bluuebunny/crossref_metadata_2025_split huggingface dataset:
839 Response and Healthcare Resource Utilization in Inflammatory Bowel Disease Patients Treated With Either Infliximab or Vedolizumab
Authors: Sarles Harry E. , Hardin Thomas C. , Kuten Samantha A. , Van Anglen Lucinda J. 
Published: October 2019

INTRODUCTION:
Both infliximab (IFX) and vedolizumab (VDZ) are FDA-approved for treatment of inflammatory bowel disease (IBD) in adults. Much of the published data on clinical outcomes for either IFX or VDZ compare the biologic agent against more traditional therapies rather than alternative biologics. The aim of this study was to evaluate clinical response and healthcare resource utilization (HRU) in IBD patients (pts) treated with either IFX or VDZ for 12 months (mos).

METHODS:
We performed a review of adult Crohn’s disease (CD) and ulcerative colitis (UC) pts who initiated treatment with either IFX or VDZ from 2016-2018 at a large multicenter, gastroenterology private practice. Those who persisted on therapy for 12 mos were identified. Pts were case-matched 1:1 based on age, gender, diagnosis, and baseline disease severity scores using the partial Mayo (pMayo) for UC and the modified Harvey-Bradshaw Index (mHBI) for CD. Primary endpoints were changes in disease activity at 3, 6, and 12 mos compared to baseline, and IBD-related HRU, defined as emergency department (ED) visits, and hospitalizations during the 12 mos. Additionally, adverse drug reactions (ADR) and infections were assessed.

RESULTS:
Case-matching yielded 35 IFX (16 CD, 19 UC) and 35 VDZ (16 CD, 19 UC) pts for further assessment. Demographics were similar between groups: mean age 38 ± 20 vs 40 ± 15, male gender 54% vs 51%. Baseline scores were similar as noted in Figure 1. In the overall assessment of response between groups, both IFX and VDZ in CD were associated with a reduction in HBI score of >60% at 3 mos. IFX and VDZ use in UC were associated with reductions in pMayo scores at 3 mos of 56% and 44%, respectively. These substantial reductions were sustained through 12 mos. IFX-treated pts had 4 IBD-related ED visits with 1 hospitalization, while VDZ-treated pts had 5 IBD-related ED visits and 4 hospitalizations. Infection rates were similar with 8 infections in IFX pts (23%) and 7 in VDZ pts (20%); 1 VDZ infection led to hospital admission. Thirteen (5 IFX, 8 VDZ) non-serious infusion-related ADRs were reported with no difference between treatment groups.

CONCLUSION:
The data demonstrate similarity in response and healthcare resource utilization over time with use of IFX or VDZ in the treatment of IBD patients. Although the number of case-matched patients in this study is limited and the population is restricted to responders, resource utilization was noticeably low. Additional study is warranted.
843 Crohn’s Strictures Open With Anti-Mycobacterial Antibiotic Therapy (AMAT): A Retrospective Review
Authors: Agrawal Gaurav , Collyer Rhys , Clancy Annabel , Gunaratne Anoja W. , Lampe Stephan , Borody Thomas 
Published: October 2019

INTRODUCTION:
Approximately one third of patients with Crohn’s disease (CD) will develop strictures within 10 years of diagnosis, commonly in the terminal ileum and ileocecal valve (ICV). Strictures often lead to abdominal pain, obstruction and are a risk factor for developing internal fistulae and cancer. Current treatment involves endoscopic balloon dilatation or strictureplasty. However, this may result in postoperative complications or recurrence. Recent evidence suggests that Mycobacterium avium ssp paratuberculosis may be a causative agent of CD and anti-mycobacterial antibiotic therapy (AMAT) has been shown to induce remission significantly better than placebo. The effects of AMAT on strictures has not been reported.

AIM:
To report the outcomes of AMAT in patients with CD and an ileal stricture/s.

METHODS:
This is a single centre retrospective (January 1995-December 2018) case review of patients diagnosed with CD, who had ileal stricture on colonoscopy and were treated with AMAT which comprised a combination of clarithromycin, rifabutin, and clofazimine, some with added ethambutol, ciprofloxacin, metronidazole or tinidazole. Symptoms, colonoscopy reports, biochemistry and concurrent medications were reviewed and recorded at pre-treatment and 6, 12, 18 and >24 months on treatment.

