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American Journal of Gastroenterology

Ovid Technologies (Wolters Kluwer Health)

All preprints, ranked by how well they match American Journal of Gastroenterology's content profile, based on 17 papers previously published here. The average preprint has a 0.02% match score for this journal, so anything above that is already an above-average fit. Older preprints may already have been published elsewhere.

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Use of the EsoGuard(R) Molecular Biomarker Test in Non-Endoscopic Detection of Barrett's Esophagus among High-Risk Individuals in a Screening Population

Shaheen, N.; Othman, M.; Taunk, J.; Chang, K. J.; Jaganmohan, S.; Yachimski, P. S.; Fang, J. C.; Spataro, J. S.; Verma, S.; Lee, V. T.; deGuzman, B. J.; Aklog, L.

2024-06-25 gastroenterology 10.1101/2024.06.24.24309401 medRxiv
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Background and AimsBarretts Esophagus (BE) is the precursor to esophageal adenocarcinoma (EAC). We aimed to assess performance, safety, and tolerability of the EsoGuard (EG) assay on samples collected non-endoscopically with the EsoCheck (EC) device (EG/EC) for BE detection in the intended-use population, meeting American College of Gastroenterology (ACG) guideline criteria (chronic gastroesophageal reflux disease (GERD) and 3+ additional risk factors). MethodsWe performed a prospective, multicenter study (NCT04293458) to assess EG performance (primary endpoint) on cells collected with EC, for detection of BE and EAC using esophagogastroduodenoscopy (EGD) and biopsies as the comparator. Twenty-four sites across the U.S. and Spain participated. EC safety and usability were assessed as secondary endpoints. Results180 male subjects aged >50 years with chronic GERD met eligibility criteria, of which 163 (90.6%) had EGD and successful EC administration. Mean age was 60.5yrs, 34.4% were obese, 56.7% had tobacco history, and 3.9% had a 1st degree relative with BE or EAC. Of 122 samples analyzed, 93 contributed to the primary endpoint analysis. About 9% of subjects in the Primary Analysis Population had BE on EGD, none with dysplasia. Sensitivity of EG for BE was 87.5% (95% CI 47.4-99.7), specificity was 81.2% (95% CI 71.2-88.8), positive predictive value was 30.4% (95% CI 13.2-52.9), and negative predictive value was 98.6% (95% CI 92.3-99.96). Mild esophageal abrasions were observed in 1.5%; no serious adverse events were reported. ConclusionsEG/EC appears effective for BE screening. This approach provides a safe, accurate, and well-tolerated non-endoscopic alternative in high-risk patients.

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Opportunistic Upper Endoscopy at the Time of Screening Colonoscopy: Feasibility, Acceptability, and Patient Perspectives

In, H.; De la Torre-Cisneros, K.; Brijesh, R.; Myrthil-Harder, P.; Adams, A.; Dalal, I.; Patel, A.; Kesavarapu, K.; Zhou, Z.; Jhala, N.; Handorf, E.; Kinney, A.

2026-01-27 gastroenterology 10.64898/2026.01.26.26344849 medRxiv
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ObjectivesGastric cancer (GC) is a leading cause of cancer mortality in the United States (U.S.), yet no routine screening strategy exists. Opportunistic upper endoscopy (EGD) performed during screening colonoscopy (EGD-SC) may provide a practical early detection approach. We evaluated the feasibility, acceptability, patient perspectives, and diagnostic yield of EGD-SC. MethodsThis single-center, open-label, single-arm prospective trial enrolled adults aged 45-80 years scheduled for colonoscopy without prior EGD in the past five years. Feasibility was assessed by enrollment, added procedural time, and safety. Acceptability, patient beliefs, motivators, barriers, and satisfaction were assessed using pre- and post-procedure surveys. Gastric biopsies evaluated for precancerous lesions. ResultsOf individuals contacted, 51.6% expressed interest and 26.6% enrolled (n=50; median age 56; 48% male; 68% high-risk). Median added time was 17 minutes (range 9-26), with no complications. All participants rated EGD-SC as satisfactory (100%) and 90% as acceptable; most preferred the combined procedure (97.5%) and would recommend it to family or friends (92.5%). Knowledge gaps were common: nearly half lacked awareness of GC risk factors; although 72% viewed screening as beneficial, only 23.3% perceived GC as severe, and none considered themselves highly susceptible. EGD found H. pylori infection (32%), atrophic gastritis (14%), and intestinal metaplasia (12%), with higher prevalence among high-risk participants. ConclusionsEGD-SC is feasible, safe, and highly acceptable, with strong patient endorsement and meaningful detection of GC precursor lesions. These findings support risk-stratified EGD-SC as a promising and pragmatic strategy for GC prevention and early detection in the U.S.

