bluuebunny/crossref_metadata_2025 huggingface dataset:
1200 Rifabutin (RHB-105) Based Triple Therapy for Helicobacter pylori (HP) Infection Eradication: Results of Pivotal Phase 3 Multi-Center Study (ERADICATE Hp2)
Authors: Graham David Y. , Canaan Yamil , Maher James , Weiner Gregory , Kalfus Ira N.
Published: October 2019

INTRODUCTION:

H. pylori causes considerable morbidity and mortality worldwide, and antimicrobial resistance has led to unacceptably low eradication rates for previously effective therapies. The WHO has categorized H. pylori as a pathogen for “High Priority” therapeutic development. A prior clinical study (NCT01980095) of RHB-105 showed an eradication rate of 89.4% in the mITT (received at least 1 dose of therapy and post treatment test of cure) population.

METHODS:

Phase 3, double-blind, active comparator study (NCT03198507) assessed HP eradication with 4 capsules RHB-105 (an ‘all-in-one’ fixed dose oral capsule providing rifabutin 50 mg, amoxicillin 1000 mg, omeprazole 40 mg) vs high dose PPI-amoxicillin dual therapy (amoxicillin 1000 mg, omeprazole 40 mg) Q8H for 14 days.Dyspeptic, treatment naïve subjects with confirmed HP infection, 13C UBT (urea breath test) and endoscopy (CLO test, pathology, or culture), had 13C UBT primary end point assessed at least 4 weeks post-therapy. Subjects who failed HP eradication were assessed for development of resistance and offered physician-directed standard of care.

RESULTS:

In 455 subjects randomized 1:1, the ITT eradication rate of RHB-105 (83.8%) was superior to that of active comparator (57.7%), P < 0.0001. A pre-specified PK population assessing efficacy in subjects with positive drug levels at day 13 similarly demonstrated superiority of RHB-105 over active comparator 90.3% vs. 64.7%, P < 0.0001. No rifabutin resistance was noted pre or post treatment. RHB-105 efficacy was unaffected by clarithromycin or metronidazole resistance. Drug compliance was similar in both groups (>95%). Comparable AEs were noted between arms with no drug related SAEs reported. AEs seen with RHB-105 (>1% over comparator) were diarrhea (10.1% vs 7.9%) and rash (1.3% vs 0.0%). Physician directed standard of care (primarily clarithromycin or metronidazole based) eradication rate was 53% in patients who failed double blinded therapy.

CONCLUSION/DISCUSSION:

RHB-105, an all-in-one rifabutin triple therapy, was safe, effective, well-tolerated in H. pylori eradication, and not affected by clarithromycin or metronidazole resistance. The efficacy for RHB-105 was substantially greater due to rifabutin and the difference was statistically significant and clinically meaningful. RHB-105 may be a new best in class, first line empiric treatment for H. pylori infection, with the potential to serve an unmet need in an environment of increasing antibiotic resistance.
1212 H. pylori Breath Testing in an Academic Medical Center: Utilization and Treatment Outcomes
Authors: Monk Ian , Benjaram Sindhuri , Sahni Neha , Naylor Paul , May Elizabeth , Ehrinpreis Murray N.
Published: October 2019

INTRODUCTION:

Helicobacter pylori is a major cause of stomach and duodenal ulcers According to the 2017 American College of Gastroenterology (ACG) Clinical Guidelines, only patients with active or past Peptic Ulcer Disease (PUD), low-grade MALT lymphoma, or history of endoscopically resected early gastric cancer should be tested for H. pyloriinfection. The breath test should be performed at least 4 weeks after stopping antibiotics and at least 2 weeks after stopping PPIs. The objective of this study was to determine whether the guidelines for the use of the breath test in an internal medicine physician practice were being followed.

METHODS:

We evaluated all 2016 patients in an academic Internal Medicine practice who had a BreathTek® Urea Breath Test for H. pylori in 2016. Patient files were reviewed through 2018 with respect to treatment and outcomes.

RESULTS:

An H. pylori breath test was performed in 257 patients (191 African-American (AA); 74%) and 66 non-AA). It was most likely used for diagnostic purposes (217/257 = 84%) and more likely to be ordered by a non-gastroenterologist (non-GI) (94% vs 69%; P < 0.001). Only 2 tests were for PUD; the majority were for Acid Reflux/Dyspepsia/GERD (48%), Abdominal Discomfort (33%), or Nausea/Vomiting/Recurrence of symptoms (12%). Of the 68 patients on a PPI, the gastroenterologists (GI) were more likely to comply with the guidelines of waiting to perform the test 2 weeks later as compared to the non-GI (48% vs 23%; P < 0.05). Of the 84 patients who were positive for H. pylori and were treated, 55 were cured with treatment, 22 were lost to follow up, and 7 were not cured with treatment (89% cure per protocol). The primary treatment was triple therapy (n = 77) with Clarithromycin/Amoxicillin (Metronidazole)/PPI. Seven patients were treated with quadruple therapy (triple plus bismuth). The percent of cured patients was similar between AA (87%) and non-AA (95%). Retreatment was successful in the 3 patients who received it.

CONCLUSION:

The majority of breath tests were for gastric/esophageal discomfort and did not meet the recommended criteria for the test. Significant numbers of providers in this study did not wait the recommended 2 weeks following PPI usage when ordering a breath test for H. pylori. Patients responded well to treatment with antibiotic and PPI therapy regardless of race. Thus, these studies suggest that educational interventions might be useful to increase compliance with the guidelines.
1214 Quadruple Therapy Is Superior to Triple Therapy in the Treatment of Clarithromycin Exposed Helicobacter pylori
Authors: Ramai Daryl , Aamar Ali , Goldstein Robyn , Solow Marissa , Madedor Ogenetaga , Tsipotis Evangelos , Reddy Madhavi
Published: October 2019

INTRODUCTION:

Resistance of Helicobacter Pylori to antibiotics has reached alarming levels around the world, which has a great effect on efficacy of treatment. Little is known about its resistance pattern and optimal treatment within Brooklyn, New York. The objective of this study was to investigate whether triple or quadruple therapy is more effective in the treatment of H. Pylori, and whether prior clarithromycin exposure affects primary clinical outcomes.

