bluuebunny/crossref_metadata_2025_split huggingface dataset:
497 MD-7246, a Delayed-Release Formulation of Linaclotide Targeting Visceral Pain Associated With IBS-D, Does Not Impact Bowel Frequency or Stool Consistency in Healthy Volunteers: Results From Phase I Trial
Authors: Kuo Braden , Bartolini Wilmin , Tripp Kenneth , Boinpally Ramesh , Borgstein Niels 
Published: October 2019

INTRODUCTION:
MD-7246 is a delayed-release formulation of linaclotide (LIN), releasing drug in the distal ileum, under development for treating visceral pain with limited pro-secretory effects. LIN, a GC-C agonist, is approved as an immediate-release (IR) formulation, releasing in the stomach, for treating irritable bowel syndrome with constipation and chronic idiopathic constipation. This study assessed the safety, tolerability, and pharmacokinetics of MD-7246 and explored select pharmacodynamic (PD) parameters.

METHODS:
This double-blind, placebo-controlled study randomized healthy adult volunteers to placebo or 1 of 3 daily doses of MD-7246 for 7 days. Safety and tolerability were assessed at each dose prior to dose escalation. PD assessments for spontaneous bowel movement [SBM]/week and stool consistency (Bristol stool form scale [BSFS]) were recorded in a diary.

RESULTS:
Placebo, low, mid, or high doses of MD-7246 were received by 6 subjects each. Neither LIN nor its active metabolite were detected in plasma after 7 days of oral administration and no intact tablets were discovered in any subject's stool. The median and interquartile range (IQR) for change from baseline (CFB) in SBM and BSFS were similar and overlapping for placebo and all 3 MD-7246 dose groups (median (IQR) CFB: SBM: -2.6 (-4.6, 2.9), -1.9 (-4.4, -1.4), -1.3 (-2.0, 0.0), and 0.0 (-7.7, 0.9); BSFS: 0.4 (-0.2, 1.0), 0.2 (-1.0, 0.9), 0.2 (-0.4, 1.0) and 0.4 (-0.3, 1.8) in placebo and low, mid, and high MD-7246 doses, respectively). MD-7246 was well tolerated and there were no adverse events of diarrhea reported in any subject (placebo or MD-7246). For comparison, the PD effects of LIN (290 µg) IR formulation was evaluated in a previous food effect study in healthy volunteers (n = 18). SBM frequency and BSFS showed an increase from baseline (median (IQR) CFB: SBM: 3.5 (3.0, 8.0) and 1.0 (0.0, 4.0); BSFS: 2.3 (2.1, 2.8) and 1.6 (1.3, 2.4) in fed and fasted state, respectively) with a greater mean CFB in the fed state vs. the fasted (P < 0.01). Diarrhea was reported in those who received IR LIN 290 µg.

CONCLUSION:
MD-7246, a delayed-release formulation of LIN, was safe and well tolerated for 7 days at all 3 doses. MD-7246 appears to have distinct clinical properties from the approved LIN 290 µg IR formulation and showed no effect on SBM frequency or stool consistency. In comparison, SBM frequency increased and stool consistency shifted to looser stools in healthy volunteers following LIN 290 µg IR QD for 7 days.
498 Objective Evidence of Gastrointestinal Disorders in Patients With 22q11.2 Deletion Syndrome
Authors: Kotcher Rebecca , Chait Daniel , Heckert Jason , Crowley T. Blaine , Ahuja Nitin K. , Mascarenhas Maria R. , McDonald-McGinn Donna , Reynolds James 
Published: October 2019

INTRODUCTION:
22q11.2 deletion syndrome (22q11.2DS) is the most common chromosomal microdeletion syndrome (1:3000-6000 live births) and the most common cause of DiGeorge Syndrome (congenital heart disease, parathyroid hypoplasia, thymic hypoplasia). However, the 22q11.2DS phenotype varies markedly among patients. We previously studied a smaller subset of patients with 22q11.2DS (n = 72) and found that chronic gastrointestinal (GI) symptoms were common. Here we expand our previous observations to a larger cohort (n = 175) and also present objective study data in an effort to characterize these GI problems as structural versus functional.

METHODS:
Adult patients with 22q11.2DS were retrospectively assessed from our cohort of >1400 patients with a confirmed 22q11.2 deletion followed in the 22q and You Center at the Children's Hospital of Philadelphia. Included patients had at least one problem list, medication list, review of systems, and outpatient physician evaluation at ≥17 years of age. Broad clinical data were abstracted, including results of relevant imaging and laboratory studies. All available imaging studies were reviewed for radiologic and pathologic abnormalities. All routine laboratory studies were reviewed, and the lowest value was recorded for each test.