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Clinical Utility Study of EsoGuard on Samples Collected with EsoCheck as a Triage Test for Endoscopy to Identify Barrett's Esophagus - Interim Data of the First 275 Subjects

Lister, D.; Fine, A.; Maheshwari, S.; Bradley, P. S.; Lee, V. T.; deGuzman, B. J.; Verma, S.; Aklog, L.

2023-09-02 gastroenterology 10.1101/2023.08.31.23294916 medRxiv
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BackgroundBarretts Esophagus (BE) is the only known precursor for esophageal adenocarcinoma (EAC), a highly lethal malignancy which has had increasing incidence in Western populations over the last 40 years. Recommendations are for endoscopic screening of patients with multiple risk factors for BE, however most eligible patients are not undergoing such evaluation, or failing to be referred, leading to most patients with EAC being diagnosed without an existing BE diagnosis. EsoGuard(R) (EG) is a commercially available biomarker test for detection of BE, and when used to analyze cells collected non-endoscopically with EsoCheck(R) (EC), may serve as an easily accessible and well-tolerated diagnostic tool that has been recognized by the ACG and AGA as a reasonable alternative to screening endoscopy. The aim of this study was to evaluate the clinical utility of EG as a triage test for upper endoscopy in the diagnose BE in real world use. MethodsWe present the first data snapshot from a multi-center, observational trial evaluating the CLinical Utility of EsoGuard (CLUE) among physicians who have adopted the technology into their clinical practice. At the time of data snapshot, four centers had contributed to enrollment of 275 subjects between February 23, 2023, to July 28, 2023. Participating centers followed their own standard practices for determining whom to test with EG on cells collected with EC and subsequent management of the patient following results. Demographics, risk factors, test results, and subsequent management decisions were collected and analyzed. The clinical utility of the technology was evaluated based on the impact of the EG test results on the ordering physicians decision to refer or not refer a patient for further endoscopic evaluation. ResultsAmong 275 subjects contributing data for analysis, the average age was 61.9 years, and there was a similar distribution among males and females. Eighty-nine-point seven percent (89.7%) reported a history of chronic GERD, and 73.8% had GERD plus an additional 3 BE risk factors (i.e., ACG screening cohort). 232 subjects had EG results documented at the time of data analysis, among which 229 also had a physician decision on endoscopy referral. Total EG positivity rate was 29.3% (68/232) and 65.5% (152/232) were negative; the positive agreement between positive EG results and referral for endoscopy was 100%. The negative agreement between a negative EG result and non-referral for endoscopy was 99.3%. The overall concordance between EG result and endoscopy referral was 98.8%. This did not substantially differ between the ACG screening cohort compared to others. ConclusionsData from the first snapshot of the CLUE study demonstrates physicians ordering EC/EG in the commercial setting are reliably utilizing EG results as a triage tool to guide referrals for endoscopic evaluation of BE. Physicians always refer EG(+) individual for additional endoscopic evaluation, whereas EG(-) subjects are consistently being spared an invasive test.

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Peroral Endoscopic Myotomy Versus Laparoscopic Heller Myotomy for Achalasia: A Meta-Analysis of Randomized Controlled Trials

Ramteke, H. D.; Sanapala, K.; Das, A.; Shreya, B.; Paul, S.; Jilakaraju, B.; Bodipudi, V.; Senthilkumar, V.; ambala, M.; Noor-Ain, S. H.; Khan, R.

