = 0.38). Within 1 month of surgical resection, there was no difference in the development of CDI for Crohn's compared to UC patients. However, in Crohn's patients with a history of multiple CDI, 77.8% experienced a CDI after a partial or total colectomy.

CONCLUSION:

In this cohort of IBD patients, CDI prior to surgery is more common in UC patients as compared to Crohn's. This likely reflects CDI's predilection for the colonic mucosa, which is altered by the pro-inflammatory state of UC. A history of CDI is not as common in Crohn's patients undergoing surgery likely due to decreased colonic involvement. Further investigation into CDI in Crohn's patients after colonic resection is warranted. This information may be used to guide therapeutic discussions with IBD patients who are diagnosed with CDI.
690 Ustekinumab Maintained Clinically Meaningful Improvement in Health-Related Quality of Life in Patients With Moderate to Severe Crohn's Disease: Results From the IM-UNITI Long-Term Extension
Authors: Sands Bruce E. , Han Chenglong , Gasink Christopher , Bin Zou , Stephen Targan , Sandborn William J. , Feagan Brian G.
Published: October 2019

INTRODUCTION:

The IM-UNITI study evaluated the safety and efficacy of subcutaneous (SC) ustekinumab (UST) maintenance therapy in patients with moderately to severely active Crohn's disease (CD) who completed induction treatment with UST. Previously, we reported the effects of UST on health-related quality of life (HRQoL) through Wk44. Here, we evaluated HRQoL through Wk140 in patients who entered the long-term extension of the IM-UNITI study.

METHODS:

Patients who completed the safety and efficacy evaluation at Wk 44 of the maintenance study were eligible to continue their regimen in the extension study (placebo [PBO], UST 90 mg q12w, or UST 90 mg q8w). All patients who were treated in the extension study were included in this analysis of Inflammatory Bowel Disease Questionnaire (IBDQ) and SF-36 data according to the treatment they received during the extension study. The IBDQ is a 32-item questionnaire with 4 dimensions: bowel symptoms, systemic symptoms, emotional function, and social function. The total score ranges from 32 to 224, higher scores indicate better quality of life, and a change ≥16 points was defined as clinically meaningful. For SF-36, a change ≥5 points was defined as clinically meaningful.

RESULTS:

For patients who entered the extension, mean total IBDQ scores and SF-36 scores at maintenance baseline were comparable across treatment groups (Table 1). Patients who received UST maintained the improvement in IBDQ and SF-36 that was achieved by maintenance baseline through Wk140, and those who received PBO generally worsened. Through Wk 140, 26.5% of patients receiving PBO, 61.5% of patients receiving UST 90 mg q12w, and 59.3% of patients receiving UST 90 mg q8w had ≥16-point improvements from induction baseline in IBDQ score. In addition, 10.9%, 51.6%, and 54.2%, respectively, had ≥5-point improvements in SF-36 physical component summary scores, and 8.7%, 43.8%, and 43.7%, respectively, had ≥5-point improvements in SF-36 mental component summary scores during the same period.

CONCLUSION:

In patients who entered the long-term extension of the IM-UNITI study, those who received SC UST maintenance generally maintained improvements in IBDQ and SF-36 scores that were achieved through IV induction, and those who received PBO gradually lost these improvements.
722 Racial Differences in the Experience of Inflammatory Bowel Disease
Authors: McGrath Brian , Zheng Ziduo , Huang Eugene , Iskandar Heba
Published: October 2019

INTRODUCTION:

In patients with inflammatory bowel disease (IBD), disease-related worries and concerns can have a substantial impact on clinical outcomes. However, most of the existing literature addressing IBD, its treatment, and disease-related concerns is drawn from majority Caucasian populations. This study aims to compare IBD-related worries and concerns among African American (AA) and non-African American (non-AA) patients.

METHODS:

We performed a cross-sectional study of IBD patients receiving biologic infusion therapy at a large academic medical center using the Rating Form of IBD Patient Concerns (RFIPC, © 1991, Rome Foundation Inc). This validated tool contains 25 items that assess concerns falling within four sub-domains on a scale from 1-100: impact of disease (IOD), sexual intimacy (SI), complications of disease (CD), and body stigma (BS). Total score, sub-domain scores, and individual item scores were compared between AA and non-AA groups using linear regression analysis, adjusting for age and sex. RFIPC used with permission of Mapi Research Trust, Lyon, France: https://eprovide.mapi-trust.org.

RESULTS:

Of 53 patients included in this preliminary analysis, 17 were AA and 36 were non-AA. AA participants tended to be younger (35.8 vs 45.3) and more predominantly female (71% vs 42%) compared to non-AA participants. Although AA participants tended to report a greater total burden of concerns, the difference was not significant (mean difference 91.75, P 0.65). AA patients had significantly greater concern in BS (mean difference 28.09, P 0.02); while there was a trend toward higher scores in other sub-domains in the AA group, these were not significant. Type 3 fixed effects analysis revealed significant effect of age on sum score (P 0.01) and IOD (P 0.01) and of sex on SI (P 0.05) and BS (P 0.01).