METHODS:

A total of 598 patients were identified by retrospective chart review from January 2015 to January 2018 that satisfied our inclusion criteria; 272 of those patients were selected based on selection criteria. Patients were excluded from the study if they were less than 18 years of age, or were treated for recurrent H. Pylori infection. Descriptive statistics was used to compare continuous and categorical variables.

RESULTS:

Of the 272 patients identified, the median age was 50 ± 16 years. The majority (36%) of patients were Asian. Approximately 20.5% of patients were active smokers or had a history of smoking. 84% (n = 229) patients did not have prior clarithromycin exposure, while only 16% (n = 43) were exposed. 65% (n = 176) patients used triple therapy, while 35% (n = 96) used quadruple therapy for H. Pylori treatment. 79% (n = 214) patients had no recurrence, while 21% (n = 58) patients experienced treatment failure. Overall, triple therapy was associated with higher rates of treatment failure when compared to quadruple therapy (22% triple therapy vs 20% quadruple therapy). When prior clarithromycin exposure taken into account, treatment failure increased to about 28%. This effect was higher in patients treated with triple therapy than quadruple (28% vs 27%, respectively). However, due to small sample sizes, significance was not observed.

CONCLUSION:

Quadruple therapy appears to be more effective at treating H. Pylori overall and in the setting of prior clarithromycin exposure. While these findings may guide clinical decision making, larger head to head studies are needed to validate these findings.
1218 The Relationship Between Gastric Food Residue and the Rate of Gastric Emptying
Authors: Bi Danse , Camilleri Michael , Prichard David O. , League John
Published: October 2019

INTRODUCTION:

Gastric food residue (GFR) identified during gastrointestinal (GI) endoscopy is assumed to reflect delayed gastric emptying (GE [i.e., gastroparesis]). The aims of this study aims were to determine i) the prevalence of GFR during upper GI endoscopy (EGD) and, ii) the relationship between GFR and GE, structural abnormalities and diseases associated with gastroparesis.

METHODS:

Electronic health records were used to identify patients who had undergone both EGD and gastric emptying scintigraphy (GES) between October 2013 and September 2018. The test meal included radiolabeled scrambled eggs (320 kcal, 30% fat). Data were collected via the Advanced Cohort Explorer (ACE) application available at Mayo Clinic. The presence of GFR, structural or physiological factors associated with delayed GE was determined. Descriptive and comparative analyses were performed.

RESULTS:

In the 5 year period, the prevalence of GFR during upper GI endoscopy was 3.2% per patient and 2.5% per procedure (37% or patients had undergone >1 procedure). Of 3169 patients who underwent both EGD and GES available for review, 230 (7.3%) had GFR. Type 1 diabetes mellitus (DM, 22% vs 7%, P < 0.001) and type 2 DM (13% vs 7%, P < 0.05), but not systemic sclerosis (P = 0.1), were associated with GFR. Relative to patients with no GFR, patients with GFR had reduced GE at 2 and 4 hours (35% vs 46%, P < 0.001 and 67% vs 81%, P < 0.001 respectively) and were more likely to have structural abnormalities in the stomach or small bowel (e.g., surgery/stenosis, 14% GFR vs. 5%, P < 0.001) or have predisposing medical conditions (e.g. DM, systemic sclerosis, 20% GFR vs. 8%, P < 0.001). GE rates for patients with these conditions are shown in Table 1. Among those with no structural abnormalities or medical conditions associated with delayed GE, GE at 2 hours and 4 hours was significantly reduced in patient with GFR compared to those without GFR (37% vs 46%, and 69% vs 81%, both P < 0.001 respectively). The proportion of patients with delayed GE at 2 and 4 hours was greater in patients with GFR than without (42% vs 22% and 35% vs. 54%, both P < 0.001).

CONCLUSION:

GFR is encountered in 3% of all EGDs. In a cohort undergoing endoscopy and GES, ∼20% of patients with type 1 DM demonstrated GFR. The presence of GFR during endoscopy is associated with retarded GE. However, almost 50% of patients with GFR will have normal GE; therefore the presence of GFR at EGD does not accurately reflect gastric retention of digestible solids.
1219 Usefulness of Blood Flow Rate of Subepithelial Microvessels in Gastric Mucosa Using Magnifying Endoscopy in the Stomach
Authors: Ueyama Hiroya , Matsumoto Kenshi , Murakami Takashi , Yao Takashi , Nagahara Akihito
Published: October 2019

INTRODUCTION:

Magnifying endoscopy simple diagnostic algorithm for early gastric cancer (MESDA-G) is used for qualitative diagnosis based on irregular microvascular architecture and micro-surface structure, but it is a static diagnostic algorithm using still images. On the other hand, magnifying endoscopy (ME) visualizes subepithelial microvascular red blood cell (RBC) flow in real time, but there has been no study focusing on the usefulness of microvascular blood flow in the diagnosis of early gastric cancer. We therefore evaluated microvascular blood flow using ME in the diagnosis of early gastric cancer.

METHODS:

Patients with early gastric cancer (EGC, n = 5) or patchy redness (PR, n = 5) underwent ME with blue light imaging (M-BLI, EG-L600ZW7, Fujifilm) at our hospital. A scale in 1-mm increments was visualized at 100× (3 frames) to 135× (4 frames) magnifications prior to examination, and gastric subepithelial microvascular blood flow in lesions and background mucosa videoed using M-BLI. Images were split into 30 frames/sec, and the mean blood flow rate was calculated by the mean movement distance of one tagging RBC. The blood flow rates in EGC, PR and background mucosa were compared between them. The ratio of blood flow rate (inside lesion/background mucosa) was compared between EGC and PR.