2025-09-18 gastroenterology 10.1101/2025.09.16.25335767 medRxiv
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IntroductionAchalasia is a rare primary esophageal motility disorder characterized by impaired lower esophageal sphincter relaxation and dysphagia. Laparoscopic Heller myotomy (LHM) has long been the standard treatment, while peroral endoscopic myotomy (POEM) has emerged as a minimally invasive alternative. Comparative evidence from randomized controlled trials (RCTs) remains limited, and outcomes such as gastroesophageal reflux disease (GERD) and clinical remission require clarification. MethodsWe systematically searched PubMed, Embase, Cochrane CENTRAL, and Web of Science to September 2025 for RCTs comparing POEM and LHM in adult patients with achalasia. Data on demographics, previous treatment, dysphagia improvement, GERD incidence, clinical remission, and mortality were extracted. Pooled odds ratios (OR) with 95% confidence intervals (CI) were calculated using a random-effects model in Stata 18. ResultsSeven RCTs involving 900 patients (465 POEM; 465 LHM) were included. Dysphagia improvement was similar between groups (log OR 0.14; 95% CI -0.32 to 0.59; p = 0.55). GERD incidence was higher after POEM but not statistically significant (log OR 0.59; 95% CI -0.08 to 1.25; p = 0.08). Clinical remission showed a non-significant trend favoring POEM (log OR 0.39; 95% CI -0.06 to 0.84; p = 0.09). Reduction in pH levels significantly favored LHM (log OR 0.75; 95% CI 0.18 to 1.33; p = 0.01). No mortality was reported. ConclusionPOEM and LHM provide comparable dysphagia relief and clinical remission in achalasia. However, POEM is associated with higher GERD risk, particularly on pH monitoring. Treatment choice should balance efficacy against reflux risk, with careful long-term follow-up.

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Non-Endoscopic Screening for Barrett's Esophagus Using a DNA Methylation-Based Assay: 18-Month Real-World Experience in 11,991 Patients

Smith, M. S.; Chen, W. T.; Kotfila, R. P.; Panzarella, P. S.; Le, I. T.; Verma, S.; Lee, V. T.; Aklog, L.

2025-11-21 gastroenterology 10.1101/2025.11.20.25340693 medRxiv
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BackgroundBarretts esophagus (BE), characterized by specialized intestinal metaplasia (SIM), is the precursor to esophageal adenocarcinoma (EAC). Despite published BE screening guidelines for at-risk individuals, uptake of endoscopic screening remains low. We present 18 months of real-world data on non-endoscopic BE screening using EsoGuard(R) (EG), the first commercially available U.S. molecular biomarker test for this purpose, performed on esophageal cell samples collected with the swallowable EsoCheck(R) (EC) balloon-capsule device. MethodsWe retrospectively analyzed EC performance and EG results in patients tested commercially from January 2023 to June 2024. A subset enrolled in a registry underwent follow-up endoscopy. Multivariable logistic regression was used to evaluate risk factors associated with (1) positive EG results, and (2) confirmed BE (SIM [&ge;]1 cm). ResultsAmong 11,991 tested patients, 11,355 (94.7%) had successful EC cell collection, averaging under 2 minutes with no serious adverse events. EG was positive in 16.6% of patients, with positivity increasing by age; age > 50 years was the strongest individual risk factor for predicting a positive EG result. Among 177 EG-positive registry patients who underwent endoscopy, 59 (33.3%) had SIM, of which 33 met American College of Gastroenterology criteria for BE and 26 had ultra-short SIM (<1 cm). Dysplasia was found in 3 patients: 1 HGD, 1 LGD, and 1 indefinite for dysplasia (IND). ConclusionsWe report here the largest real-world experience of EG and EC to date, demonstrating excellent safety, tolerability, and scalability. EG detects both guideline-recognized and ultra-short SIM, supporting its utility as a non-invasive BE screening tool.

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Enhancing the Positive Predictive Value of EGD for Diagnosis of Barrett's Esophagus Through EsoGuard(R) Triage

Kurland, J. E.; Patel, S. B.; Englehardt, R.; Dezfoli, S.; Tseng, D. M.; Foutz, M. W.; Bradley, P. S.; Eghterafi, B.; Lee, V. T.; Verma, S.; deGuzman, B. J.; Aklog, L.