CONCLUSION:

Our results suggest that AA patients may experience slightly more IBD-related concern than non-AA patients. Although only the difference in concerns related to body stigma was significant, there was a trend toward greater concern in all other subdomains as well as overall concern in the AA group. We predict more significant differences with continued patient enrollment. Our study highlights important issues to discuss with AA patients, particularly relating to hygiene and self-awareness. As the prevalence of IBD in African Americans continues to increase, further research in this area will facilitate delivery of optimal IBD care for this population.
743 The Socioeconomic Impact of Living With Ulcerative Colitis: A Burden of Illness Study
Authors: Limdi Jimmy K. , Rose Alison , Noone Declan , Avedano Luisa , Hayee Bu , Sturm Andreas , Peyrin-Biroulet Laurent , Finnegan Alan , Tucknott Seb , Burisch Johan , Lobo Alan J. , Terry Helen , Fiorino Gionata , Evans Jonathan
Published: October 2019

INTRODUCTION:

The living with Ulcerative Colitis (UC), identifying the socioeconomic burden in Europe (LUCID) study was a descriptive, retrospective, cross-sectional, European, multi-site, bottom-up Burden of Illness research study carried out by HCD Economics and the University of Chester in partnership with Crohn's and Colitis UK.

METHODS:

The primary objective of the LUCID study was to quantify the existing UC-related costs for each country and by disease severity. The study population was recruited through gastroenterologists (surveyed between Aug 2018-Feb 2019) and included adult patients diagnosed with UC by endoscopy and histology, at least 24 months prior the index date (date of clinical consultation). The study cohort population consisted of two arms; Arm 1: Patients with moderate or severe UC status at initiation of documentation period (12 months prior the index date) and, Arm 2: Patients with moderate or severe UC that achieved mild UC or remission at initiation of documentation period. Physician completed questionnaires (CRF) captured clinical information, direct medical costs and some direct non-medical costs. Patients completed a corresponding public patient involvement and engagement (PPIE) form which captured further direct non-medical costs and indirect costs. The economic burden per-patient was calculated by multiplying the quantities of the resource use collected with the national unit price. Total costs could only be calculated for patients with completed PPIE forms.

RESULTS:

Completed physician-reported forms (CRF) and PPIE forms were assessed for 1,658 patients. Of these, 1001 (60.7%) and 648 (29.3%) patients were in arm 1 and arm 2 respectively, with 9 patients unable to be assigned to either arm. Total average EU cost per patient in the last 12 months was €8,833.94 in arm 1 and €6,512.74 in patients in arm 2 with direct medical costs per patient amounting to €4381.70 in arm 1 and €3078.48 in arm 2. Direct non-medical costs per patient were €1353.93 for arm 1 and €1128.37 for arm 2. Societal costs per patient amounted to €3098.31 of the total cost for arm 1 and €2305.89 for arm 2.

CONCLUSION:

These preliminary results suggest that non-medical costs and indirect costs make up substantial proportions of the overall cost implying that the cost of treatment constitutes only a part of the overall burden of UC. Further analysis is planned to identify the drivers of costs in each arm in order to make comparisons between them.
746 Adalimumab Concentrations Following Dose Escalation in Inflammatory Bowel Disease
Authors: Jasurda Jake , McCabe Robert , Vaughn Byron
Published: October 2019

INTRODUCTION:

Therapeutic drug monitoring is frequently performed for the management of inflammatory bowel disease (IBD). Adalimumab (ADA) concentrations of 12-16 ug/ml have been associated with clinical and endoscopic remission in Crohn's disease (CD) and ulcerative colitis (UC). The feasibility of achieving these concentrations following a dose escalation is unknown. We aim to determine expected rise in serum ADA concentrations in response to increased dose frequency.

METHODS:

Patients with an established diagnosis of IBD, on maintenance ADA therapy, and two ADA trough concentrations were included. The primary outcome was change in ADA concentration following dose escalation from every other week to weekly. Patients who had two concentrations without a dose escalation served as a control. Student's t-test was used to assess for significant differences in and between patients. Exploratory logistic regression was used to assess for clinical factors predicting the ability to achieve an ADA concentration >12 ug/ml.

RESULTS:

Eighty-nine patients met inclusion criteria, 71% with CD, 23% with UC, and 6% with indeterminate colitis. Thirty six percent were on concurrent immunomodulator (IMM) therapy. Among patients on every other week ADA dosing, the initial mean ADA concentration for those who went on to a dose escalation was 3.7 ug/ml versus 9.7 ug/ml in those who did not dose escalate (P < 0.001). Following dose escalation, mean ADA concentration significantly increased by 5.7 ug/mL (P < 0.0001) compared to a significant decrease of 2.5 ug/mL (P < 0.002) in those who remained on every other week dosing. This decrease was driven by IMM de-escalation (mean decrease of 1.7 ug/ml in those without IMM change, versus 5.5 ug/ml in those who stopped IMM, P < 0.1). Exploratory logistic regression analysis identified initial ADA concentration, female sex, and ADA as first biologic as predictors of achieving an ADA concentration >12 ug/ml after dose escalation.

CONCLUSION:

Among patients with an initial low ADA concentration, a dose escalation to weekly will increase the concentration by 5.7 ug/ml on average. Without dose escalation, cessation of IMM may decrease ADA concentrations by 5.5 ug/ml. Female sex, ADA as first biologic, and initial ADA concentration of ≥4.9 ug/ml all predicted the ability to achieve a concentration of >12 ug/ml following dose escalation. The expected concentration change after ADA dose escalation can help to guide treating physicians in determining when dose escalation is appropriate.
824 Biologic Use in Pediatric Patients Newly Diagnosed With Ulcerative Colitis in the United States, 2010-2013 and 2014-2016
Authors: D'Haens Geert R. , Naegeli April , Mahoui Malika , Morton Stuart , Dong Yan , Hunter Theresa
Published: October 2019

INTRODUCTION:

The purpose of this study is to characterize treatment patterns and sequences of biologic initiation in pediatric patients newly diagnosed with Ulcerative Colitis (UC) in the United States in 2010-2013 and 2014-2016.