RESULTS:
672 consecutive charts were reviewed, of which 175 met inclusion criteria. Included patients (45% F) ranged from 17 to 59 years of age (mean 26.1; SD 8.1). Chronic GI symptoms were common from childhood through adulthood (Figure 1), but congenital GI malformations were rare (4%). Additionally, autoimmune GI disorders occurred at the frequency of the general population [celiac disease (1%); inflammatory bowel disease (0.6%)]. However, motility disorders were common and accounted for the vast majority of GI symptoms (Figure 2). Pertinent laboratory results were also reported and showed a high rate of anemia (Figure 3).

CONCLUSION:
Specialized GI studies were performed commonly in our study population, reinforcing our prior observation that GI disorders place a significant burden on patients with 22q11.2DS. In addition to the well-described palatal abnormalities affecting this population, these studies revealed a wide range of non-structural GI problems. We conclude that a large burden of GI illness in 22q11.2DS is functional. Finally, the known chromosomal microdeletions present in patients with 22q11.2DS may provide an explanatory framework for understanding the etiology of functional GI symptoms in the general population.
511 High Risk of Ionizing Radiation Exposure Among Patients With Irritable Bowel in the United States
Authors: Hadi Yousaf , Khan Adnan Aman , Khan Salman , Naqvi Syeda Fatima , Kupec Justin T. 
Published: October 2019

INTRODUCTION:
Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disorder. While ionizing radiation exposure, and its associated cancer risk, is well-studied in other GI disorders, there is a paucity of data in the IBS population.

METHODS:
After IRB approval, a retrospective cohort study at a tertiary care referral center was conducted. Radiologic studies performed between Jan 2008-Dec 2017 on patients diagnosed with IBS were retrospectively evaluated. Data from patients whose primary care physician and gastroenterologist were in our healthcare system were included. Analyses was performed by chi square and Mann Kendall trend test and multivariable logistic regression was applied to assess independent associations. Percentage of participants receiving more than a cumulative dosage of 50 mSv (consensus threshold for high cancer risk) in the study period was calculated

RESULTS:
The mean age of participants was 40.83 years (SD: 12.12 years). 35.24% participants had a smoking history. A vast majority of participants were female (77.53%) and 55.95% of participants had a co-morbid psychiatric diagnosis. Most participants (85.46%) were on pain medications in the outpatient setting. 16 patients (7%) did not undergo any radiological study during the study period. 56 patients (24.67%) received greater than 50 mSv of cumulative effective radiation dosage during the 10-year study period. Mean yearly effective radiation dosage was 3.75 mSv per year (SD: 5.67). Mean cumulative effective radiation dosage during the study period was 37.45 mSv. A mean dosage of 27.87 mSv was attributable to studies involving the abdomen. Participants received a mean dosage of 17.59 mSv before and 19.86 mSv after the definitive diagnosis by the digestive disease clinic. Female gender, comorbid depression and anxiety, and diarrhea predominant IBS phenotype was significantly associated with an increased risk of radiation exposure (P < 0.05). Mann Kendall trend test did not reveal any change in average ionizing radiation exposure in patients during the study period (P > 0.05).

CONCLUSION:
Previous limited data from Europe hinted at a low risk of radiation exposure in IBS but we finds that, contrary to popular belief, a significant proportion of IBS patients are exposed to high levels of ionizing radiation, which potentially poses a significant cancer risk. Nationwide cohort studies are needed to assess this risk and quality improvement initiatives are needed to decrease radiation exposure in this relatively young population.
520 Pre-Endoscopic Risk Stratification Scores Associated With Intubation for Emergent Endoscopy for Severe Gastrointestinal Hemorrhage
Authors: Duong Nikki , Woo Stephanie , Xi Rebecca , d'Aliberti Olivia , Jennings Joseph 
Published: October 2019

INTRODUCTION:
Approximately 300,000 patients are admitted annually for gastrointestinal bleeding (GIB) in the US and many require emergent endoscopy. Many patients are prophylactically intubated to protect the airway in hopes of avoiding respiratory complications intra-operatively. Currently there are no guidelines to determine which patients should be intubated prior to endoscopy.