2024-07-27 gastroenterology 10.1101/2024.07.26.24311013 medRxiv
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BackgroundGuidelines support Barretts esophagus (BE) screening, but most eligible patients do not undergo endoscopic evaluation; non-endoscopic strategies are now supported as a reasonable alternative by U.S gastroenterology societies. EsoGuard (EG) is a DNA assay used with EsoCheck, a non-endoscopic cell collection device for detection of BE, which can be utilized as a triage to esophagogastroduodenoscopy (EGD) in patients meeting screening criteria. In doing so, EG may serve to enrich the population undergoing EGD, resulting in more BE diagnoses while potentially reducing utilization of already-limited endoscopy resources. AimTo test the hypothesis that BE detection in EGDs performed on EG positive patients will be significantly higher than the positive predictive value (PPV) of screening EGD alone. MethodsReal-world data was retrospectively collected from EG positive patients for whom EGD diagnoses were available. Baseline patient characteristics, risk factors, and EGD results were obtained from the treating physicians. PPV of screening EGDs was the comparator and estimated by literature-established disease prevalence of BE, which in the U.S gastroesophageal reflux disease population is [~]10.6%. The hypothesis was tested using t-tests for single proportions at a one-sided 5% significance level. ResultsData from 209 patients found 60 (28.7%) subjects with salmon-colored mucosa on EGD and specialized intestinal metaplasia on histopathology. However, 10 (4.8%) had < 1cm of disease on visual inspection, therefore, did not meet the American College of Gastroenterology definition of BE so was excluded from the analysis. Of the remaining 199 patients, 50 (25.1%) had BE on EGD. In the cohort of patients meeting ACG screening criteria, 28.9% (33/114) had BE. Overall, a 2.4-fold increase in BE detection was observed compared to the PPV of screening EGD, and in the ACG cohort this increase was 2.7-fold. Among ACG patients [&ge;]65 years old, the increase was nearly 2.5-fold (25.9% detection rate). ConclusionsOur data suggests EG and EC used as a triage test enriches the population undergoing EGD for BE, and compared to screening EGD alone, can help direct more efficient use of endoscopy resources to unburden the system without reducing the number of eligible patients screened and diagnosed.

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Screening Implications for Distribution of Colorectal Cancer Subsite by Age

Lin, G.; Hein, D.; Liu, P.-H.; Singal, A.; Sanford, N.

2023-07-23 gastroenterology 10.1101/2023.07.18.23292663 medRxiv
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ObjectivesThe effectiveness of colonoscopy to reduce colorectal cancer (CRC) mortality is extrapolated from cohort studies in the absence of randomized controlled trial (RCT) data, whereas flexible sigmoidoscopy is supported by RCT data and may be easier to implement in practice. We characterized the anatomic distribution of CRC to determine the proportion that is visible with sigmoidoscopy. MethodsPatients with a primary diagnosis of colorectal adenocarcinoma were identified in the Surveillance, Epidemiology, and End Results program (2000-2020). Tumors from the rectum to descending colon were categorized as visible by sigmoidoscopy, whereas more proximal tumors as requiring colonoscopy. Differential prognosis between tumor locations, stratified by age groups and stage, were assessed using overall restricted mean survival time (RMST) at 2, 5, and 10 years. ResultsAmong 309,466 patients, 58% had tumors visible by sigmoidoscopy, including 73% of those under age 50 (OR 2.10, 95%CI 2.03-2.16 age <45, OR 2.20, 95%CI 2.13-2.27 age 45-49 versus age >50). Male sex (OR 1.54, 95%CI 1.51-1.56) and Asian or Pacific Islander race (OR 1.60, 95%CI 1.56-1.64) were also positively associated with tumors visualizable by sigmoidoscopy. Across age groups, for local disease, RMST was comparable for tumors visible versus not visible on sigmoidoscopy. For regional and metastatic cancer, patients with tumors visible by sigmoidoscopy had improved RMST versus those with more proximal tumors. ConclusionsMost CRC arise in locations visible by flexible sigmoidoscopy. Flexible sigmoidoscopy should be considered as a viable option for CRC screening, particularly in younger patients unwilling or unable to undergo colonoscopy.