METHODS:

Pediatric (0-17 years) patients with ≥2 UC diagnosis codes (ICD-9: 556.x; ICD-10:K51.x) from October 1, 2010 to September 30, 2016 were included in this retrospective analysis of medical and pharmacy claims data from the IBM Marketscan Commercial and Medicaid Claims database. Patients were excluded if they were >18 years old, had a Crohn’s disease (CD) diagnosis, had a dual UC and CD diagnosis, or did not have treatment throughout the study period. Pathway visualization techniques and subgroups analyses were conducted for the 2 years post diagnosis to compare biologic use following first diagnosis during 2010-2013 and 2014-2016. Two-sample t test were conducted for continuous patient characteristics between 2010 -2013 and 2014-2016 diagnosis periods. Chi-square tests were used for the categorical variables.

RESULTS:

A cohort of 441 UC patients were identified with 223 (50.6%) diagnosed with UC during 2010-13 and 218 (49.4%) diagnosed during 2014-16. The proportion of male patients increased from 48.9% in 2010-2013 to 56.0% in 2014-2016. Mean age at diagnosis was not statistically different during 2010-2013 and 2014-2016 (13.5 vs. 13.5 years; P = 0.92). The majority of patients initiated conventional treatment (aminosalicylates, immunomodulators, and/or corticosteroids) at the time of diagnosis. Biologic use significantly increased from 16.1% of patients in 2010-2013 to 25.7% of patients in 2014-2016. The median time to biologic treatment in the 2 years post diagnosis was 302.5 days for those diagnosed 2010-13 versus 247.5 days for those diagnosed during 2014-16 (P = 0.1). On average, patients initiated biologic treatment 54.5 days earlier when receiving a UC diagnosis during 2014-16. Infliximab was more frequently identified as the first-line biologic in the 2 years post diagnosis for those diagnosed 2010-13 and 2014-16. However, pathway visualization Sankey diagrams illustrated limited switching from one biologic to another after initiation of biologic therapy during the 2 years post diagnosis for 2010-13 (Figure 1), with no predominant sequence identified. This trend remained for the 2014-16 cohort (Figure 2).

CONCLUSION:

Biologic use among pediatric UC patients has increased in recent years; however conventional treatment is still more common at the time of diagnosis.
836 Tofacitinib Efficacy in Patients With Moderate to Severe Ulcerative Colitis: Subgroup Analyses of OCTAVE Induction 1 & 2 and OCTAVE Sustain by 5-Aminosalicylates Use
Authors: Hanauer Stephen B. , Rubin David T. , Gionchetti Paolo , Su Chinyu , Woodworth Deborah A. , Quirk Daniel , Salese Leonardo , Wang Wenjin , Marren Amy , Lawendy Nervin , Panaccione Remo
Published: October 2019

INTRODUCTION:

Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). The efficacy and safety of tofacitinib were demonstrated in 3 Phase 3 trials (OCTAVE Induction 1 & 2, NCT01465763 & NCT01458951; OCTAVE Sustain, NCT01458574) in patients (pts) with moderate to severe UC (1). In this post-hoc analysis, we explored tofacitinib efficacy for pts with (c5-ASA) and without (n5-ASA) concomitant 5-aminosalicylates use.

METHODS:

In OCTAVE Induction 1 & 2, pts received placebo (PBO) or tofacitinib 10 mg twice daily (BID) for 8 weeks; clinical responders were re-randomized into OCTAVE Sustain for 52 weeks and received PBO, tofacitinib 5 or 10 mg BID. c5-ASA were permitted at entry, provided doses were stable for ≥4 weeks prior to and during the trials. Remission and mucosal healing were summarized at Week 8 (OCTAVE Induction 1 & 2) and Week 52 (OCTAVE Sustain) by c5-ASA status. Generalized linear models were used to compare adjusted treatment effects between 5-ASA subgroups (Tables 1 and 2).

RESULTS:

A smaller proportion of c5-ASA pts had prior tumor necrosis factor inhibitor (TNFi) and immunosuppressant failure versus n5-ASA pts, at baseline of OCTAVE Induction and OCTAVE Sustain (OCTAVE Induction 1 & 2: TNFi failure, 42.7% vs 74.5%; immunosuppressant failure, 69.4% vs 78.3%; OCTAVE Sustain: TNFi failure, 36% vs 70%; immunosuppressant failure, 67.9% vs 80%). For both the 5-ASA subgroups, a higher proportion of tofacitinib-treated pts achieved efficacy endpoints, versus PBO-treated pts, at Week 8 of OCTAVE Induction 1 & 2 and Week 52 of OCTAVE Sustain (Tables 1 and 2). Without controlling for baseline variables, higher treatment effects were observed within the c5-ASA subgroup versus the n5-ASA subgroup. When controlled for prior TNFi and immunosuppressant failure (and baseline remission status in OCTAVE Sustain), the differences were not statistically significant in treatment effects between the 5-ASA subgroups in terms of adjusted odds ratios (Tables 1 and 2).