RESULTS:

EGC characteristics were as follows: mean age, 74.6 ± 7.8 years; male/female ratio, 2:3; previous history (hypertension: 1); Helicobacter pylori infection (current: 3, eradicated: 2); location (M: 4, L: 1); macroscopic type (IIa: 3, IIc: 2); histology (well- [n = 4] and moderately differentiated [n = 1] adenocarcinoma); and invasion depth (all M). PR characteristics were as follows: mean age, 68.2 ± 10 years; male/female ratio, 4:1; previous history (hypertension: 3); H. pylori infection (eradicated: 5); location (M: 2, L: 4). The mean blood flow rate was significantly slower in EGC (1881.4 μm/s; range 1406–2344) vs. PR (4162.6 μm/s; 3281–4688) or background mucosa (4265.7 μm/s; 3750–5156) (P < 0.01). The ratio of blood flow rate (inside lesion/background mucosa) was significantly lower in EGC (0.46; 0.38–0.50) than in PR (0.94; 0.88–1.10; P < 0.01).

CONCLUSION:

Early gastric cancer was associated with a significantly slower gastric subepithelial microvascular flow rate compared to patchy redness and background mucosa. Gastric subepithelial microvascular flow using magnifying endoscopy in real time may enable physiological diagnosis of early gastric cancer.
1226 Under-Utilization of Proton Pump Inhibitors in the Prevention of NSAID-Related Peptic Ulcer Disease in the Elderly
Authors: Al-Taee Ahmad M. , Ghoulam Elie , Lee Preston , Sbertoli Robert , Hachem Christine
Published: October 2019

INTRODUCTION:

Peptic ulcer disease (PUD) develops in approximately 25% of chronic users of non-steroidal anti-inflammatory drugs (NSAIDs). The incidence of uncomplicated PUD has been declining over the past 3 decades unlike that of complicated PUD especially in the elderly. We aimed to evaluate physician compliance with the American College of Gastroenterology (ACG) guidelines on the prevention of NSAID-related PUD complications in a tertiary academic setting.

METHODS:

We examined the Saint Louis University Hospital medical record database for a 9-month period extending from April 2018 until December 2018. Using this database, we identified 2,064 adult elderly patients (>64 years old) who were chronic (>3 months) users of low dose aspirin (81 mg once daily). We performed a retrospective analysis of patients who were at least on aspirin and had an indication for PUD prophylaxis as per ACG guidelines. Data collected from patient charts included age, gender, relevant medications (including proton pump inhibitors (PPI), aspirin, P2Y12 inhibitors, direct oral anticoagulants (DOACs), warfarin, or oral steroids), and whether prophylaxis was provided as per the ACG guidelines.

RESULTS:

A total of 301 adult elderly patients who were at least on aspirin and had an indication for PUD prophylaxis were identified in this study. The mean age was 75 years old. Six percent of included patients had a history of peptic ulcer disease. In addition to aspirin, patients were using P2Y12 inhibitors (clopidogrel or ticagrelor, 50%), DOACs (24%), warfarin (11%), or steroids (9%). DOAC users were prescribed apixaban (16%), rivaroxaban (7%), or dabigatran (1%) (Table 1). All antiplatelets, anticoagulants, and steroids were prescribed by non-gastroenterologists. Only 35% of patients with an indication for PUD prophylaxis received a PPI. The prophylaxis rates were highest for patients with a history of peptic ulcer disease (62%) and were lowest for users of P2Y12 inhibitors (29%). There were no statistically significant age or gender related differences in the rates of compliance when independent sample t and chi square tests were performed (Table 1).

CONCLUSION:

Peptic ulcer disease prophylaxis with proton pump inhibitors may be underutilized in elderly patients. This finding, along with increasing rates of NSAID use and aging population, may help explain the increased incidence of complicated PUD in the elderly. Efforts are needed to raise physician awareness of PUD prophylaxis guidelines.
1232 Factors Associated With Treatment Failure in Biopsy Proven Helicobacter pylori Infection in the Rio Grande Valley: A Retrospective Review of 3 Years Data
Authors: Castano Juan J. , Rapoport Grigoriy , Rivera Arturo Suplee , Sraow Amrit , Garrison Keith , Lopez-Alvarenga Juan C. , Chacon Ingrid
Published: October 2019

INTRODUCTION:

The 2017 American College of Gastroenterology Clinical guidelines advocate clarithromycin triple therapy (CTT) as first line H. Pylori (HP) treatment. CTT consists of a 14-day course of a proton pump inhibitor (PPI), clarithromycin, and amoxicillin or metronidazole. The national CTT eradication rate (ER) nears 80%. Many well-established factors affect treatment success including therapy duration, compliance, smoking, diabetes mellitus (DM), and local antibiotic resistance rates. Efficacy data on CTT in the Rio Grande Valley (RGV) has not been previously described. It is assumed that local resistance rates parallel those of our neighboring country due to proximity which may influence clinical practice. Aim is to determine the factors that affect biopsy-proven HP treatment failure.

METHODS:

A retrospective analysis of patients treated for HP in one RGV gastroenterology center between 2015 and 2018 was done. Eradication was defined by either a negative 13C Urea breath test or by a negative HP stool antigen test after treatment. ER was calculated for each regimen and compared against therapy duration, smoking, DM, health insurance status, and socioeconomic level; the latter determined by patient zip codes. We calculated raw ORs (95% CI) and adjusted with Cox and binary logistic regression.

