bluuebunny/crossref_metadata_2025 huggingface dataset:
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.
870 The Efficacy and Safety of Endoscopic Submucosal Dissection for Early Gastric Cancer in Patients With Cirrhosis: A Systematic Review and Meta-Analysis
Authors: Laoveeravat Passisd , Perisetti Abhilash , Vutthikraivit Wasawat , Garcia-Saenz-de-Sicilia Mauricio , Garg Shashank , Thandassery Ragesh , Inamdar Sumant , Wongjarupong Nicha , Tharian Benjamin
Published: October 2019

INTRODUCTION:

Cirrhosis is known to increase the risk of bleeding and mortality from procedures. Endoscopic submucosal dissection (ESD) is an approved minimally invasive treatment of early gastric neoplasm. The safety and complications of ESD in cirrhotics in this setting has not been mentioned in the guidelines. We aimed to address it in this meta-analysis.

METHODS:

We searched the databases of MEDLINE, EMBASE, and CENTRAL from inception to May 2019. A manual review of included studies and references were performed. The inclusion criteria were published studies comparing the efficacy and safety of ESD for gastric cancer in cirrhosis and non-cirrhotics. The outcomes were En bloc resection, R0 resection, post-ESD bleeding, perforation, and mortality rate. Data from each study were combined using the random-effects, generic inverse variance method of DerSimonian and Laird to calculate pooled risk ratio (RR) and 95% confidence intervals (CI).

RESULTS:

Of 14 included observational studies, four included compensated cirrhosis patients and ten did not mention cirrhosis status. Major etiologies of cirrhosis were hepatitis B infection (49%). Mean platelet counts in compensated cirrhotics was 113000/uL. Cirrhotics have higher risk of post-ESD bleeding compared to others with pooled RR (95% CI) of 1.43 (1.02-2.00, I

2
= 0%) (Figure 1). In subgroup analysis of compensated cirrhosis, the bleeding risk is not different between the groups, pooled RR (95% CI) of 1.22 (0.70-2.12, I

2
= 0%) (Figure 2). The data of decompensated cirrhosis is not available. On the contrary, perforation risk is comparable between the groups with pooled RR (95% CI) of 2.08 (0.51-8.43, I

2
= 0%). ESD procedure time is not different between two groups. We found that the efficacies, En bloc and R0 resection, are not different between cirrhosis and non-cirrhosis with pooled RR (95% CI) of 1.01 (0.97-1.04, I

2
= 12.1%) and 0.98 (0.92-1.04, I

2
= 0%), respectively. The procedure related mortality rate in both cirrhosis and non-cirrhosis patients are 0%.

CONCLUSION:

Post-ESD bleeding in cirrhosis is a concerning complication as expected in early gastric cancer; but the risk of bleeding in compensated cirrhosis is similar to non-cirrhotics. Perforation and mortality are not different compared to controls. In terms of efficacy, no differences are found between patients with and without cirrhosis. Further studies on subgroup analysis of decompensated cirrhosis are warranted.
874 Sensitivity of Endoscopic Modalities for Diagnosis of Malignant Biliary Strictures: Experiences From Referral Hospitals in Eastern and Western Countries
Authors: Angsuwatcharakon Phonthep , Ahmed Osman , Maytapa Jeerawat , Ross William , Weston Brian , Ridtitid Wiriyaporn , Kongkam Pradermchai , Rerknimitr Rungsun , Stroehlein John , Lee Jeffrey H.
Published: October 2019

INTRODUCTION:

Indeterminate biliary strictures require further investigations to exclude malignancy. Cholangioscopy allows direct visualization of the bile duct as well as the ability to target the specific area for biopsy. This study aims to evaluate the sensitivity of endoscopic modalities including cholangioscopy-guided (miniature) biopsies ± brushings and/or fluoroscopy-guided biopsy (regular) biopsies for diagnosis of malignant biliary strictures in a real-world practice.

METHODS:

Endoscopy databases between 2015-2018 from two referral hospitals, one in USA and the other in Thailand, were retrospectively reviewed. Patients with indeterminate biliary stricture underwent ERCP and digital cholangioscopy-guided biopsy were included. Malignancy was confirmed by cytology or histology obtained by ERCP, surgery, or intervention-guided biopsy. Benign disease was confirmed by no disease progression and patient survived more than 6 months.