CONCLUSION:

When controlling for prior UC treatment status, efficacy of tofacitinib, based on adjusted odds ratios, was similar regardless of 5-ASA status. These post-hoc analyses were not intended to evaluate incremental benefit of 5-ASA as combination therapy for tofacitinib.
841 The Impact of Inpatient Intravenous Opioids on Future Outpatient Opioid Exposure Among Hospitalized Patients With Inflammatory Bowel Disease
Authors: Dalal Rahul S. , Palchaudhuri Sonali , Snider Christopher , Lewis James , Mehta Shivan , Lichtenstein Gary R.
Published: October 2019

INTRODUCTION:

Patients hospitalized for inflammatory bowel disease (IBD) often receive opioids (OPIs) to control pain. However, OPI use is associated with excess mortality and infections in IBD patients (AJG 2012;107(9):1409-22). Given the high potency of intravenous (IV) OPIs and their unclear impact on future OPI exposure, we sought to determine if IV OPI use is associated with subsequent outpatient OPI prescriptions (Rx) among hospitalized IBD patients.

METHODS:

We performed a retrospective cohort study of patients aged >18 years hospitalized at a large urban academic health system from 3/1/17 to 4/10/18. Patients were included if they were admitted to observation, general medical, general surgical, or gastrointestinal surgical services, had a discharge diagnosis of IBD, and had >1 outpatient office visit in the department of gastroenterology within 12 months of discharge. IBD history, patient-reported pain scores, and demographic, medication administration, and outpatient Rx data were abstracted from the electronic health record. We used multivariable mixed effect logistic regression modeling (MVMELR) to account for repeat encounters and to assess the association between IV OPI exposure and an outpatient OPI Rx provided within 12 months after discharge while adjusting for confounders. IV OPI exposure was represented both as a binary variable and a continuous variable in total IV morphine mg equivalents/length of stay in days (IVMMEs/d). Kaplan-Meier (KM) analysis was performed to compare time to outpatient OPI Rx by inpatient OPI exposure.

RESULTS:

We included 709 encounters among IBD patients between 3/1/17 and 4/10/18. Patient characteristics and unadjusted outcomes by OPI exposure are presented in Table 1. MVMELR demonstrated a significant association between IV OPI exposure (binary predictor: OR 2.9, 95% CI 1.4-5.9; continuous predictor in IVMMEs/d: OR 1.0, 95% CI 1.0-1.1) and an outpatient OPI Rx within 12 months of discharge. Receiving only non-IV OPIs was not associated with an opioid Rx (OR 0.8, 95% CI 0.3-2.4; Table 2). KM analysis demonstrated significant separation in rate curves for OPI Rx between OPI exposure groups (log rank test P < 0.01; Figure 1).

CONCLUSION:

Administration of IV OPIs to hospitalized IBD patients may increase their risk for further OPI exposure after discharge. IV OPIs should be used judiciously in this high-risk population with consideration of appropriate alternatives. Additional research is needed to identify long-term risks of IV OPI use in patients with IBD.
849 Risk of Reoccurrence of Perianal Fistulas in Patients With Crohn’s Disease in the United States: A Retrospective Claims Database Study
Authors: Patel Haridarshan , Latremouille-Viau Dominick , Serre Didier , Lissoos Trevor , Null Kyle D. , Owen Glynn , Campbell-Hill Sarah
Published: October 2019

INTRODUCTION:

Perianal fistulas (PAF) in patients with Crohn’s disease (CD) are associated with morbidity and impaired quality of life. Limited data is available on the risk of PAF among patients with CD and long-term PAF relapse rates.

METHODS:

A retrospective cohort study on US adult patients with CD identified in an US administrative claims database (2001-2018) was conducted. Patients with PAF were identified using diagnosis or procedure codes in medical claims. A PAF episode, starting from the first PAF occurrence, was defined as consecutive PAF-related codes ≤120 days of each other. PAF reoccurrence was defined as a new PAF-related code occurring after a PAF-free period of ≥180 days (proxy for remission) following the end of the first PAF episode. Time from the 180-day PAF-free period to PAF reoccurrence was estimated using KM analyses. A similar analysis was conducted in CD patients with a PAF-free period of ≥360 days.

RESULTS:

5,482 patients with a PAF-free period of ≥180 days after their first PAF episode were included (CD-PAF cohort; mean age = 43.8 years and proportion of males = 51.8%). Over a mean follow-up duration of 2.6 years, 28.8% had a PAF reoccurrence. Estimated rates of PAF reoccurrence in these CD-PAF patients were 23.7%, 32.0%, 42.1% and 47.8% at 1, 2, 5, and 10 years, respectively (Table 1). In the 12 months before first PAF occurrence, 70.8% of CD-PAF patients received non-biologic therapies: corticosteroids (46.5%), antibiotics (44.4%), aminosalicylates (5-ASA) (32.5%) and immunomodulators (IMDs)/immunosuppressants (IMs) (21.1%); 25.3% used ≥1 biologic therapy; and 19.2% had ≥1 CD-related surgery. In the 4 months after first PAF occurrence, 66.5% of CD-PAF patients received non-biologic therapies: antibiotics (39.6%), corticosteroids (30.3%), 5-ASA (27.4%) and IMDs/IMs (22.1%); 31.8% used ≥1 biologic therapy; and 47.2% had ≥1 CD-related surgery. In patients with a longer PAF-free period of ≥360 days (CD-PAF360 cohort), a numerically lower proportion had a PAF reoccurrence (20.5%) and estimated rates of reoccurrence were numerically lower at every time point (32.6% at 5 years and 39.4% at 10 years) vs the CD-PAF cohort.