RESULTS:
Forty-three patients (24 male, 16-56 yrs) with an average age of 31 yrs, and 5 yrs (0-27 yrs) after diagnosis were included. At pre-treatment, 17 patients had stricturing of the ICV, 25 had stricturing of the ileum and one had stricturing in both the ileum and ICV. Of the patients who had follow up colonoscopy data (N = 32), after >24 months of AMAT, 22/32 patients (69%) had complete resolution and 2/32 patients had partial resolution of their strictures. Interestingly, after resolution of stricture on AMAT one patient ceased treatment. At 36 month follow up post cessation of AMAT the patient’s ileocecal stricture had returned. Further treatment with AMAT resulted in resolution of the stricture.

CONCLUSION:
AMAT for CD is effective in opening Crohn’s strictures avoiding the need for repeated dilatations or surgery. These observations suggest that stricturing in CD may be mediated by mycobacterial infection, as reported in tuberculosis strictures. To our knowledge, CD strictures have not previously been reported to open using medical therapy. Further prospective documentation is required to better define this positive effect of AMAT, including rate of resolution.
846 Real World Use of Tacrolimus in Combination With Biologicals Is Beneficial in the Treatment of IBD
Authors: Burstiner Shane , Schwimmer David , Alvarez Lybil Mendoza , Tuna Kubra , Hosseini-Carroll Pegah , Glover Sarah C. 
Published: October 2019

INTRODUCTION:
The use of relatively moderate to high doses of tacrolimus in treating refractory inflammatory bowel disease has been reported in multiple studies. However, the efficacy and safety of using low dose (< =2 mg/day, orally) has not been well substantiated, particularly when used in combination with a biologic. The use of relatively moderate to high doses of tacrolimus in treating refractory inflammatory bowel disease has been reported in multiple studies. However, the efficacy and safety of using low dose (< =2 mg/day, orally) has not been well substantiated, particularly when used in combination with a biologic.

METHODS:
This was a retrospective, observational single center study involving the charts of 124 adults with Crohn’s disease (CD) or Ulcerative Colitis (UC) as diagnosed by endoscopic evaluation, with no history of organ transplant, who had at least two office visits to our clinic. 34/128 patients were eliminated due to insufficient data sets, lack of follow up, or inconsistent usage of the drug. Tacrolimus was administered orally in dosages ranging from 1 mg/day to 9 mg/day. 77/90 (85.6%) patients received concomitant treatment with a biologic (anti-TNF, anti-integrin blocker, or anti-IL-12/23). We utilized a scoring allocation system that relied on patient completion of SIBDQs, fecal calprotectin levels, the physician’s impression of the effectiveness of tacrolimus, and radiographic, pathological, and endoscopic evidence of disease activity. The score ranged from 0-4.0, with 2.0 representing the patient’s baseline state of health prior to starting tacrolimus. Scores above 2 represent improvement in their IBD on therapy. The primary endpoint was the proportion of patients with improvement after starting tacrolimus. Secondary study endpoint was the occurrence of side effects.

RESULTS:
Overall, 48/82 (58.5%) of patients showed improvement on tacrolimus by standarized score when compared to their baseline. 14/82 (17.1%) of patients maintained their pre-tacrolimus level of health. 20/82 (24.4%) demonstrated a progression in disease activity while taking tacrolimus. 8 patients (8.9%) required surgical resection of bowel between 3 and 20 months following initiation of tacrolimus. Overall 7/82 (8.5%) patients experienced major side effects related to tacrolimus.

CONCLUSION:
Low to medium doses of tacrolimus (1-4 mg/day) likely enhance the effectiveness of biologic medications, however, well designed, placebo-controlled trials would be required to definitively confirm this finding.
852 Changing Preclinical Medical Student Perspective on IBD Through a Novel Patient-Centered Education Panel
Authors: Horrigan Jamie , Leong Karissa , Calderone Jessica , Winston Linda , Zhu Xinjun , Tadros Micheal 
Published: October 2019

INTRODUCTION:
Background & Purpose: Leaders in medical education strive to develop more interactive and efficacious teaching methods as preclinical teaching typically occurs in passive didactic lectures. The pathophysiology, diagnosis and treatment of diseases are explored in textbooks. However, the effect of disease on patients’ lives and the difficulty of managing chronic conditions are often not conveyed. Preclinical students would benefit from more patient interaction as patient care is the essence of being a physician. In this patient-centered educational panel, we focus on Inflammatory Bowel Disease (IBD).