STUDY AIM:
To identify pre-procedural factors associated with intubation compared to those who undergo endoscopy without intubation and compare post-procedural outcomes.

METHODS:
Retrospective chart review from Sept 2017 to Dec 2018 of all emergent endoscopies for acute GIB. Data are presented as means with 95% ± t-test confidence intervals, or frequency (%). Analysis of variance (ANOVA), or univariate logistic regression was used for continuous variables, the Pearsons χ2 test was used for categorical variables.

RESULTS:
There were 210 procedures performed during this time frame. 142 patients were included in the final analysis after excluding endoscopies done for non-GIB indications. There was no statistically significant difference between the intubated and non-intubated groups for the following: gender, race, BMI, number of transfusions needed, or anticoagulation use [Table 1]. Mean Glasgow-Blatchford scores (GBS) and APACHE scores were higher in the intubated group than in the non-intubated group (12 vs. 10, P = .03 and 20 vs. 12, P < .01, respectively). In the intubated group, 28% of patients developed pneumonia (PNA) [Table 1]. The difference in cardiovascular outcomes trended towards significance (P = 0.07). The intubated group had higher cardiac arrest (5.7% vs. 0%) and mortality rates (24% vs. 11%) than the non-intubated group.

CONCLUSION:
We found that higher GBS and APACHE scores were associated with intubation. We also found that patients with cirrhosis or who were on pressors were more likely to be intubated. In our study, 28% of intubated patients developed pneumonia, whereas prior studies report a 14% incidence of pneumonia after intubation. The decision to intubate a patient is complex but gastroenterologists and intensivists must weigh the risks associated with intubation, such as PNA, ICU delirium, and increased length of stay in the ICU, and avoid reflexively intubating all patients. Our study shows significant differences in pre-procedure GBS and APACHE scores that could be useful for future studies as a possible tool to aid in this decision-making process.
528 A Patient-Centered Multidisciplinary Approach to Improve Inpatient Bowel Preparation for Colonoscopy
Authors: Shenoy Vinayak , Park Connie , Bhardwaj Richa , Ivanina Elena 
Published: October 2019

INTRODUCTION:
The success of colonoscopy is largely dependent on the quality of bowel preparation. Inpatient colonoscopy preparations are often suboptimal, leading to missed lesions, increased complications and poor study quality. Several studies have shown improved outcomes with split-dose bowel preparation (SBDP). As such, we conducted a multidisciplinary approach to implement a universal prep protocol (UPP) for our hospitalized patients and assessed the intervention's impact on colonoscopy quality with the Boston Bowel Prep Score (BBPS).

METHODS:
We implemented a UPP for all our inpatient colonoscopy cases that met inclusion criteria. We initiated a patient focused multidisciplinary educational intervention to implement this UPP by administering SDBP (2L PEG at 5pm the night prior to colonoscopy and 2L at 5am the morning of colonoscopy). Educational interventions included holding multiple group meetings to educate house staff and floor nursing staff on how to order and administer the split doses. Patients and staff were educated on the benefits of split prep, how to pace bowel prep intake and dietary changes prior to colonoscopy. A universal pamphlet in English and Spanish reiterating these points was created and was provided to patients and staff for reference. Six months of prospective data, which included gender, ethnicity, indication for the procedure, and BBPS, were collected and compared to a historic pre-intervention (PI) cohort.

RESULTS:
A total of 155 patient records were reviewed, of these 107 eligible patients were identified. There was no statistical difference in age, ethnicity and indication between the two groups, but there was a difference in gender with 62% of PI patients being male compared to 35% males in the intervention group (IG). The gender was adjusted for in the Linear Mixed Model, which showed a statistically significant increase in BBPS in the IG (P = 0.019, OR 0.3948).

CONCLUSION:
Achieving adequate bowel preparation in the inpatient setting is challenging. Our study showed that a patient centered multidisciplinary approach to implement a UPP and emphasizing patient and staff education significantly improved the quality of colonoscopy, as demonstrated by the BBPS. This approach also highlights how patient engagement and patient comfort are key elements of patient focused care. Other institutions should consider this framework in improving inpatient colonoscopy quality and patient outcomes.
533 Effect of Pronase on Visibility Scores During Upper Endoscopy: Systematic Review and Meta-Analysis
Authors: Jayaraj Mahendran , Dhindsa Banreet , Mohan Babu P. , Ohning Gordon 
Published: October 2019

INTRODUCTION:
Pronase is a proteolytic enzyme that helps in removal of mucous when used during the endoscopic examination by mucolytic activity. The increase in visibility during upper endoscopy and endoscopic ultrasound examination leads to identification of early cancerous lesions in the stomach.Different studies have reported varied results for using pronase as a pre-medication to improve visibility. We conducted a systematic review and meta-analysis to assess the improvement in visibility after pre-medication with Pronase in Upper endoscopy.