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Impact of a Smart Phone-Based Educational Video on Bowel Preparation and Colonoscopy Adherence: A Propensity Score Matched Analysis

Chew, K.; Galeano, D.; Behin, D.; Kumar, A.; Maheshwari, R.; Aliasi-Sinai, L.; Southern, W.; Arora, S.

2025-03-15 gastroenterology 10.1101/2025.03.13.25323456 medRxiv
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Background and AimsInadequate bowel preparation and high cancellation rates hinder the effectiveness of colonoscopy screening programs. We aimed to evaluate the impact of a novel, personalized video messaging platform on bowel preparation quality and colonoscopy adherence. MethodsWe conducted a before-after intervention study at a large urban academic medical center, comparing outcomes between a historical control group (April-September 2022) and an intervention group receiving personalized video messages (July-November 2023). Primary outcomes were inadequate bowel preparation and colonoscopy cancellation/rescheduling rates. Propensity score matching and multivariable logistic regression were used to adjust for potential confounders. ResultsAmong 1,647 patients who underwent colonoscopy, inadequate bowel preparation occurred in 12.0% of the intervention group versus 20.0% of the historical control group in the propensity score matched analysis (p=0.041). In the larger cohort of 2,802 scheduled patients, the propensity score matched analysis showed a trend toward a 31% reduction in odds of cancellation or rescheduling associated with the educational video, although this did not reach statistical significance (OR 0.69, 95% CI 0.47-1.01, p=0.056). For the logistical regression model, the video was associated with a 42% reduction in odds of cancellation or rescheduling (adjusted OR 0.58, 95% CI 0.44-0.77, p<0.001). ConclusionsImplementation of a personalized video messaging platform was associated with significant improvements in bowel preparation quality and substantial reductions in colonoscopy cancellations/rescheduling. This easily scalable, low-cost intervention has the potential to enhance the efficiency and effectiveness of colonoscopy screening programs.

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Geldof Expert Consensus Classification of Perianal Fistulizing Crohn's Disease: A Real-World Application in a Serial Fistula MRI Cohort

Schroeder, M. K.; Abushamma, S.; George, A. T.; Balakrishna, R.; Hickman, J.; Elumalai, A.; Wise, P.; Zulfiqar, M.; Ludwig, D. R.; Shetty, A.; Viswanath, S. E.; Luo, C.; Sebastian, S.; Ballard, D.; Deepak, P.

2024-02-04 gastroenterology 10.1101/2024.02.03.24302160 medRxiv
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Background and AimsPerianal fistulizing Crohns disease (CD-PAF) is an aggressive phenotype of Crohns disease (CD) defined by frequent relapses and disabling symptoms. A novel consensus classification system was recently outlined by Geldof et al. that seeks to unify disease severity with patient-centered goals but has not yet been validated. We aimed to apply this to a real-world cohort and identify factors that predict transition between classes over time. MethodsWe identified all patients with CD-PAF and at least one baseline and one follow-up pelvic (pMRI). Geldof Classification, disease characteristics, and imaging indices were collected retrospectively at time periods corresponding with respective MRIs. ResultsWe identified 100 patients with CD-PAF of which 96 were assigned Geldof Classes 1 - 2c at baseline. Most patients (78.1%) started in Class 2b, but changes in classification were observed in 52.1% of all patients. Male sex (72.0%, 46.6%, 40.0%, p = 0.03) and prior perianal surgery (52.0% vs 44.6% vs 40.0%, p = 0.02) were more frequently observed in those with improved. Baseline pMRI indices were not associated with changes in classification, however, greater improvements in mVAI, MODIFI-CD, and PEMPAC were seen among those who improved. Linear mixed effect modeling identified only male sex (-0.31, 95% CI -0.60 to -0.02) with improvement in class. ConclusionGeldof classification highlights the dynamic nature of CD-PAF over time, however, our ability to predict transitions between classes remains limited and requires prospective assessment. Improvement in MRI index scores over time was associated with a transition to lower Geldof classification.