LEARNING OBJECTIVES:
1. Understand how IBD impacts patients’ lives
2. Expose students to the challenges of living with IBD from patient and caregiver perspective
3. Recognize how the Crohn’s & Colitis Foundation supports IBD patients
4. Review the role of a multidisciplinary approach in treating IBD patients and the potential role of complementary medicine

METHODS:
In 2017 and 2018, Albany Medical College incorporated an IBD patient panel into the preclinical gastrointestinal curriculum. Students (n = 140), having already been lectured on IBD, attended an interactive 2-hour panel in which patients, caregivers, physicians and the Crohn's & Colitis Foundation shared their experiences. Students then completed a Qualtrics survey.

RESULTS:
Student responses indicated that 96% strongly agreed/agreed that learning from patients helped to understand the complexity of managing a chronic disease, 89% strongly agreed/agreed that the patient panel supported traditional IBD lectures well and 94% strongly agreed/agreed that future students would benefit from a similar panel (Figure 1). Additionally, 73% strongly agreed/agreed that there is a role for complementary medicine (Figure 2). Student narratives suggested that the panel enriched their medical education (Figure 3).

CONCLUSION:
This panel showcased the challenges of diagnosing, managing and living with IBD. Learning about chronic disease from a patient encouraged future physicians to consider how the disease affects many aspects of one’s life. The panel challenged students to consider a role for complementary medicine in IBD. Survey responses found that the panel enhanced students’ understanding of IBD beyond what could be learned from traditional lectures and textbook readings. The success of this panel illustrates that patient-centered learning enriches preclinical education and should be incorporated in medical curriculum moving forward.
856 Evaluation of Paired and Separated Endoscopic Reads at Baseline and Week 14 in the Exploratory BERGAMOT Induction Cohort
Authors: Mishkin Daniel S. , Schreiber Stefan , Daperno Marco , Oh Young S. , Hussain Fez , Hassanali Azra , Lacey Stuart , Li Regan , Reinisch Walter 
Published: October 2019

INTRODUCTION:
Treatment guidelines recommend that Crohn’s disease evaluation and treatment decisions should include endoscopic evaluation in conjunction with clinical and laboratory assessment. Previously, an adjudicated central read model (CRM) for evaluating Simple Endoscopic Score for Crohn's Disease (SES-CD) that included a local reader and at least 1 central reader (CR) was found to reduce placebo rates and variability and increase treatment response rates versus single reader models (1). This study explored the impact on scoring by blinded reading of paired endoscopic reads (i.e. simultaneous assessment of pre- and postinduction treatment endoscopic videos) versus unpaired reads scored by the CRM.

METHODS:
Patients in this analysis (n = 63) were a subset from the exploratory BERGAMOT induction cohort, who were randomized 2:2:1 to receive subcutaneous etrolizumab 105 mg every 4 weeks (n = 24); etrolizumab 210 mg at weeks 0, 2, 4, 8, and 12 (n = 24); or placebo (n = 15). Three CRs performed the paired endoscopy readings. The unpaired reads were evaluated using the CRM and included a predefined sliding threshold to trigger adjudication of discordant scores by a second CR. All readers were blinded to treatment arm, timing of the endoscopy, and the other reader’s assessments.

RESULTS:
In the overall population, 48% had ileocolonic disease, 30% had colonic disease, and 22% had disease restricted to the ileum. Prior treatment for Crohn’s disease included anti-TNFs (73%), oral corticosteroids (49%), or nonbiologic immunosuppressants (27%). In general, the mean baseline and week 14 SES-CD evaluated by the paired read model were higher than those assigned by the CRM. Differences between models in assigning categorical thresholds were more varied (Table 1). The placebo rates of ≥ 50% SES-CD decrease from baseline, SES-CD ≤ 4, and SES-CD ≤ 2 were similarly low (0%-6.7%) with either the unpaired CRM or the paired endoscopy model. More patients achieved ≥ 50% SES-CD decrease from baseline with etrolizumab treatment using the CRM compared with the paired read model (21% vs 13%, respectively).