RESULTS:

A total of 58 patients (USA = 20 and Thailand = 38) with indeterminate biliary stricture underwent ERCP and cholangioscopy-guided biopsy were included. Forty-three patients had malignant strictures and 15 patients had benign strictures. The most common cause of malignant biliary stricture was cholangiocarcinoma (76.7%) and the most common cause of benign biliary stricture was IgG4-sclerosing cholangitis (46.7%). The majority of tissue acquisition was obtained by a combination of miniature biopsies + brushings + regular biopsies in 24 patients (41.4%) followed by a combination of miniature biopsies + regular biopsies in 20 patients (34.5%). Miniature biopsies alone was more frequently used in the USA site (30%) when compare with the Thailand site (5.3%). Sensitivity per methods of tissue acquisition were 12%, 48.8%, and 64.7% in brushings, miniature biopsies, and regular biopsies, respectively. Brushings had the lowest sensitivity in both centers (0% in USA and 18.8% in Thailand). Miniature biopsies had the highest sensitivity in the USA site (42.9%) and biopsy had the highest sensitivity in the Thailand site (65.4%). A combination of tissue acquisition methods provided the highest sensitivity, which was able to increase the sensitivity up to 10.5%.

CONCLUSION:

Cholangioscopy-guided biopsies are able to diagnose cancer in a half of patient who presented with indeterminate biliary stricture. Nevertheless, a combination of miniature biopsies with other tissue acquisition methods was more commonly utilized and had higher diagnostic yield than miniature biopsy alone.
875 Efficacy and Safety of Endoscopic Ultrasound (EUS) Guided Gastroenterostomy (GE): A Systematic Review and Meta-Analysis
Authors: Krishnamoorthi Rajesh , Jayaraj Mahendran , Gopalakrishnan Ravikumar Naveen Prasad , Singh Dhruv , Law Joanna , Larsen Michael , Ross Andrew , Kozarek Richard , Irani Shyan
Published: October 2019

INTRODUCTION:

Endoscopic ultrasound (EUS) guided gastroenterostomy (GE) is emerging as an alternative to enteral stenting and surgical GE for management of malignant gastric outlet obstruction (GOO). With advances in EUS technology and availability of dedicated devices/stents for EUS scopes, the use of EUS-GE is expected to increase in the future. We performed a systematic review and meta-analysis to estimate the success rate and adverse events associated with EUS-GE.

METHODS:

We conducted a comprehensive search of multiple electronic databases and conference proceedings including PubMed, EMBASE, and Web of Science databases (from inception through May 2019) to identify studies that reported success rate and adverse events of EUS-GE. The primary outcome was to estimate the pooled rates of technical and clinical success of EUS-GE. The secondary outcome was to estimate the rate of adverse events.

RESULTS:

9 studies with a total of 268 patients were included. The pooled rate of technical success of EUS-GE was 91.7 % (95% CI 87.5 – 94.5; I2 = 0). The pooled rate of clinical success of EUS-GJ was 87.8% (95% CI 83.1 – 91.3; I2 = 0). The pooled rate of overall adverse events was 12.6% (95% CI 9.0- 17.6; I2 = 0). The pooled rate of individual adverse events – perforation, bleeding, peritonitis and stent migration / misdeployment were 2% (95% CI 0.7 – 5.1), 3.2% (95% CI 1.5 – 6.5), 2.6% (95% CI 1.1-6.1) and 8.9 % (95% CI 4.3-17.5) respectively.The rate of surgical intervention for adverse events was 2%.

CONCLUSION:

While the rates of technical success (92%) and clinical success (88%) of EUS-GJ is promising, the risk of adverse events is considerable at 12.6%, with stent misdeployment (9%) being the most common adverse event. Hence, EUS-GJ should be performed at tertiary referral centers in a multidisciplinary (surgery, oncology, gastroenterology) team-based approach.
876 A Nationwide Landscape of Cardiopulmonary Complications Following Endoscopic Retrograde Cholangiopancreatography (ERCP)
Authors: Patel Harsh K. , Desai Rupak , Doshi Shreyans , Vyas Ankit , Vyas Manan , Goyal Hemant
Published: October 2019

INTRODUCTION:

Cardiopulmonary complications by and large account for higher endoscopic retrograde cholangiopancreatography (ERCP)–related complications in small-scale studies. However, the reported incidence remains quite low in large clinical studies due to lack of consensus definitions to report cardiopulmonary complications. We assessed the trends in age (18-44, 45-64, and ≥65 years), gender and race-specific cardiopulmonary complications and inpatient mortality using the largest inpatient cohort in the United States.