CONCLUSION:

In this retrospective US claim database analysis, the 5-year and 10-year rates of PAF reoccurrence following PAF remission of ≥180 days were 42.1% and 47.8% among patients with CD, respectively. Patients achieving longer-term remission (≥360 days) had numerically lower rates of PAF reoccurrence.
901 Luminal-Apposing Stents for Benign Intraluminal Strictures: Are We There? U.S. Multicenter Study
Authors: Mizrahi Meir , Kumar Manoj , Tharian Benjamin , Khan Salman Ali , Inamdar Sumant , Sharma Neil , Uppal Dushant , Shami Vanessa M. , Kashif Mahmood Syed , Gabr Moamen , Pleskow Douglas , Berzin Tyler M. , Adler Douglas G.
Published: October 2019

INTRODUCTION:

Benign gastrointestinal (GI) strictures may occur anywhere in the GI tract but are more common in the upper GI tract or post-surgery. Large amount of these strictures will be resistant for conventional treatments such as balloon or mechanical dilation, incisional therapy, steroid injection, and conventional stents. Recently few small studies reported the use of fully covered lumen-apposing metal stents (LAMS) for benign short strictures. The aim of this study was to evaluate the safety and efficacy of LAMS for refractory GI strictures.

METHODS:

Patients and Methods Consecutive patients who underwent LAMS placement for various benign strictures seven tertiary care centers were reviewed retrospectively. The primary outcomes were technical success and initial clinical success of LAMS placement. Secondary outcomes were stent migration, rate of re-intervention, and adverse events.

RESULTS:

Results A total of 51 patients underwent 54 LAMS placement procedures. Median length of the stricture was 8 mm. Previous treatment had failed in 61% of patients. Location of the stricture was found to be at the level of esophagogastric or gastro-Jejunal anastomosis, Pylorus, Ileo-colonic and other in 25%, 21%, 41%, 8% and 5% respectively. A 15 mm × 10 mm LAMS was placed in 32 patients (63%) and a 20 mm × 10 mm LAMS was placed in 19 patients (37%). Median procedure time was 29 min (20-64min). Technical success was achieved in 100% of procedures and initial clinical success was achieved in 98.2% of all procedures. Patient initial clinical success was 49/51 (96%). Mean (range) stent indwell time was 56 (3-126) days. No stent migration occurred during the study period. Adverse events were noted in 10/51 of 25 patients (19%) including pain requiring removal, 1 pain not requiring removal 7; new stricture formation, 1; bleeding, 1). Median follow-up was 162 days after stent placement.

CONCLUSION:

LAMS are safe and effective in the treatment of short benign GI strictures. The use of larger diameter LAMS such as the new 20mm length my improve outcome and reduce the need of re-intervention. Large prospective studies to the determine the optimal stent size and length of treatment are required.
916 Endoscopic Fistulotomy vs. Redo Surgery for the Treatment of Pouch-to-Pouch Fistula in Patients With Inflammatory Bowel Disease
Authors: Lan Nan , Shen Bo
Published: October 2019

INTRODUCTION:

Pouch-to-pouch fistula is a rare yet challenging complication in patients who underwent ileal pouch-anal anastomosis. The aim of this study was to compare endoscopic fistulotomy and redo pouch surgery in the management of pouch-to-pouch fistula.

METHODS:

All consecutive patients with pouch-to-pouch sinuses treated with endoscopic fistulotomy vs. redo surgery from 2000 to 2018 were identified. The primary outcomes were surgery-free survivals and post-procedural complications.

RESULTS:

This historical cohort study included a total of 59 patients (endoscopic fistulotomy, N = 40 and redo surgery, N = 19). Complete resolution of the fistula was achieved in 29/37 (78.4%) patients, partial healing was seen in 8/37 (21.6%) patients with endoscopic fistulotomy while an initial complete healing was obtained in all patients receiving redo surgery. During a foolow-up of 1.4 years, subsequent surgery was needed in 4 (10.0%) patients with endoscopic fistulotomy and 4 (21.1%) patients with initial redo surgery (P = 0.45). Kaplan-Meier surgery-free survivals after initial procedure showed no statistical difference between the two groups (P = 0.42). The rate of adverse events in the endoscopic fistulotomy group was significantly lower than that in the surgery group (5.6% vs. 68.4%, P < 0.001). Patients receiving redo surgery had complications of a higher Clavien-Dindo class as well.

CONCLUSION:

Surgery-free survival were comparable between patients treated with endoscopic fistulotomy and redo surgery, while pouch redo surgery was found to be associated with a higher immediate complete healing rate yet a higher morbidity.
951 Immune Checkpoint Inhibitors-Related Gastrointestinal Toxicity Is Associated With Better Overall Survival and Treatment Response in Cancer Patients
Authors: Alomari Mohammad , Al Ashi Suleiman , Al Momani Laith , Nehme Fredy , Sarmini Muhammad Talal , Young Mark , Funchain Pauline , Romero-Marrero Carlos
Published: October 2019

INTRODUCTION:

Immune checkpoint inhibitors (iCPI) have recently gained an essential role in treating cancer at advanced stages. However, it has been associated with the development of gastrointestinal immune-related adverse events (GI-IrAEs). We aimed in our study to assess the incidence and nature of GI-IrAEs as well as to investigate the effects of developing GI-IrAEs on cancer response to iCPI and overall survival.

METHODS:

We retrospectively identified adult patients diagnosed with end-stage malignancy who were treated with any iCPI at our tertiary center between 8/2014 and 8/2017. Charts were reviewed for baseline characteristics, immunotherapy regimens, response to treatment, development of GI-IrAEs, and patient’s overall 1-year survival. Patients in whom the etiology of GI-IrAEs was unclear were excluded. The overall 1-year survival was calculated from the date of treatment initiation and estimated by the Kaplan-Meier method.