METHODS:
We performed a systematic search of multiple databases through May 2019 to identify studies reporting on the use of Pronase and outcomes in terms of visibility scores in upper endoscopy. Pooled visibility scores for different parts of the stomach were obtained. Heterogeneity was assessed by I2 statistics.

RESULTS:
Seven studies with a total of 2431 patients were included in the final analysis. The mean age ranged from 47 to 61 years with 44% males. majority of the studies were based out of single center data. The dose of pronase used was 20000 units in majority of the studies. Medication administration time varied. Four studies administered pronase 10 minutes before procedure, three studies administered it 20 minutes before procedure and one study used it 30 min before the procedure. Visibility scoring was done based on a scale of 1 to 4, 1 being best possible visualization. The pooled visibility score for the gastric antrum with pronase was 1.42 (95% CI: 1.2-1.6, I2 = 99); for fundus was 1.17 (95% CI: 1.1-1.2, I2 = 67.5); for lower gastric body was 1.46 (95% CI: 1.3-1.7, I2=94.5); and for upper gastric body was 1.68 (95% CI: 1.4-2, I2 = 97.3). Significant heterogeneity was noted in the analysis.

CONCLUSION:
Based on this meta-analysis the pooled visibility scores appear to be near one which is the ideal score.The optimal time of administration (pre-procedure drink or intraprocedural flushes) and the effect of pronase in improving detection of early cancerous lesion should be determined in future well controlled large studies.
544 Use of an Abdominal Compression Device in Colonoscopy Significantly Decreases Cecal Intubation Time as Compared to Conventional Colonoscopy: A Systematic Review and Meta-Analysis
Authors: Hamade Nour , Nutalapati Venkat , Chalhoub Jean M. , Chandrasekar Viveksandeep Thoguluva , Dasari Chandra , Kennedy Kevin , Kohli Divyanshoo , Sharma Prateek 
Published: October 2019

INTRODUCTION:
Looping of the endoscope is a common issue encountered during colonoscopy. A number of tools and techniques including the use of abdominal pressure devices have been utilized as an aid to reduce looping and thereby decrease the cecal intubation time. We conducted a meta-analysis comparing outcomes of colonoscopy with and without abdominal pressure devices.

METHODS:
A comprehensive electronic database (PubMed, Cochrane, and Google Scholar) search was conducted to identify studies using abdominal pressure devices. Prospective randomized studies that reported colonoscopy outcomes with and without the use of abdominal compression devices were included in the analysis. The primary outcome was the difference in cecal intubation time (in minutes) between the intervention (colonoscopy using abdominal pressure devices) and control (colonoscopy without these devices) groups. Secondary outcomes assessed: need for manual pressure and patient position changes during colonoscopy. Review manager 5.3 and R version 3.5 were used for statistical analysis.

RESULTS:
A total of 6 prospective (4 randomized) studies were included in the final analysis. There were 673 patients in the intervention group as compared to 903 patients in the control group. The mean patient age was 56.2 years with 36.9% males. 3 studies used the ColoWrap device, one used an obstetric binder, one used a commercial elastic corset, and one used the N-Doe Pillow™. For the primary outcome, cecal intubation time was significantly shorter in the intervention group (colonoscopy with abdominal compression device) compared to the control group; -1.68 minutes (95% CI: -2.5 to -0.86, I2 = 86%). Similarly, the requirement for manual pressure during colonoscopy (OR: 0.17; 95% CI: 0.07-0.43, I2 = 91%) and need for patient position change (OR: 0.25; 95% CI: 0.15-0.42, I2 = 43%) was significantly lower in the abdominal compression devices versus the control group.