METHODS:

ERCP procedures (diagnostic and therapeutic) among adults and subsequent cardiopulmonary complications were identified using weighted data from the National Inpatient Sample (NIS) (2007-2014) and ICD-9-CM codes. Cardiopulmonary complications comprised of postoperative cardiac complications, periprocedural myocardial infarction, cardiac arrest including ventricular tachycardia/fibrillation/flutter, postprocedural hypotension, venous thromboembolism, hypoxemia, air embolism, and aspiration pneumonia. Trends in complications and mortality were analyzed using a linear-by-linear association in SPSS v.22 (IBM Corp, NY, USA). A two-tailed P ≤ 0.05 was considered clinically significant.

RESULTS:

In a total of 1,374,773 ERCP procedures (mean age 59 years; 60% males) performed during the 8-year study period, at least one cardiopulmonary complication was documented in 53,981 (3.9%) procedures. The highest rate was documented in patients aged ≥65 yrs (5.7%) with overall steady incidence rates throughout the study period (Figure 1). The overall mortality rate was significantly higher (8.5% vs. 1.2%, P < 0.001) among those who suffered any cardiopulmonary complication compared to those who did not. However, the inpatient mortality rates declined for both groups (from 9.1% to 7.1% and 1.4% to 1.1%, respectively) between 2007 and 2014 (Ptrend< 0.001) (Figure 2A). Males (4.8% vs. 3.4%) and white race group (4.2% vs. 3.7%) showed higher complications compared to females and another race groups, respectively (P < 0.001) (Figure 2B).

CONCLUSION:

This retrospective large cohort study revealed a 3.9% incidence rate of post-ERCP cardiopulmonary complications with an overall mortality rate of 8.5%. There was a steady trend in ERCP-related cardiopulmonary complications with a reassuringly declining trend in the inpatient mortality following cardiopulmonary complications. These findings warrant future studies and a goal of embracing preventive measures in a timely manner to curtail cardiopulmonary complications.
880 EUS-Guided Through-The-Needle Microforceps Biopsy Versus EUS-FNA in the Evaluation of Pancreas Cysts: A Meta-Analysis
Authors: Ponniah Sandeep A. , Westerveld Donevan , Draganov Peter V. , Yang Dennis
Published: October 2019

INTRODUCTION:

Accurate diagnosis and risk stratification of pancreas cysts (PCs) is crucial for management. A through-the-needle microforceps was recently introduced for endoscopic ultrasound (EUS)-guided tissue sampling of PCs. We performed a meta-analysis to evaluate the efficacy and safety of microforceps biopsy (TTNB) and compare its diagnostic outcomes with EUS-guided fine-needle aspiration (FNA).

METHODS:

Comprehensive search of electronic databases (PubMed, EMBASE, Cochrane, Web of Science) from inception to May 2019 to identify studies that reported on EUS-guided TTNB. Main outcomes included comparison of pooled rates of specific diagnosis and that of mucinous PCs with TTNB vs FNA. Secondary outcomes included concordance between TTNB, FNA with available surgical histopathology. Pooling was conducted using either fixed- or random-effects model depending on heterogeneity across studies.

RESULTS:

Seven studies including 365 patients were included. TTNB was technically feasible in 98% of the cases. A specific PC diagnosis was more frequently obtained with TTNB vs EUS-FNA (OR: 6.35; 95% CI: 4.47-9.01, I2 = 0). Similarly, diagnosis of a mucinous PC was most commonly obtained with TTNB vs. EUS-FNA (OR: 3.01; 95% CI: 1.32-6.86, I2 = 80%). Sixty-four of the 365 patients with PC underwent surgery. TTNB histology was concordant with a specific surgical histopathology in 81.9% (95% CI: 72.7-89.5; I2 = 12.1%) and with a diagnosis of a mucinous PC in 84.5% (95% CI: 70.4-94.6, I2 = 41.8%) of the cases. Using surgical histopathology as reference standard, the pooled diagnostic accuracy for histological severity of mucinous PCs was higher with TTNB vs. EUS-FNA (OR: 7.76; 95% CI: 1.21-49.9, I2 = 39%). The most common adverse event with TTNB was self-limited intracystic bleed (4.3%), followed by acute pancreatitis (1.9%) and abdominal pain (1%).