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Clinical Utility of EsoGuard as a Triage Test for Endoscopy to Identify Barrett's Esophagus in Fire Fighters

Hamblin, R.; Lee, V. T.; deGuzman, B. J.; Verma, S.; Aklog, L.

2023-08-29 gastroenterology 10.1101/2023.08.16.23294176 medRxiv
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BackgroundFirefighters have frequent exposure to compounds shown to increase risk of esophageal neoplasia. EsoGuard(R) (EG) is a DNA biomarker assay that can be utilized with efficiency and high tolerability as a triage to endoscopy for diagnosis of patients with Barretts Esophagus (BE), a known precursor to esophageal adenocarcinoma (EAC). This diagnostic tool may facilitate disease testing among busy at-risk firefighters. MethodsRetrospective analysis of prospectively collected clinical utility (CU) data for use of EG as a triage to more invasive endoscopic evaluation. EG was performed on esophageal cell samples collected with the nonendoscopic EsoCheck(R) (EC) device during two large cancer and pre-cancer screening events for firefighters in San Antonio, TX, in January 2023. CU was evaluated by provider impact assessment. Results388 firefighters were identified for EG testing, of which >99% (385/388) successfully completed EC cell collection. Over 96% (372/385) of tests had binary results; the remaining <4% failed analysis due to insufficient DNA. The EG positivity rate was 7.3% (28/385), all of whom were referred for specialist and upper endoscopy evaluation. Among those who tested negative, none were referred for further diagnostic workup. This represented a 100% concordance between EG results and physician management decisions. ConclusionsThis study capturing real-world data on use of EG in a population of firefighters demonstrates its ability to test many individuals rapidly and efficiently in a well-tolerated fashion, and reliable use of the test to triage individuals prior to pursuing more invasive and time-consuming diagnostic approaches.

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Intraluminal Prucalopride Increases Propulsive Motor Activitiesin the Human Colon

Shokrollahi, M.; Wang, X.-Y.; Milkova, N.; Huizinga, J. D.; Chen, J.-H.

2020-05-26 gastroenterology 10.1101/2020.05.24.20111930 medRxiv
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BackgroundLuminal application of 5-HT4 receptor agonists can increase peristalsis in the guinea pig, mouse, rat and rabbit colon. Our aim in the present study was to test the effects of intraluminal prucalopride on motor patterns in the human colon. MethodsColonic motor patterns were studied in vivo in a healthy volunteer using High-Resolution Colonic Manometry (HRCM) with an 84-sensor water perfused catheter with 1cm spacing. 5-HT and 5-HT4 receptor immunohistochemistry was performed on human tissue biopsies throughout the colon. Key resultsActivating mucosal 5-HT4 receptors via intraluminal prucalopride enhanced propulsive motor activity in the human colon by increasing occurrence and amplitude of propulsive motor patterns including high-amplitude propagating pressure waves (HAPWs), pancolonic simultaneous pressure waves (SPWs) and HAPW-SPWs. Prucalopride-induced motor patterns had a close temporal association with a significant degree of anal sphincter relaxation and some were accompanied by a strong urge to defecate. Biopsies showed 100% colocalization of the 5-HT4 receptor to enterochromaffin cells throughout the colon and rectum. Conclusions and inferencesActivating luminal 5-HT4 receptors on enterochromaffin cells by intraluminal prucalopride increased propulsive motor activity. 5-HT4 receptors were found only on enterochromaffin cells and not ubiquitous on all epithelial cells. Our data support incorporation of prucalopride in colon-specific drug delivery systems as a prokinetic to treat colonic hypomotility disorders. 50 word abstractHigh-resolution colonic manometry and biopsy immunohistochemistry revealed that 5-HT4 receptors in the lumen of the human colon are present exclusively on enterochromaffin cells and that the 5-HT4 agonist prucalopride evokes all major propulsive motor patterns, associated with significant anal sphincter relaxation, when given intraluminally. 250-character clinical messageActivating luminal 5-HT4 receptors on enterochromaffin cells by intraluminal prucalopride increased propulsive motor activity in the human colon. Colon-specific delivery systems with a 5-HT4 agonist may become the preferred colon prokinetic.