RESULTS:

Of 544 patients, 71% (384) were females and 97% (526) were Hispanic. Nonsmokers were 79% (425) and diabetics were 32% (174). In total, 56% (305) received CTT and 44% (239) received quadruple therapy (QT) (ie., Tetracycline, metronidazole, bismuth, any PPI). ER was 66% for CTT and 62% for QT. Regarding both therapies, no treatment failure difference was found (P = 0.62) at 10 days, however, treatment failure decreased with 14-day therapy (P < 0.001). Regarding health insurance, 84% (452) had private, 13% (72) had government-issued, and 3% (16) were self-pay. Cox regression found no differences in treatment type. Logistic regression found that females OR 2.25 (95% CI 1.4, 3.5, P < 0.001), income <$40,000/year OR 1.78 (95% CI: 1.1, 2.8, P = 0.013), and smoking OR 1.6 (95% CI 1.03, 2.6, P = 0.034) negatively affected eradication.

CONCLUSION:

HP therapy efficacy was suboptimal, however, 14-day therapy improved treatment failure. More females were affected with HP. Factors negatively affecting eradication were female gender, smoking, and income <$40,000/year. Further studies are required to determine the role of patient education, HP local antibiotic resistance patterns, and physician practice on HP eradication.
1235 Risk Factors for Advanced Gastric Intestinal Metaplasia in a Multi-Ethnic United States Cohort
Authors: Huang Robert , Park Sungho , Chitre Tanvi , Shen Jeanne , Longacre Teri , Hwang Joo Ha
Published: October 2019

INTRODUCTION:

Gastric intestinal metaplasia (GIM) is a precursor to gastric cancer (GC). The operative link for GIM (OLGIM) is a standardized histologic scoring system (ranging 0 to 4) used to evaluate severity of GIM; in prospective European studies, it has been shown to predict risk for progression onto GC. Use of OLGIM has not previously been described in North American populations. Risk factors for advanced GIM are poorly described in North America, and currently no screening recommendations exist for either GC or GIM.

METHODS:

We prospective enrolled patients between the ages of 30 and 84 scheduled to undergo outpatient endoscopy at Stanford University for the following indications 1) dyspepsia, 2) H. pylori assessment, 3) GC screening, or 4) GIM surveillance. At time of enrollment, all patients completed a standardized questionnaire inquiring about medical, family, dietary, and exposure history. Biopsies were performed from both antrum and body. Histologic scoring was performed according to a Standardized protocol, and OLGIM score assigned to each subject. We compared demographic, clinical, and environmental variables between subjects with GIM and subjects without GIM. We also compared subjects with advanced GIM (defined as OLGIM ≥ 2) with subjects without advanced GIM (OLGIM < 2). Continuous variables were analyzed using Student's T-test, and categorical variables were analyzed using the Chi-squared test.

RESULTS:

38 subjects with GIM, and 41 subjects without GIM were enrolled. Of the GIM group, 20 subjects demonstrated advanced GIM. Subjects with GIM were older (P = 0.001), more likely to have a history of H. pylori treatment (P = 0.002), and more likely to be first-generation immigrants (P = 0.008) compared to subjects without GIM (Figure 1). Subjects with advanced GIM were more likely to be older (P = 0.02), and more likely to be first-generation immigrants (P = 0.04) compared to subjects without advanced GIM (Figure 2). Gender, presence of symptoms, presence of medical comorbidity, family history, smoking status, and dietary preferences did not demonstrate significant differences between groups in this cohort.

CONCLUSION:

Age and immigration status, known risk factors for GC, may also be risk factors for advanced GIM. As advanced GIM significantly increases risk for GC, detection of advanced GIM may improve GC morbidity and mortality. Additional research should be focused on non-invasive testing to detect advanced GIM in North American populations.
1236 Hospitals With Low-Medium Safety-Net Burden Incur the Highest Costs for Hospitalizations of U.S. Adults With Gastric Cancer
Authors: Park Gavin , Hirode Grishma , Wong Robert
Published: October 2019

INTRODUCTION:

Although gastric cancer is relatively rare in the U.S., diagnosis at an earlier stage is associated with improved treatment options and higher overall survival. Safety-net hospitals continue to bear the brunt of recent major healthcare coverage reforms. We aim to evaluate factors, including safety-net burden (SNB), associated with in-hospital mortality and inpatient costs among hospitalized adults with gastric cancer.

METHODS:

Using the 2012-2014 National Inpatient Sample, adult hospitalizations with gastric cancer were identified using ICD-9 codes. Hospital SNB was defined as percentage of hospitalizations with Medicaid or uninsured payer status per hospital, and categorized into three groups: none, low-medium, and high. Between-group comparisons used chi-squared testing. Adjusted logistic regression was used to analyze predictors of in-hospital mortality. Multivariate linear regression was performed after logarithmic transformation of the outcome to identify factors associated with mean hospitalization costs; inflation adjusted to 2014 US dollars. Coefficients were exponentiated to yield percentage change associated with each predictor.

RESULTS:

Among 26,417 adults with gastric cancer (mean age 65.7 ± 14 years, 36.3% female, 55.3% non-Hispanic White), 48.6% were low-medium burden, and 22.4% were hospitalized in high SNB hospitals. Overall in-hospital mortality was 7%, with no significant differences by hospital SNB. Compared to men with gastric cancer, women had significantly lower odds of in-hospital mortality (7.3% vs. 6.4%; OR 0.81, 95% CI 0.73-0.89, P < 0.001), and patients who received surgery (vs. no surgery) were less likely to experience in-hospital deaths (3.4% vs. 7.7%; OR 0.49, 95% CI 0.41-0.58, P < 0.001). Total estimated hospitalization costs were $2.5 billion. On regression, mean inpatient costs were significantly higher for hospitalizations at a low-medium SNB hospital (vs. no burden) (4.6% higher, 95% CI 0.6-8.7%, P = 0.02). Patients who underwent partial/total gastrectomy (vs. no surgery) incurred greater costs (183% higher, 95% CI 176-190%, P < 0.001).