CONCLUSION:

This meta-analysis demonstrates that in the evaluation of PCs, TTNB procures a specific diagnosis and identifies a higher proportion of mucinous PCs when compared to EUS-FNA. TTNB histology is highly concordant with surgical histopathology and was more accurate in grading mucinous PCs histological severity when compared to EUS-FNA. Future comparative randomized trials are needed to corroborate these findings.
888 Percutaneous Gastrojejunostomy Tubing Utilization and Safety With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson’s Disease Patients: Interim Results of the Long-Term DUOGLOBE "Real-World" Observational Study
Authors: Draganov Peter V. , Wilcox Charles M. , Lee Michelle , Robieson Weining Z. , Kukreja Pavnit , Bergmann Lars , Peter Shajan , Symington Kenneth E.
Published: October 2019

INTRODUCTION:

Levodopa-carbidopa intestinal gel (LCIG, carbidopa-levodopa enteral suspension [CLES] in the US) administered via percutaneous gastrojejunostomy (PEG), a jejunal (J) extension tube and an external pump is a long-term treatment option for patients with advanced Parkinson’s disease (aPD). Limited data exists on PEG-J component utilization and replacements during LCIG treatment in a ‘real-world’ setting. This interim analysis investigated the routine clinical practice of PEG-J insertion and component replacements of the device and associated safety.

METHODS:

DUOGLOBE is an ongoing multinational observational study with 3-year follow-up. This interim analysis included patients who had the PEG-J insertion procedure from 55 global sites. The type of tubing used, frequency of and reasons for tube replacements, and Serious Adverse Events (SAEs) were assessed. This analysis was not powered for statistical comparisons.

RESULTS:

This interim dataset had 188 patients with PEG-J tube placement (mean duration of PEG-J exposure: 515.8 days); 178 patients with PEG-J tubing manufacturer data were included in this analysis. At initial PEG-J tube placement, 83% (n = 148) of patients received AbbVie-proprietary tubing and 17% (n = 30) received non-AbbVie tubing. Most patients 79% (n = 141) did not require a PEG-J replacement. Patients needing any PEG-J replacement was similar between AbbVie and non-AbbVie tubing (22% and 17%); 5% of patients (n/N = 7/148) with AbbVie tubing required 2 PEG-J replacements (n/N = 0/30 for non-AbbVie tubing). In the first 12 months, Kaplan-Meier estimates demonstrated that 84% of patients did not require a tube replacement with AbbVie tubing (non-AbbVie tubing, 89%). The most common reasons for the first PEG-J replacement for AbbVie tubing was a routine, preplanned procedure (6%), PEG-J dislocation (4%), occlusion and leaking (each 2%), and other (5%); for non-AbbVie tubing PEG-J dislocation (10%) was the only reported reason. Overall, 38% of patients experienced an SAE who had AbbVie tubing (n = 56) and 47% for non-AbbVie tubing (n = 14). Gastrointestinal (GI)-related SAEs were reported in patients [n(%)] with AbbVie tubing [8(5%)] and non-AbbVie tubing [6(20%)]; 1 (1%) and 2 (7%) patients discontinued due to a GI-related AE, respectively.

CONCLUSION:

This interim analysis of patients in a multinational observational study with LCIG demonstrated that most patients did not require PEG-J tube replacements in a real-world setting and safety was similar to the known safety profile of LCIG.
890 The Impact of Multidisciplinary Evaluation Before and After Endoscopic Sleeve Gastroplasty on Weight Loss and Quality of Life
Authors: Boškoski Ivo , Bove Vincenzo , Laterza Lucrezia , Gallo Camilla , Landi Rosario , Familiari Pietro , Tringali Andrea , Perri Vincenzo , Attili Fabia , Costamagna Guido
Published: October 2019

INTRODUCTION:

Endoscopic sleeve gastroplasty (ESG) is a relatively novel endoscopic procedure that reduces the gastric lumen with proven less complications and almost same 6 months weight loss compared to laparoscopic sleeve gastroplasty (LSG). To our knowledge there are no trials investigating the role of multidisciplinary evaluation (ME) before and after ESG. The aims of the present study were to evaluate the role of ME prior and after ESG in terms of weight loss outcomes, quality of live improvements and adverse events.