CONCLUSION:
Based on data generated by experienced CRs in a small subset of patients, both paired and unpaired central reading of CD endoscopic videos resulted in very low placebo response rates. However, unpaired central reading resulted in increased treatment response rates compared with a paired read paradigm.
859 The Impact of Inflammatory Bowel Disease on Admissions With Clostridium difficile Infection: A Nationwide Database Study
Authors: Abdalla Abubaker O. , Abdallah Mohamed , Narala Sai B. , Doshi Rajkumar , Gullapalli Nageshwara 
Published: October 2019

INTRODUCTION:
Clostridium difficile infection (CDI) is one of the most common healthcare-associated infections. It contributes to significant morbidity and mortality amongst hospitalized patients in the United States. Prior studies suggest worse outcomes of CDI in patients with inflammatory bowel disease (IBD). We conducted this study to evaluate the outcomes of CDI in patients with IBD from a nationwide sample (2012-2015).

METHODS:
The National Inpatient Sample (NIS) database between January 2012 and September 2015 was queried for CDI admissions using the International Classification of Diseases, Ninth Edition, Clinical Modification [ICD-9-CM] codes 008.45, 555.X, 556.X for diagnoses of CDI and IBD In-hospital mortality, use of hospital resources, length of stay (LOS), and total charges in USD were assessed. Outcomes were adjusted for risk factors and comorbid conditions.

RESULTS:
The study included 1,311,085 patients who were admitted between 2012 and 2105 for CDI. Out of all of the patients, 54,655 (4.2%) had concurrent IBD. After adjusting for confounding variables, the in-hospital mortality was higher [Odd Ration (OR): 1.45, 95% CI: 1.34-1.57 P < 0.001] for patients with IBD and they were more likely to have toxic megacolon (13.3% vs 4.2% P < 0.001). However, in CDI without IBD, LOS was longer [10.5 vs. 9.3 days, P < 0.001] and mean cost of hospitalization was significantly higher.

CONCLUSION:
In a nationwide population study, admissions with CDI, patients with a concurrent diagnosis of IBD had higher in-hospital mortality and were more likely to have toxic megacolon compared with non-IBD. However, hospital length of stay and total charges in USD were more in non-IBD. The discrepancy between high mortality and lower LOS and total charges in IBD vs non-IBD can be due to early mortality during hospitalization, the clinical presentation with severe CDI on admission, and/or development of grave complications in patients with CDI and IBD. Studies are needed to better understand the impact of IBD on CDI. Studies are also needed to examine the role of aggressive treatment of CDI in patients with IBD early in the course of hospitalization.
864 Simultaneous Biliary and Liver Parenchymal Evaluation in Post Liver-Transplant Population Using Endoscopic Ultrasound-Guided Liver Biopsy and Endoscopic Retrograde Cholangiopancreatography in a Single Session Approach
Authors: Ellis Daniel J. , Therapondos George , Shah Janak N. , Cohen Ari , Galliano Gretchen E. , Romero Ricardo V. , Evans John A. , Kumar Sunayana Udaya , El Chafic Abdul 
Published: October 2019

INTRODUCTION:
Liver test elevations occur post-liver transplantation (LTx) secondary to a variety of etiologies including parenchymal, biliary or vascular dysfunction. Workup often includes a multi-step evaluation including imaging, liver biopsy and evaluation of the biliary system. Endoscopic ultrasound-guided fine needle biopsy of the liver (EUS-LB) is a novel technique that has been shown to be safe and effective. Herein, we report our experience with a single-session EUS-LB coupled with endoscopic retrograde cholangiopancreatography (ERCP) in the evaluation of abnormal liver function tests in the post-LTx population.

METHODS:
This is a retrospective analysis of electronic medical record over 2-year period (1/2017 – 5/2019). EUS-LB was performed in addition to ERCP for the evaluation and treatment of elevated liver tests and suspected biliary abnormality. EUS-LB was obtained using 19-gauge core biopsy needle (Sharkcore, Medtronic, Sunnyvale, CA. or Acquire, Boston Scientific, Marlborough, MA.) via modified one pass, one actuation wet suction technique.