RESULTS:

We included 492 patients with end-stage cancer receiving iCPI. The majority of patients were white 451(92%) with a median age of 64.5 years. (Table 1) GI-IrAEs were in the form of autoimmune hepatitis 18(48.5%), autoimmune colitis 16(43.5%), autoimmune pancreatitis 4 (11%), and a combination of autoimmune colitis and hepatitis in 1 patient. (Figure 1) Brain cancer was associated with the highest risk of GI-IrAEs 16 (44.4%) followed by renal cell carcinoma 7 (19.4%). Nivulomab was associated with the highest risk for GI-IrAEs (55.6%) followed by Pembrulizumab 14 (38.9%). Forty-one percent of Patients who developed GI-IrAEs had an adequate cancer response to immunotherapy compared to 25.7% in patients without GI-IrAEs (P-value = 0.022). Eighty- three percent of patients whose cancer responded to iCPI survived at 1 year compared to 36 % among non-responders (P < 0.0001). Seventy-eight percent of patients who developed GI-IrAEs survived at 1 year compared to 53% in patients without GI-IrAEs (P < 0.005).

CONCLUSION:

The incidence of gastrointestinal toxicity associated with iCPI is second only in frequency to dermatological toxicity. In our study, among the white population with end-stage cancer receiving iCPI, autoimmune hepatitis, colitis, and pancreatitis were fairly common and associated with better cancer response to immunotherapy and overall survival at 1 year. GI-IrAEs might be an indicator of immune system activation, thus may be a reason to continue, rather than discontinue, immunotherapy agents as tolerated.
975 Transjugular Intrahepatic Portosystemic Shunt Placement Is Equally Safe in Obese Patients
Authors: Fahad Hamna , Modaresi Jamak Esfeh , Sarmini Talal
Published: October 2019

INTRODUCTION:

Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement is aimed at controlling complications of portal hypertension in patients with end stage liver disease. In spite of the current obesity epidemic and resultant comorbidities, there is no data in the literature if obesity increases the risk of complications for cirrhotic patients undergoing TIPS. We conducted this study to assess if obesity increases TIPS complications.

METHODS:

Patients were identified using the institutional TIPS registry. A manual, retrospective chart review was done to collect data. We divided patients based on BMI into 1) Underweight: (BMI < 20), 2) Normal Control (BMI: 20–24.99), 3) Overweight (BMI: 25–29.99), 4) Obese (BMI: 30–34.99) and 5) Morbidly obese: (BMI > 35). We then performed a multivariate logistic regression to assess for TIPS outcomes after adjusting for age, gender, cirrhosis etiology and TIPS indication. Outcomes of interest included vascular complications (such as hepatic and portal vein thrombosis); hematological complications (such as bleeding and hemolysis); ischemic liver injury; respiratory distress post procedure; need for revision within 6 months; incidence of TIPS stenosis; infections and incidence of hepatic encephalopathy post TIPS.

RESULTS:

329 patients underwent an elective TIPS procedure at our institute between 2013 and 2017. After excluding patients with missing data, 300 patients were identified and were divided based on BMI into five groups as mentioned above: Control (n = 92), underweight (n = 13), overweight (n = 89), obese (n = 55) and morbidly obese (n = 51). The mean age for each group was noted to be: (55.83, 53.69, 57.25, 58.45, and 56.20) respectively. The control group was noted to have more females compared to the underweight group (38.2% vs. 16.1%), but less females when compared to the rest of the groups: (38.2%, 50.9%, 60.8%). Using multivariate logistic regression there was no statistically significant increased risk for complications after TIPS in patients with increased BMI compared to the control group, P-value > 0.05. (Table 1. Comparison of post TIPS complications between all groups).

CONCLUSION:

BMI of patients with TIPS related complications is not significantly higher than those without complications. Obesity does not play a role in post TIPS complications.
977 Predictors of Response to Direct Acting Anti-Viral Therapy in Patients With Decompensated Hepatitis C Cirrhosis
Authors: Debnath Prasanta , Chandnani Sanjay , Rathi Pravin , Nair Sujit , Udgirkar Suhas
Published: October 2019

INTRODUCTION:

The introduction of direct-acting antiviral (DAA)-based therapies for chronic hepatitis C virus (HCV) infection has revolutionized the approach to HCV treatment, resulting in highly efficacious and well-tolerated therapy for nearly all patients. Patients with a history of decompensated cirrhosis represent a unique subset of patients with a worse response to HCV therapy compared with those who have compensated cirrhosis or chronic HCV infection. Decompensated cirrhosis due to HCV is a difficult to treat population. At present, there is no gold standard predictors of response to Direct Acting Anti-virals (DAA). We conducted this study to look for factors responsible for improvement in state of decompensation post DAA therapy, i.e. attainment of Child-Turcotte-Pugh (CTP) class A from CTP class B or C.

METHODS:

Retrospective analysis was conducted for patients of decompensated HCV cirrhosis (48 patients of CTP class B and 14 patients of CTP class C). We collected demographic, clinical, treatment response, and laboratory data from patients, which included age, BMI, LFT, INR, GFR, MELD score, response to therapy (SVR12), presence of ascites, encephalopathy were noted for recruited decompensated HCV cirrhosis and tested their associations with patient outcomes at 24 weeks post-treatment. Patients were given Sofosbuvir combination treatment with Daclatasvir / Ledipasvir / Velpatasvir and/or Ribavirin according to genotype, for 12 weeks, where Ribavirin was used and rest 24 weeks.