METHODS:

From May 2016 to April 2019 all patients that underwent ESG were retrospectively evaluated from a prospective database. Included patients had 2° and 3° degree of obesity or 1° with comorbidities. All patients underwent upper GI endoscopy to exclude pathologies. Until September 2017 before ESG only psychiatric evaluation was requested (group 1), while after this date we adopted the guidelines of the Italian Society for Obesity Surgery and all patients were evaluated on a multidisciplinary team composed by gastroenterologist, surgeon, psychiatrist, endocrinologist and dietitian (group 2). We compared this two groups in terms of Excess Weight Loss (%EWL), Total Body Weight Loss (%TBWL) and quality of life improvements, measured with the Bariatric Analysis and Reporting Outcome System (BAROS). ESG was done with the Apollo Overstitch suturing system (Apollo Endosurgery) and a double channel gastroscope Olympus 2TGIF-160 (Olympus Japan) in general anesthesia and with insufflation of CO2. All patients had ambulatory visit t 1, 3, 6 and 12 months after ESG. Statistical analysis was done with chi-square test and < 0.05 value was considered significant. The study was approved by the local Ethical Committee (N° 19211/18).

RESULTS:

A totally of 89 ESG were performed. Group 1 consisted of 11 patients while Group 2 of 78. Mean procedure time was 51 minutes (range 28-92). Mean number of stitches were 4.7/patient (range 3-8). No procedure related complications were observed. Female were 56 patients; mean age was 45.4 (range 23-73). Mean BMI at inclusion was 41.6 (range 31.6-62.4). Mean %EWL and %TBWL at 12 months was 37.6 and 15.6 respectively (Table 1). Comparing the two groups there was significant (P < 0.05) difference in terms of %EWL, %TBWL and BAROS scale (Table 2) for all periods of follow-up, with better results in group 2.

CONCLUSION:

ME before and after ESG has a fundamental role in terms of better procedure outcomes for both weight loss and quality of live in obese patients.
891 Efficacy and Safety of Per-Oral Cholangioscopy With Lithotripsy for Difficult Biliary Stones: A Cumulative Systematic Review and Meta-Analysis
Authors: McCarty Thomas R. , Gulati Rishabh , Rustagi Tarun
Published: October 2019

INTRODUCTION:

Per-oral cholangioscopy with intraductal electrohydraulic lithotripsy (EHL) or laser lithotripsy facilitates optically-guided biliary stone fragmentation in cases refractory to conventional endoscopic therapy. The primary aim of this study was to evaluate the efficacy and safety of per-oral cholangioscopy with intraductal lithotripsy for difficult biliary stones.

METHODS:

Searches of PubMed, EMBASE, Web of Science, and Cochrane Library databases were performed in accordance with PRISMA and MOOSE guidelines. Measured outcomes included overall fragmentation success, single session fragmentation and duct clearance rate, and rate of adverse events. Sensitivity and subgroup analysis was performed based upon cholangioscopy technique and type of lithotripsy. Pooled rates were estimated using random effects modelswith 95% prediction interval calculated to simulate clinical practice. Heterogeneity was assessed with Cochran Q test and I
2 statistics. Publication bias was ascertained by funnel plot and Egger regression testing.