CONCLUSION:

There were no significant differences in rates of in-hospital mortality by SNB, however, low-medium SNB hospitals bore majority of the economic burden. Men with gastric cancer were more likely to die during hospitalization. While those who received partial/total gastrectomy incurred higher costs, in-hospital mortality was lower compared to those who did not receive surgery.
1241 Are You Full? An Analysis of Online Patient Resources for Gastroparesis
Authors: Naik Katrina , Cioffi Joseph , Adhatamsoontra Praphopphat , Dave Jenny , Khan Ali , Borum Marie
Published: October 2019

INTRODUCTION:

Gastroparesis, a syndrome of objectively delayed gastric emptying in the absence of obstruction, can be a frustrating motility disorder. Affected individuals often seek online information for self-education. Systematic analysis of internet-available information is important. This study evaluated the readability and quality of easily accessible online information on gastroparesis.

METHODS:

A Google search using the term “Gastroparesis” to obtain the first 100 websites was performed. Websites were excluded if they contained veterinarian or pediatric content, were duplicates or were inaccessible. Sites were categorized by intended audience: professional or consumer. The validated Flesch-Kincaid Grade Level Calculation determined readability. The validated DISCERN questionnaire determined quality, with scores rated as Excellent >55, Good 36-55 or Poor <36. Statistical analysis was performed using Fisher's Exact Test with a P-value set at <0.05.

RESULTS:

89 websites were analyzed. 58 (65.2%) were written for consumers and 31 (34.8%) for medical professionals. 49 (55%) were created by academic institutions. The average Flesch-Kincaid Grade Level was 11.4. 6 websites (6.75%) scored a Flesch-Kincaid Grade Level of 6 or below. The mean quality was Good (DISCERN score 52.6) with 39 Excellent (43.8%), 35 Good (39.3%) and 15 Poor (16.9%). Consumer sites included significantly more recommendations for diet modifications (86.2% vs 64.5%, P < 0.03) than medical professional sites, but excluded references (27.5% vs 80.6%, P < 0.0001). Regardless of consumer status, methods of diagnosis (63.3% vs 37.5%, P < 0.02), labs (63.3% vs 37.5%, P < 0.02) and gastric pacers (63.3% vs 37.5%, P < 0.02) were discussed significantly more on academic institution websites.

CONCLUSION:

This study revealed the variability in readability and quality of online resources for gastroparesis. The majority of websites targeted consumers, yet readability exceeded the NIH 6th grade reading level recommendation for medical information. In the era of widespread internet use for acquiring health information, it is important that quality online health information resources use patient-centered language to facilitate formed decision making.
1242 Targeting Inappropriate Stress Ulcer Prophylaxis: A Multidisciplinary Approach
Authors: Mahmood Asadullah , Saeed Naba , Seyedtabaei Roheila , Saad Ali Bani , Saeidifard Farzane , Niaz Azra , McConachie Sean , John Rajiv
Published: October 2019

INTRODUCTION:

Use of stress ulcer prophylaxis (SUP), administration of acid suppressive therapies (AST) to prevent nosocomial gastrointestinal bleeding, is rampant outside of intensive care units despite a lack of data supporting its efficacy. Inappropriate use rates as high as 90% have been reported nationally. Following this, many times AST is inappropriately continued at discharge as well. Potential side effects include vitamin B12 deficiency, osteoporosis, Clostridium difficile infection, pneumonia and CKD. A multidisciplinary educational approach has been used to improve prescribing patterns in other disease states.

METHODS:

We aimed to decrease inappropriate stress ulcer prophylaxis using a multidisciplinary academic detailing team on an inpatient internal medicine teaching service (IIMTS). Using the quality improvement model plan-do-study-act (PDSA), we retrospectively collected baseline data on inappropriate SUP use on IIMTS over one month. We then implemented PDSA 1: academic detailing, whereby a multidisciplinary team (clinical pharmacist plus internist), gave teaching sessions on appropriate SUP indications to IM residents. With PDSA 2, we introduced a hard stop into IIMTS note templates. We collected prospective post-intervention data for one month after each intervention.

RESULTS:

Pre-intervention, 95 patients received AST, of which 68 (71%) were receiving AST prior to admission and 27 were prescribed AST upon admission. Overall rates of inpatient initiation of SUP decreased from 25.4% to 16.4% and then 5.4% from the pre-intervention phase to PDSA 1 and PDSA 2 respectively. Rates of inappropriate SUP use also decreased from 8.4% to 7.1% and then 4% respectively.

CONCLUSION:

Academic detailing as a means to change clinician practices through evidence-based medicine has been shown to have a risk difference of up to 16% in the literature. Furthermore, the addition of a hard stop has been shown to effectively make these changes more permanent. These strategies were successfully used in our inpatient setting to decrease inappropriate AST use, subsequently translating to a reduction in long term complications and cost accrual.
1243 The Association Between Gastroparesis and Slow Transit Constipation as Seen by Wireless Motility Capsule (WMC)
Authors: Radetic Mark , Kamal Afrin , Rouphael Carol , Cline Michael
Published: October 2019

INTRODUCTION:

Gastroparesis refers to delayed gastric emptying in the absence of a gastric outlet obstruction, as diagnosed by >10% gastric retention at 4 hours on Gastric Emptying Scintigraphy (GES). It presents with nausea/vomiting, upper abdominal fullness/discomfort, and early satiety. Several conditions can predispose patients to developing the disease, but ∼50% of affected patients are found to have idiopathic gastroparesis. The gastrointestinal tract is well connected through a series of neuronal reflexes that act to stimulate/inhibit specific segments based on stimuli detected at other “upstream or downstream” locations. The existence of a “cologastric brake” has been postulated in the past – where stimuli in the colon activate ascending tracts that may modulate upper gastrointestinal function. Based on this premise, the aim of our study was to determine the relationship between constipation and gastroparesis.