RESULTS:

Total 62 patients of decompensated HCV cirrhosis patients recruited, with males 54%, Median age 48 years. 48 patients were CPT class B whereas 14 patients of CPT class C. Patients with MELD score < 10, 10–15 and >15 were 21 (33.8%), 28 (45.1%) and 13 (21.1%) in pre-treatment and 23 (37%), 30 (48.3%) and 9 (14.7%) in post-treatment period respectively. Post-treatment 34 patients (54.8%) turned into CTP class A, 25 (40.3%) and 3 (4.9%) remained in CTP class B & C. Factors associated with favorable prognosis were male sex, baseline albumin, bilirubin, MELD score, presence of ascites.

CONCLUSION:

This study showed that oral DAAs were able to reverse liver dysfunction in patients with decompensated HCV cirrhosis in more than half of our patient cohort and favoured use of treatment in such patients. The longer term benefits of therapy need to be ascertained though.
999 De-Livering an Assessment of Internet Information for Patients on Non-Alcoholic Fatty Liver Disease
Authors: Tabbara Nadeem , Clarke Lindsay , Baumgartner Scott , Szvarca Daniel , Basso Jessica , Dawit Lillian , Borum Marie
Published: October 2019

INTRODUCTION:

Non-alcoholic fatty liver disease (NAFLD) is currently the most common liver disease in the United States. Given the potential for significant morbidity and mortality risk, individuals increasingly access online sources for self-education. This study evaluated the quality, readability, and content of readily accessible online resources on NAFLD using validated assessment tools.

METHODS:

A search of the terms “fatty liver” was executed using the Google search engine to obtain the first 100 websites. Websites that were non-accessible, included videos without transcripts, focused on veterinary topics or were duplicates were excluded. Websites were categorized by intended audience: patient versus professional. Quality was evaluated using the validated DISCERN instrument with DISCERN scores rated as Excellent 56-75, Good 36–55, Poor < 36. Readability was determined using the validated Flesch-Kincaid Grade Level Calculation. Statistical analysis was conducted using a two-tailed Fisher’s Exact Test and a Two-Sample T-test, with a P-value set at <0.05.

RESULTS:

100 websites were evaluated with 88 sites meeting inclusion criteria. 52 (59.1%) sites were intended for patients and 36 (40.9%) were for medical professionals. The average Flesch-Kincaid grade level was 12.7, with a significant difference (P = 0.009) between patient (11.9 grade level; range 6.3–18.6) and professional (13.8 grade level; range 7–19.7) websites. Professional sites were significantly (P = 0.0009) more likely to provide references (52.8%) than patient sources (17.3%). The mean DISCERN score was Good 47.7 with no significant difference in measured quality between patient (47.7; range 32–74) and professional (47.8; range 28–72) websites.

CONCLUSION:

Online NAFLD resources are readily available for patients and professionals. Based on the validated DISCERN tool, the quality of website information as rated as good. However, the patient reading level of medical information exceeded the NIH 6th grade reading level recommendation. Online sources targeted towards patients should be written in more patient-centered language. This study highlights the potential need for improvement in the current online medical information available to both patients and professionals regarding NAFLD and its spectrum of disorders. In addition, most websites disseminating medical information should be revised to include validated references and improve quality content.
1004 Does Hospital Teaching Status Influence Risk Factors and Incidence Rate for 30-day Readmission for Hepatic Encephalopathy?
Authors: Mehta Neal , Varghese Ron T. , Kamoga Roy , Khasawneh Khaled , Tharian Benjamin , Garg Shashank , Deneke Matthew G. , Inamdar Sumant
Published: October 2019

INTRODUCTION:

Literature suggests that an index admission with Hepatic Encephalopathy (HE) is associated with all-cause readmission and increased mortality in patients with cirrhosis. Teaching hospitals may have higher readmission rates compared to non-teaching hospitals. We determined the 30-day all-cause readmission rate and risk factors for adults admitted with a principal diagnosis of HE in metropolitan teaching and non-teaching hospitals.

METHODS:

We utilized the Nationwide Readmission Database to identify admissions with a principal diagnosis of HE (ICD-9 572.2). Applicable admissions were all adults (age ≥ 18) from 01/01/2014 to 11/30/2014. Patients who died during index admission, those with missing covariates, or admission to non-metropolitan hospitals were excluded. All-causes including HE readmissions within 30-days of an index HE admission were analyzed. Statistical analysis was completed with Stata 15 (StataCorp, College Station, TX). Predictors for readmission were determined using a multivariate logistic regression model following sequential step-wise elimination of covariates including demographics, comorbidities, hospital characteristics, length of stay (LOS) for index admission, and the modified Elixhauser Comorbidity Index.

RESULTS:

A total of 19,047 patients met criteria for inclusion. There were 6,362 all-cause readmissions (33.40%) within 30-days of the index HE admission. The readmission rate for patients discharged from a teaching hospital and readmitted to any hospital was 33.65% with non-teaching hospitals at 32.95%. There was not a statistically significant difference (P = 0.32) between the readmission rate for patients discharged from teaching and non-teaching hospitals. There was no statistical difference in readmission for HE (P = 0.78). For non-teaching hospitals, discharge against medical advice, age between 35 and 65, and CKD were predictors for readmission. For teaching hospitals, females, age between 35 and 65, Medicaid insurance, LOS between 7 and 14 days, and CKD predicted readmission.