RESULTS:

Thirty-two studies (n = 1513; 43.87% male) were included. Mean age was 60.87 ± 11.83 years. Prior cholecystectomy occurred in 23% of patients with an average number of 1.56 ± 0.49 prior ERCPs performed. Mean stone size was 2.15 ± 2.8 cm. Per-oral cholangioscopy with intraductal lithotripsy achieved an overall stone fragmentation successof 91.29% (95% CI 87.78 to 93.86) with an average of 1.35 ± 0.67 lithotripsy sessions performed. Mean procedure time was 68.32 ± 20.99 minutes. Complete fragmentation success and duct clearance with a single lithotripsy session was 75.71% (95% CI 69.69 to 80.86). Rate of adverse events was 9.72% (95% CI 6.98 to 13.38). Cumulative and sensitivity analyses limited to prospective and randomized controlled trials as well as studies limited to the second generation, digital cholangioscope device are shown in Table 1. Subgroup analyses based upon EHL versus laser lithotripsy demonstrated laser therapy to be more effective – though this was not statistically significant [overall fragmentation 90.14% versus 91.79%, P = 0.384; single session success rate 70.47% versus 82.10%, P = 0.058; and adverse event rate 11.85% versus 11.30%, P = 0.810] – Table 2.

CONCLUSION:

Per-oral cholangioscopy with intraductal lithotripsy appears to be a relatively safe and highly effective modality for difficult biliary stones. Laser lithotripsy outperformed EHL treatment; however, this difference was not statistically significant.
892 A Retrospective Study of the Influencing Factors on Fluoroscopy Time (FT) and Patient Radiation Dose (DAP) During ERCP in a Setting of 12 Large Tertiary Academic Hospitals
Authors: Patil Prithvi , Subramanian Sruthi K. , Ramireddy Srinivas , Badillo Ricardo , Davee Tomas , Thosani Nirav
Published: October 2019

INTRODUCTION:

ERCP uses endoscopic and radiological guidance to accomplish diagnosis and therapy of biliary and pancreatic disorders. During ERCP, the patients are exposed to a higher amount of radiation dose compared to endoscopy staff and over the years both the number and the complexity of the procedure associated has increased significantly resulting in longer procedural and fluoroscopy times. This increasing exposure of patients to such medical radiation is concerning. The primary aim of this study was to get familiar and better understand the various factors influencing patient radiation dose to be able to optimize radiation exposure in fluoroscopy procedures, thereby, minimizing the risk of any radiation-induced injury.

METHODS:

Retrospective analysis of a prospectively collected database over a study period of 3.5 years (January 2015 to May 2018) was performed. Data related to patient demographics, ERCP indication and radiation exposure in ERCP procedures (n = 7400) in a setting of 12 large tertiary academic hospitals was reviewed and analyzed. Statistical significance, increased Fluoroscopy Time (FT) and Dose area product (DAP) were identified. All ERCPs were graded on their procedural complexity with scores from 1 to 4 signifying simple to the most complex ERCPs.

RESULTS:

Factors independently associated with an increased FT and DAP included age, level of complexity and the volume of the hospitals performing ERCPs (High volume hospital – more than 450 ERCPs a year). The average Fluoroscopy time (FT) and DAP for different ages (Patients under 35 years old, 35-65 years old and over 65 years old). The average FT was 45.8% higher in patients with higher complexity score and also had a higher DAP of about 13.5%. Also, ERCPs performed in a lower volume hospital had a higher FT (2.93 vs 2.78) and a higher dose area product (12.5 vs 10.1) compared to the higher volume hospitals.

CONCLUSION:

A number of factors were found to affect the FT and DAP in ERCP. The awareness about the risks of radiation exposure to patients, specific settings of the fluoroscopy machine used and various fluoroscopy modifications that can decrease radiation exposure will help to predict prolonged procedures thereby facilitating the use of appropriate precautions.
894 Ulcer Formation in Patients With GAVE and Gastric AVMs After Endoscopic Ablation
Authors: Stratton Leland , Henry Zachary , Wynter Javelle , Reutemann Bethany , Shah Neeral
Published: October 2019

INTRODUCTION:

Gastric antral vascular ectasia (GAVE) is a cause of chronic gastrointestinal bleeding and is often managed with upper endoscopic ablation. At our institution, ablation for GAVE or other gastric arterio-venous malformation (AVM) is carried out using either argon plasma coagulation (APC) or bipolar electrocautery. No prior study exists comparing the safety profiles of these two modalities. The aim of this study was to determine the rate of ulcer development following ablation therapy for GAVE or gastric AVM and compare the rate of ulcer formation in patients treated by APC versus electrocautery.