METHODS:

We conducted a retrospective study of patients who had undergone both GES as well as Wireless Motility Capsule (WMC) testing at our institution. Patients were divided into two groups based on the results of the GES: normal gastric emptying or gastroparesis. Constipation was assessed via WMC and anorectal manometry (when available). Demographic data, co-morbidities, selected labs, and medications were analyzed.

RESULTS:

A total of 224 patients were reviewed (101 with normal gastric emptying and 123 with gastroparesis). Mean colonic transit time was 2,321 min (normal <3,540 min) for patients with normal gastric emptying and 2,665 min for patients with gastroparesis (P = 0.361). There were no significant differences between the groups in demographics, co-morbidities, labs, or medications with the exception of prokinetics (P = 0.004) which were more common in the gastroparesis group. Univariate logistical regression found no association between slow-transit constipation and mild/moderate gastroparesis (OR 1.13/0.92, P = 0.82/0.81) but did find a correlation with severe gastroparesis (OR 2.45, P = 0.01). This relationship was strengthened with the exclusion of diabetes mellitus (OR 3.5, P = 0.008). Dyssynergic defecation did not appear to be associated with gastroparesis regardless of severity.

CONCLUSION:

Severe gastroparesis appears to be associated with an increased prevalence of slow-transit constipation – even more so after eliminating confounders (diabetes mellitus). Conversely, dyssynergic defecation does not appear to have any impact on gastric emptying.
1244 Symptomatic Patients Suspected of Eosinophilic Gastritis and/or Enteritis Have Elevated Mucosal Mast Cell Counts Without Eosinophilia: A New Diagnostic Entity?
Authors: Murray Joseph A. , Dellon Evan S. , Peterson Kathryn A. , Falk Gary W. , Chehade Mirna , Genta Robert M. , Gonsalves Nirmala , Rothenberg Marc E. , Khoury Paneez , Leung John , Bledsoe Adam C. , Shaw Camilla , Rasmussen Henrik S. , Singh Bhupinder , Chang Alan T. , Youngblood Bradford A. , Kamboj Amol , Hirano Ikuo
Published: October 2019

INTRODUCTION:

Eosinophilic gastrointestinal diseases (EGIDs) are a set of inflammatory diseases subclassified according to the site(s) of abnormal accumulation of eosinophils (eos) in the gastrointestinal (GI) tract such as eosinophilic esophagitis (EoE), gastroenteritis (EGE), and colitis. These conditions often decrease quality of life due to debilitating symptoms. While the pathogenesis of EGIDs is primarily thought to be driven by eos, there is increasing evidence for the involvement of mast cells (MCs). AIM: To characterize symptomatic patients (pts) with suspected EG/EGE who did not meet histopathologic entry criteria for mucosal eosinophilia for a Phase 2 randomized, double-blind, placebo-controlled study of AK002, an anti-Siglec-8 antibody.

METHODS:

To undergo screening endoscopy for this study, pts were required to report an average symptom score ≥3 (0 to 10 scale) for abdominal pain, nausea, and/or diarrhea on a daily patient-reported outcome questionnaire for ≥2 weeks and have no other known cause for GI symptoms. During the screening endoscopy, biopsies were systematically obtained from the stomach and duodenum, and read by a single pathologist. Eos counts (eos/hpf; hpf area = 0.237 mm2) were assessed on H&E slides. To quantify MCs, immunohistochemistry for tryptase was performed. We quantified eos and MCs in the stomach and duodenum. Histopathologic entry criteria for the randomized study was ≥30 eos/hpf in 5 hpfs in the stomach (EG) and/or ≥30 eos/hpf in 3 hpfs in the duodenum (EGE). A literature review was conducted to determine normal MC counts in the GI tract.

RESULTS:

Eighty-eight pts underwent screening endoscopy based upon suspected EG/EGE and active symptoms, and 72 pts met histopathologic eos criteria. All pts whose eos did not meet entry criteria (n = 16) were found to have elevated MC counts (Figure 1; reported normal range = 12-19 MCs/hpf). In these pts, the mean gastric eos count was 6 eos/hpf in 5 hpfs and mean duodenal eos count was 15 eos/hpf in 3 hpfs. In contrast, these pts exhibited a mean gastric MC count of 47 MC/hpf in 5 hpfs and a mean duodenal MC count of 49 MC/hpf in 3 hpfs. Almost all symptomatic pts screened (87/88; 99%) had elevated MC counts.

CONCLUSION:

Data from this large randomized EG/EGE study showed that symptomatic pts with suspected EG/EGE had increased mucosal MCs with or without mucosal eosinophilia. These data suggest that MCs may play a role in pts with suspected EG/EGE and raise the possibility of a unique clinical presentation driven by MCs.
1245 The Morphological Changes of Fundic Gland Polyps After PPI Therapy
Authors: Fukuda Masahide , Ishigaki Hirohito , Sugimoto Mitsushige , Mizukami Kazuhiro , Ueo Tetsuya , Abe Hisanori , Andoh Akira , Kushima Ryoji , Murakami Kazunari
Published: October 2019

INTRODUCTION:

Recent studies showed that patients on proton pump inhibitors (PPIs) have larger in size and a higher incidence of fundic gland polyps (FGPs) than patients not on PPIs. However, the morphological changes of the enlargement of FGPs after PPIs treatment was not clarified. The aim of this study was to clarify the endoscopic features and the morphological changes of FGPs in patients treated with PPIs.

METHODS:

A total of 196 endoscopic images of FGPs consisting of 87 FGPs in patients treated with PPIs (PPI group) and 109 FGPs in patients treated without PPIs (non-PPI group), all of which were pathologically diagnosed as FGPs, were compared by two endoscopists. The evaluated findings were shapes (sessile, pedunculated, semi-pedunculated), colors (isochromatic, light red, red, with hemorrhage, with black spot), surface structure (smooth, uneven) and atrophic change in back ground mucosa. The correlation between each endoscopic finding was examined.