CONCLUSION:

Nearly 1 in 3 individuals admitted to a metropolitan hospital (non-teaching or teaching) with a principal diagnosis of HE was readmitted. While there was not a difference in the readmission rate, the risk factors for readmission at teaching and non-teaching hospitals were slightly different. Development of targeted interventions for sub-populations at high risk for readmission, may help to decrease healthcare cost, morbidity and mortality.
1086 Venous Thromboembolism Trends and Impact in Patients With Cirrhosis: Analysis of the National Inpatient Sample Database 2003-2014
Authors: Greenberg Ian , Quintero Luis Diaz , Tafur Alfonso
Published: October 2019

INTRODUCTION:

Despite the decreased synthesis of coagulation factors and high bleeding risk in patients with cirrhosis, they are not free of venous thromboembolism (VTE) risk. The impact of VTE in patients with cirrhosis is not well understood, even less so the impact of acute VTE during hospitalization. This study set out to establish the impact of inpatient VTE occurrence in mortality, bleeding, length and cost of hospitalization in patients with cirrhosis.

METHODS:

We identified individuals ≥ 18 years old from the 2003-2014 National Inpatient Sample database with a diagnosis of cirrhosis using ICD-9-CM codes. Cirrhosis, acute deep vein thrombosis of extremities and acute pulmonary embolism diagnoses were allocated if present among the top 10 admission diagnoses. Demographics and inpatient outcomes of patients with VTE were compared to those without VTE. We used SPSS 25 to calculated odds ratios (OR) with confidence intervals (CI), and trend analysis.

RESULTS:

A total of 1,165,369 cirrhotic patients were included (weighted cases = 5,594,565). 11,049 (0.9%) VTE cases were diagnosed. Patients with VTE were older (61.9 vs 58.4 years, P < 0.0001), and less likely females (36.8% vs 39%, P < 0.0001). Patients with VTE were more likely to die during the hospitalization (OR 1.6 [CI 95% 1.5-1.71, P < 0.0001]), to have intracranial bleeding (OR 1.3 [CI 95% 1.03–1.64, P = 0.02]), retroperitoneal bleeding (OR 2.36 [CI 95% 1.68–3.3, P < 0.0001]), had longer inpatient stay (9.6 vs 6.0 days, P < 0.0001), and higher costs (72,434 vs 41,670 USD, P < 0.0001). There was an increasing trend of inpatient VTE per year (0.27% 2003 vs 1.16% 2014, P < 0.0001) but a decreasing trend in inpatient mortality per year in cirrhotic patients with VTE (17.6% 2003 vs 9.2% 2014, P = 0.0001).

CONCLUSION:

VTE occurrence is associated with increased inpatient mortality, intracranial bleed, retroperitoneal bleed, length and cost of hospitalization. More thorough VTE prophylaxis strategies may need to be implemented in patients with cirrhosis.
1126 Preoperative Endoscopic Findings in Veterans Undergoing Bariatric Surgery: Prevalence and Predictors of Barrett's Esophagus
Authors: Ozeki Katharine , Tran Sally , Cheung Ramsey , Eisenberg Dan
Published: October 2019

INTRODUCTION:

The role of preoperative esophagogastroduodenoscopy (EGD) in patients seeking bariatric surgery remains unclear, as recommendations are based on data from a younger, largely female population. We aim to characterize and determine the frequency of EGD findings in a predominantly older, male Veteran population undergoing bariatric surgery.

METHODS:

This is a single-center retrospective analysis of Veterans who underwent Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy at a Veterans Affairs hospital between January 2008 and December 2017. All patients received a preoperative EGD. Data abstracted included demographics, comorbidities, preoperative laboratory values and EGD reports. Univariate and multivariate analyses using odds ratio (OR) were compared between those with a normal EGD and Barrett’s esophagus.

RESULTS:

Of the 260 Veterans included in our cohort, most were male (75%) aged 54.0 ± 9.0 years-old with a BMI of 44.9 ± 7.0 kg/m2 (Table 1). Most Veterans identified themselves as Caucasian (73.5%), followed by African American (9.2%), Hispanic (7.3%), Native American (1.2%), Asian (0.8%) and other (8.1%). The majority had hypertension (78.9%), previously smoked (63.9%), used a proton pump inhibitor (PPI) (53.1%) within 6 months of surgery, had gastroesophageal reflux disease (GERD) (49.2%) and diabetes (47.3%). One third of Veterans had a completely normal preoperative EGD. Common EGD findings included gastritis (35.8%), hiatal hernia (25.8%), esophagitis (20.8%), duodenitis (10.4%), Barrett’s esophagus (7.4%), H. pylori infection (4.6%) and gastric intestinal metaplasia (0.8%). On univariate analysis alone, male gender (OR 0.55, P = 0.041) and those with hypertension (OR 0.50, P = 0.025) were less likely associated with a normal EGD. On both univariate and multivariate analyses, those who recently used a PPI were also less likely to have a normal EGD (OR 0.38, P = 0.001; OR 0.030,P < 0.001, respectively). In contrast, on both univariate and multivariate analysis, increasing age (OR 1.08, P = 0.020; OR 1.08; P = 0.040, respectively), recent PPI use (OR 5.20, P = 0.010; OR 10.1, P = 0.002, respectively) and recent histamine receptor 2 blocker (H2B) use (OR 5.58, P = 0.007; OR 8.87 P = 0.014, respectively), were associated with Barrett’s esophagus (Table 3).

CONCLUSION:

Preoperative factors can be used to identify patients at risk for gastroesophageal pathology. Our data support preoperative EGD in select populations that include older males with recent PPI or H2B use.