METHODS:

Retrospective chart review of patients who underwent endoscopic ablation of GAVE or gastric AVM with subsequent upper endoscopy between 2007-2017. The primary outcome was presence of ulcers on follow up endoscopy in the region previously ablated. Sub-group analysis of demographics, comorbidities, prescriptions and laboratory data at time of therapy was also completed to determine other risk factors. Statistical analysis of ulcer rates between groups were compared using the Chi-square model.

RESULTS:

Of the 139 patients treated for bleeding GAVE or gastric AVM, 81 (58%) received APC and 58 (42%) bipolar electrocautery. In total, 26 (19%) patients were noted to have ulcer on follow-up endoscopy. Eighteen (22%) of patients treated with APC developed ulcers compared to eight (14%) with electrocautery (P = 0.2). There were no significant differences in co-morbidities, medications or age between the groups. Notably, 76 (55%) patients had cirrhosis, of whom 16 (21%) developed ulcer compared with 10 (16%) patients without cirrhosis (P = 0.44). Among cirrhotic patients there was no significant difference in ulcer rates between APC and electrocautery (P = 0.7).

CONCLUSION:

Ulcer development after endoscopic ablation for treatment of GAVE or gastric AVM is not uncommon, occurring in 19% of patients. Difference in ulcer rates between APC and electrocautery was not statistically significant, indicating that the two endoscopic modalities carry equal risk of ulcer formation. Of the demographic, diagnostic, medication and lab variables analyzed, none were found to significantly increase risk of ulcer development. Only cirrhosis and thrombocytopenia, which are inherently coupled, showed any trend towards significance. We propose that APC and electrocautery are equally safe and may be employed to treat bleeding from GAVE or gastric AVM.
895 Comparison of Endosonographic Pancreatic Abnormalities Between Diabetics and High Risk Individuals for PDAC
Authors: Schwartz Ingrid , Vankawala Preksha , Satiya Jinendra
Published: October 2019

INTRODUCTION:

Several predisposing factors for pancreatic ductal adenocarcinoma (PDAC) have been described. High risk individuals (HRIs) are defined by presence of significant family history (FH) or predisposing genetic mutations/syndromes. Studies have postulated that Diabetes Mellitus (DM) could also play a role in PDAC; however, this relationship is not yet fully elucidated. We aimed to identify the prevalence and distribution of pancreatic parenchymal and ductal changes during EUS of DM patients compared to HRIs.

METHODS:

We retrospectively reviewed EUS findings of patients with DM or with a significant FH of PDAC and/or a predisposing high-risk genetic mutation/syndrome (BRCA2, PALB2, CDKN2A, ATM, Lynch and Peutz-Jeghers Syndrome). Significant FH was defined as (1): 2 or more relatives with PDAC, including at least one first-degree relative (FDR); (2) 3 or more non-FDR with PDAC.

RESULTS:

100 patients were included: 78 in diabetes and 22 in HRI group (12 = significant FH, 7 = high-risk genetic mutations, 3 = Lynch Syndrome). Patient demographics are presented in Table 1. The mean number of EUS procedures was 1.25 ± 0.62 and mean interval between procedures was 299.3 ± 299 days. Pancreatic abnormalities on EUS were found in 47% of patients (Table 2). In HRI group, cysts was the commonest finding (9), out of which 7 had significant FH for PDAC. Cysts were consistent with Intraductal Papillary Mucinous Neoplasm (IPMN) in 8 patients. Pancreatic mass was evidenced in 3 cases, out of which 1 was found to be malignant. In DM group, the most frequent finding was lobularity (20), followed by main pancreatic duct (PD) dilation (8). Cysts were present in 4, with 1 malignant outcome. Mass was present in 4, with 2 diagnosed as PDAC and one as neuroendocrine tumor. When defined using the Rosemont classification, 3 patients had findings consistent with chronic pancreatitis, 2 in the DM group and 1 in the HRIs group. In the HRIs group, 8 patients underwent interval EUS, and new/additional pancreatic abnormality was seen in 1 patient. Nine patients in the DM group underwent interval EUS and 1 patient showed progression of changes.

CONCLUSION:

There is a clear difference in the most prevalent endosonographic findings in DM and HRI patient groups. Whereas cysts appear to be more prevalent in HRI for PDAC, diabetics have higher prevalence of lobularity on EUS examination. When available, repeat EUS examination demonstrated stable findings in almost all cases.