CONCLUSION:
The results of this systematic review and meta analysis demonstrate that the use of abdominal compression devices is associated with a significantly decreased cecal intubation time, need for manual pressure, and for patient position change during conventional colonoscopy. These devices should be considered for use during colonoscopy especially when looping of the endoscope is anticipated.
546 Inpatient Status Is Associated With Incomplete Capsule Endoscopy Examinations: A Systematic Review and Meta-Analysis
Authors: El Iskandarani Mahmoud , El Kurdi Bara , Aasen Tyler , Alomari Mohammad , Babar Sumbal , Haddad Ibrahim , Al Momani Laith , Young Mark 
Published: October 2019

INTRODUCTION:
Capsule endoscopy (CE) has been increasingly used for the diagnosis of small bowel pathology, mainly, obscure gastrointestinal bleeding. Incomplete examination can lead to delayed intervention. Possible risks of incomplete examination have been extensively studied. We hypothesized that hospitalized patients might be at higher risk of incomplete examination due to acute illness. Therefore, we conducted a systematic review and meta-analysis to assess the effect of inpatient status on the completion of CE.

METHODS:
Unrestricted searches of MEDLINE, EMBASE, Cochrane bibliographic databases were performed inception through March 2019 for studies comparing CE completion rates in hospitalized vs. non-hospitalized patients. Results were screened for relevance and eligibility criteria. Relevant data was extracted and analyzed using Comprehensive Meta-Analysis software. The Begg and Mazumdar rank correlation test was utilized to evaluate for publication bias

RESULTS:
A total of 6 retrospective studies published between 2010-2018 were included examining 2,467 patients who underwent CE (702 inpatient vs 1,763 outpatient) were included. Outpatient CE completion rate was significantly higher compared to inpatient with an OR of 4.48 (95% CI 1.99-10.09; I2 = 85%). In three studies, small bowel transit time found to be shorter in the outpatient CE group with mean difference of -14.51 minutes (95%CI -34.87-5.84), however, this did not reach statistical significance. No publication bias was noted.

CONCLUSION:
Our findings suggests that outpatient CE was associated with higher completion rates than inpatient CE. This could be related to prolonged small bowel transit time in hospitalized patients related to acute illness, comorbidities, narcotic use, and bed rest which are more prevalent in hospitalized compared to non-hospitalized patients. Our findings suggest that it might be prudent to reserve CE examinations to the outpatient setting when possible.
552 Exploring the Role of Gastrointestinal Motility and Non-Acid Reflux in Lung Transplant Prognosis and Risk of Acute Rejection
Authors: Daniel Harrison , Gala Kushboo , Burlen Jordan , Stocker Abigail , Lorenz Doug , Ramirez Allan , Abell Thomas 
Published: October 2019

INTRODUCTION:
Lung transplant patients are at risk of developing acute rejection leading to bronchiolitis obliterans syndrome (BOS). Lung transplant patients are also known to have and/or develop gastroesophageal reflux. Acid gastroesophageal reflux has been correlated with risk of acute rejection and consequently BOS. There is however a paucity of data correlating non-acid reflux with risk of acute rejection. Our study investigated the role of non-acid reflux with lung transplant rejection.

METHODS:
131 lung transplant recipients who had post-transplant evaluation between 2012 and 2019 were studied. A total of 64 lung transplant recipients had at least 3 months of post-transplant follow up consisting of 24 hour impedance pH testing, and high-resolution manometry (HREM). Patient characteristics were summarized with counts and percentages, means and SD, or medians and interquartile ranges (IQR) as appropriate to scale and distribution. The characteristics of those with and without rejection diagnoses was compared with Fisher's exact test for categorical variables and the Wilcoxon rank sum test for quantitative variables. Analyses were conducted in the open source R software environment.

RESULTS:
60 of 64 patients (94%) were alive at one-year post- lung transplant. The majority of patients had bilateral transplants and were Caucasian males with average age of 59 years. At one year there were 12 deaths. Patients with a diagnosis of acute rejection were less likely to exhibit gastroparesis (1% vs. 9%) and abnormal pH (28% vs. 45%). Acute rejection patients were more likely to exhibit GERD (53% vs. 45%), more non-acid episodes (median 19 vs. 15.5), higher reported symptom association (51% vs. 41%), on impedance pH; abnormal UES (56% vs. 45%), and abnormal body (86% vs. 77%) on HREM (Table 1). However, no differences were statistically significant (all P > .18), and conclusions cannot be generalized.

CONCLUSION:
Patients undergoing lung transplantation were found to have a high incidence of abnormal gastroesophageal motility studies, including both acid and non-acid reflux. Developing a protocolized pre- and post- transplant motility evaluation process for lung transplant patients may help identify those at greatest risk for acute rejection. Continued evaluation post-transplantation to establish therapeutic interventions in both acid and non-acid reflux patients to prevent lung transplant rejection appears warranted.