RESULTS:
Thirty-nine patients underwent simultaneous EUS-LB and ERCP (mean age 52 ± 15 years; 62% female; mean BMI 27) after an average of 61 (1-432) weeks post-LTx. Nineteen patients (49%) were on aspirin. The mean EUS-LB and ERCP procedure time were 15 ± 12 and 21 ± 13 minutes respectively. EUS-LB was performed from a single lobe in 29 patients (74%) via 1 pass in 23 patients and 2 or 3 passes in the remainder. Ten patients (26%) underwent EUS-LB via 2 or 3 passes of both lobes. Adequate yield for histopathology in 37 of 39 (95%). Two specimens were inadequate due to defective needles. The mean specimen aggregate length was 30 ± 19 mm, longest intact core was 19 ± 11 mm and complete portal tracts were 16 ± 7.8. ERCP abnormalities were anastomotic stricture (33; 84.6%), debris (5; 12.8%), choledocholithiasis (4; 10.3%), and biliary leak (2; 5.1%). Histology demonstrated acute rejection (10; 27.0%), cholestasis (11; 29.7%), non-specific hepatitis (12; 32.4%), chronic rejection (2; 5.4%), and alcoholic hepatitis (1; 2.7%). Procedural complications were pancreatitis (2; 5.1%), cholangitis due to occluded stent (1; 2.6%), and hematoma requiring transfusion but no intervention (1; 2.6%).

CONCLUSION:
Simultaneous EUS-LB and ERCP evaluation of post-LTx patients is an effective technique for the assessment of abnormal liver function tests, obviating the need for separate evaluations with potential delays of care and prolonged hospitalization.
866 Safety and Efficacy of the Novel Endorotor® Mucosal Resection System: First Multicenter USA Experience
Authors: Ayub Kamran , Diehl David L. , Infantolino Anthony , Enslin Sarah , Bittner Krystle , Tariq Raseen , Ashan Nayab , Aslam Rida , Kaul Vivek 
Published: October 2019

INTRODUCTION:
The EndoRotor® (ER) non-thermal tissue resection device (Interscope Inc., USA) is a novel mechanical endoscopic resection system developed for use in the gastrointestinal tract for removal of neoplastic or pre-neoplastic tissue. It utilizes adjustable suction and a rotary cutting blade to precisely resect mucosal and submucosal tissue. Our aim was to assess the technical feasibility, safety and efficacy of endoscopic mucosal resection (EMR) using the ER device.

METHODS:
This was an IRB-approved multicenter retrospective review of prospectively collected data of patients that underwent EMR with ER device from 11/2018 to 06/2019 at 4 high-volume US centers. Patient-specific data were collected including demographics and indication for EMR. Procedural and histopathological data were also obtained.

RESULTS:
During the study period, 35 patients underwent EMR with ER of 42 lesions. Patient characteristics described in Table 1. Most common indications for EMR were colon polyps (n = 15, 42.9%) and Barrett’s Esophagus (n = 10; 28.6%). Most (n = 25; 71.4%) patients had a prior resection attempt for the same indication using standard techniques; ER-EMR was successful in all these difficult cases. The majority (n = 32; 91.4%) had a single lesion resected; 3 patients had multiple lesions resected in same session. ER-EMR was technically feasible in all patients, with complete resection achieved in 33 (94.3%) patients (Table 2). Mean lesion size was 2.1 cm (range = 0.35–4 cm). Most frequent histopathological findings in the colon were tubular adenoma (n = 10; 45.5%) or sessile serrated adenoma (n = 5; 22.7%). Most common esophageal pathology in BE patients was high-grade dysplasia (n = 5; 50%). Intra-procedural bleeding was observed in 9 (25.7%) patients, all managed endoscopically. No ER-related perforation occurred. Post-procedural complications were reported in 7 patients (20%), including self-limited chest pain (n = 1), mild stenosis (n = 3), and delayed bleeding (n = 3). Of patients that have undergone a follow-up endoscopy (n = 13; 37.1%), no residual lesion was seen in majority (n = 10; 76.9%).

CONCLUSION:
The Endorotor® device is a novel, effective and safe non-thermal EMR technique that allows efficient endoscopic resection of flat and polypoid lesions, especially those with submucosal scarring. Our initial experience suggests it has a promising role in the endoscopic management of both naïve and difficult to remove luminal lesions in the foregut and in the colon.