RESULTS:

The average of polyp size was significantly larger in PPI group than that in non-PPI group (7.90 ± 4.68 mm and 3.76 ± 2.12 mm, P < 0.001). The semi-pedunculated shape (Isp) of FGPs were significantly more often seen in PPI group (67.0%) than in non-PPI group (32.2%) (P < 0.001), while the sessile shape (Is) of FGPs were significantly more often seen in non-PPI group (33.9%) than in PPI group (62.1%) (P < 0.001). Red colored FGPs and FGPs with black spots were seen only in PPI group although the number of the polyp was few (n, (%). 6, (6.9) and 5(5.7), <0.05, respectively). The uneven surface structure was significantly more often seen in PPI group than non-PPI group (n (%), 54 (62.1) and 27 (24.8), P < 0.001). Pearson's correlation analysis shows a positive correlation between the “Polyp sizes “and “Uneven surface structure” (r = 0.607, P < 0.05).

CONCLUSION:

FGPs in patients treated with PPIs shows larger, semi-pedunculated (Isp), uneven surface structure, and occasionally with red colored and black spot, compared with FGPs in patients without PPIs therapy. When FGPs became bigger, the surface of FGPs became uneven. The endoscopic morphology of FGPs will change like “red potatoes” after PPI therapy and will be difficult to distinguish from other potentially harmful polyps such as foveolar hyperplasic polyps.
1249 National and Regional U.S. Antibiotic Resistance to Helicobacter pylori Identified From a Phase 3 Clinical Trial of Treatment Naïve Patients in the United States
Authors: Hulten Kristina G. , Graham David Y. , Bibliowicz Aida , Kalfus Ira N.
Published: October 2019

INTRODUCTION:

Antibiotic resistance to Helicobacter varies by region. A 2001 report of H. pylori clinical trials noted 10.6% clarithromycin and 21.6% metronidazole resistance nationally. Regional clarithromycin resistance varied from 8.3% in the West to 13.0% in the Northeast and metronidazole resistance ranged from 22.1% in the Northeast to 27.5% in the Southeast. A 2015 Houston VAMC study noted resistance of 16.4% to clarithromycin and 20.3% to metronidazole. A recent clinical study found additional concerns for increasing resistance at both national and regional levels for H. pylori infection.

METHODS:

Isolates collected in a multi-center clinical trial (2017-2018) from de-identified patients were tested for minimal inhibitory concentrations (MICs) by agar dilution using Clinical and Laboratory Standards Institute (CLSI) methods. CLSI and EUCAST (The European Committee on Antimicrobial Susceptibility Testing) interpretive breakpoints were applied. MICs were obtained for amoxicillin, clarithromycin, metronidazole and rifabutin. Analysis provided resistance patterns for both national and regional levels.

RESULTS:

MICs were reported for 345 of 356 clinical isolates recovered from treatment-naïve patients at 55 centers (20 states) across the US. The regions were broken down as Northeast, Southeast, South, Central, and West. The MIC90 was 0.125 µg/mL for amoxicillin, 8 µg/mL for clarithromycin, 64 µg/mL for metronidazole, and ≤0.008 µg/mL for rifabutin. Across all US sites, resistance rates were: amoxicillin 6.7%; clarithromycin 17.4%; metronidazole 43.7% and rifabutin 0.0%. Regional assessment of amoxicillin, clarithromycin and metronidazole resistance was: Northeast 0.0% (n = 0), 31.6% (n = 6) and 36.8% (n = 7); Southeast: 6.1% (n = 8), 22.0% (n = 29) and 51.5% (n = 68); South 6.5% (n = 5), 11.7% (n = 9) and 45.5% (n = 35); Central 0.0% (n = 0), 44.4% (n = 4) and 22.2% (n = 2); and West 8.3% (n = 9), 11.1% (n = 12) and 35.5% (n = 38), respectively.

CONCLUSION/DISCUSSION:

Nationally, we found greater resistance rates for clarithromycin (17.4%) and metronidazole (43.7%) compared to previous reports from 2001 and 2015. Regionally, clarithromycin resistance was greater for the Northeast, Southeast and Central areas while metronidazole resistance was greater than previously reported across all regions. Amoxicillin resistance was low (6.7%: 0%-8.3%), and no resistance to rifabutin was reported. These emerging resistance patterns support the use of rifabutin based therapies for H. pylori eradication.
1254 Sarcomatoid Carcinoma of the Head of the Pancreas: A Rare Case
Authors: Tempera Patrick , Tempera Patrick
Published: October 2019

INTRODUCTION:

To the best of our knowledge, a total of 23 cases of sarcomatoid or carcinosarcoma of the pancreas have been reported.
1
Sarcomatoid carcinoma of the pancreas (SCP) is a rare and aggressive malignant neoplasm with evidence of epithelial and mesenchymal features. Confirmation of this disease currently relies on detailed pathologic examinations. SCP is comparatively more aggressive with a poorer prognosis than that of conventional pancreatic carcinomas. Therefore, SCP can be a challenge both diagnostically and therapeutically for clinicians and surgeons alike. The presenting case illustrates and highlights potential indications that can be used to diagnose and treat SCP much earlier than conventional medicine currently allows.

CASE DESCRIPTION/METHODS:

We present a case of SCP in an 84-year-old male patient. He had experienced jaundice and epigastric abdominal pain for 4 weeks. An ultrasound revealed a hypoechoic mass at the pancreatic head which prompted referral to our gastroenterology group. Physical examination revealed scleral icterus, cutaneous jaundice, and left hip and lower back pain. Laboratory tests yielded the following results: total bilirubin of 13.4 U/L, AST/ALT of 171 U/L and 240 U/L respectively, and an alkaline phosphatase of 714 U/L. Imaging examinations were performed including MRCP, EUS, and CT noting a mass in the pancreatic head. Due to the aggressiveness of this patient's tumor and despite medical efforts, the patient succumbed to his illness shortly after the official diagnosis was discovered and before any therapeutic measures could have been initiated.

DISCUSSION:

Our final diagnosis of SCP was made via pathologic examination as high-grade malignant sarcomatoid neoplasm with spindled areas, ample mitosis, and necrosis. IHC analysis showed positive expression for cytokeratin, vimentin, CD56, and a Ki-67 with a proliferative rate of greater than 90%. Other immunomarkers for melanoma, smooth muscle, and lymphoma were negative. These findings are indicative of sarcomatoid morphology and phenotype. Although definitions of SCP vary, it is believed that SCP features spindle cells and possesses mesenchymal-like and epithelial-like appearances.
1
Due to the histological report of spindle cell patterns and the co-presence of mesenchymal-like and epithelial-like cells illustrated using immunostaining techniques, our case is most consistent with SCP.
1261 Chylous Ascites in the Setting of a Pancreatic Pseudocsyt: A Rare Cause of an Even Rarer Condition
Authors: Mukherjee Samiran , Harne Prateek , Sharma Anuj , Masood Umair , Badrinath Madhuri , Manocha Divey
Published: October 2019

INTRODUCTION:

Chylous ascites is a rare entity. It is formed when triglyceride-rich fluid enters the peritoneal cavity. Although the most common cause of the same is trauma to the lymphatic ducts, rarer causes still exist for the same.

CASE DESCRIPTION/METHODS:

Our case is a 63-year-old lady who was admitted with a provisional diagnosis of severe pancreatitis with multiorgan failure. On admission, her lab results were significant for a WBC count of 23.7 and a lipase level of over 30,000. While in the hospital she had also developed acute kidney injury, requiring hemodialysis and a pulmonary embolism. On being managed for th aforementioned, she also subsequently developed an infected pancreatic pseudocyst with culture results being positive for Enterococcus spp. and Staphylococcus epidermidis. A few weeks later, the patient underwent repeat abdominal imaging to assess for the interval change in the pancreatic pseudocyst. CT of the Abdomen revealed the presence of ascites. It was initially thought to be a gynecological malignancy, but Ascitic fluid analysis revealed elevated triglyceride levels and was unremarkable for the presence of any malignant cytological cells. A diagnosis of chylous ascites was made, which had resolved on drainage of the pseudocyst. The CT of the abdomen also revealed the presence of necrotizing pancreatitis, which appeared to have resolved after the draiange of the pseudocyst.

DISCUSSION:

In summary, although the most common causes of chylous ascites are either malignancy or iatrogenic trauma, our case presents itself to be somewhat of an enigma. Our working hypothesis is that the pseudocyst may have potentially expanded to cause traumatic injury to the lymphatic channels. Although exceptionally rare, there have been a total of 13 cases of chylous ascites associated with pancreatitis, of which 7 of them happen to be chronic. This is the first case of an association with a pancreatic pseudocyst. Further, even though chylous ascites due to necrotizing pancreatitis has been reported, the fact that her symptoms resolved on drainage of the pseudocyst favours the latter as the etiological agent for the ascites.
1265 Endoscopic Ultrasound an Excellent Tool for Diagnosis of Early Stages of Cholangiocarcinoma
Authors: Arroyo-Mercado Fray Martin M. , Noel Jude , Likhtshteyn Michelle , Vignesh Shivakumar
Published: October 2019

INTRODUCTION:

Cholangiocarcinoma (CC) is a biliary tract malignancy with a poor prognosis and 3-year survival rate of 95%.1 Due to late onset of symptoms, patients often present with metastatic disease. Data suggest that endoscopic ultrasound (EUS) is an excellent tool to diagnose cholangiocarcinoma with a sensitivity varying from 60 to 89%.2–5

CASE DESCRIPTION/METHODS:

Case 1 An 80-year-old man with a 3-week history of weight loss, jaundice, and generalized pruritus underwent both ultrasound and abdominopelvic CT scan which demonstrated dilatation of the intra and extrahepatic ducts and no masses. MR with MRCP revealed a common bile duct (CBD) measuring 18 mm and a biliary stricture at the head of the pancreas; masses were not noted in the pancreas or bile duct. He subsequently underwent EUS-guided fine needle aspiration (FNA) that revealed a 9 × 6 mm hypoechoic distal CBD lesion and normal pancreatic head; FNA cytology revealed adenocarcinoma consistent with biliary origin. Based on the EUS impression and cytology, the patient was diagnosed with T1N0M0 extrahepatic cholangiocarcinoma. Case 2 A 69-year-old male with history of weight loss, jaundice, and acholic stools was found to have several pancreatic cysts clustered together, 18 mm in conglomerate with a dilated CBD to 11 mm and no masses on MR of the abdomen. A subsequent EUS showed a normal pancreas, a 1 × 1.2 cm distal CBD lesion without evidence of invasion into the pancreatic head and a 1.2 cm peripancreatic lymph node with equivocal EUS features for malignancy. FNA cytology of lymph nodes was negative for malignancy. ERCP showed a distal CBD stricture of 2 cm suspicious for malignancy; brushings showed adenocarcinoma. EUS findings were consistent with T1N0M0 extrahepatic cholangiocarcinoma.

DISCUSSION:

EUS-FNA is an established, minimally invasive diagnostic modality for pancreatico-biliary tumors with high sensitivity to diagnose tumors less than 3 cm.6 EUS has demonstrated benefit in the diagnosis and staging of extrahepatic cholangiocarcinoma, as compared to other modalities such as MRI.7 While ERCP is primarily a therapeutic modality, it can also be used for diagnosis of CC via ERCP guided forceps biopsy, brush cytology or cholangioscopic biopsy.7 Our cases highlights the utility of EUS in diagnosing early stage cholangiocarcinoma, while other imaging modalities are indeterminate. The second case also illustrates how ERCP guided brush cytology complements EUS imaging in the diagnosis of T1 extrahepatic cholangiocarcinoma.