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Real World Experience and Clinical Utility of EsoGuard(R) - Interim Data from the Lucid Registry

Englehardt, R.; Samarasena, J. B.; Bildzukewicz, N. A.; Hamblin, R.; Lee, V. T.; Verma, S.; deGuzman, B. J.; Aklog, L.

2023-09-27 gastroenterology 10.1101/2023.09.26.23296162 medRxiv
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BackgroundBarretts Esophagus (BE) is the only known precursor to esophageal adenocarcinoma (EAC), and guidelines exist for screening, surveillance, and treatment. However, historically most high-risk individuals have not been reliably screened, likely due to a combination of factors associated with patient/physician awareness and use of upper endoscopy (UE) as the traditional screening test. EsoGuard(R) (EG) is a DNA biomarker assay, and EsoCheck(R) (EC) is a non-invasive, swallowable capsule device designed to collect cells from a targeted region of the esophagus. EG and EC in combination offers a well-tolerated, accessible, in-office triage test to improve detection of BE in patients with multiple risk factors. The Lucid Registry captures real-world data from the commercial use of EC with EG, and we present an interim review of clinical utility data from the first 517 enrolled subjects. MethodsMulticenter, prospective, registry designed to capture data from patients undergoing EC cell collection and EG testing in the commercial setting. Data collection consists of demographics, risk factors, test results, provider management, and early clinical outcomes (through a maximum of four months post-EG). This data snapshot includes subjects enrolled from the start of the registry (April 14, 2023), through August 16, 2023. The primary assessment of clinical utility was agreement between EG assay results and physicians decision on whether to refer the patient for subsequent UE. The relationship between BE/EAC risk factors and EG positivity rates was assessed. ResultsAmong 517 subjects enrolled, average age was 47.9{+/-}14.3 years, 47.2% had history of gastroesophageal reflux disease (GERD), and 63.8% had a minimum of 3 established BE risk factors (i.e., met American Gastroenterological Association (AGA) criteria for screening). 58.8% of subjects were firefighters; when firefighting i.e., occupational exposure to smoke and carcinogens is treated as an additional BE/EAC risk factor (+) those of the AGA, 81.2% of the study population had [&ge;]3 risks, making up the "AGA(+)" cohort. EG positivity was 14.1%. 437 subjects contributed data for the clinical utility endpoint: agreement between positive EG results and subsequent referral for UE was 100%; agreement between negative EG results and non-referral for UE was 99.4%; concordance between EG results and UE referral decisions was 97.9%. These findings were comparable between the AGA and AGA(+) cohorts. ConclusionsExperience from the Lucid Registry demonstrates that physicians who have adopted EC/EG in the commercial setting are reliably utilizing EG as a triage test to inform decision making on which patients to refer for further endoscopic evaluation of BE.

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Gastric Alimetry testing and healthcare economic analysis in nausea and vomiting syndromes

Xu, W.; Williams, L.; Serebatnam, G.; Varghese, C.; Cedarwall, C.; Daker, C.; Keane, C.

2023-09-07 gastroenterology 10.1101/2023.09.07.23295185 medRxiv
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BackgroundChronic nausea and vomiting syndromes (CNVS), gastroparesis and functional dyspepsia (FD) are complex disorders. Body Surface Gastric Mapping (BSGM), a new test of gastric function, using Gastric Alimetry(Alimetry, New Zealand) may be useful for de-escalating healthcare utilisation. This study aimed to define healthcare costs and estimate health economic impacts of implementing this test in patients with chronic gastroduodenal symptoms. MethodsConsecutive patients at a tertiary referral centre evaluated with Gastric Alimetry were included. Frequency and cost data relating to medical investigations, hospital, and outpatient presentations were evaluated. Costs of healthcare utilisation were calculated, and the potential cost savings of implementing Gastric Alimetry within a diagnostic decision-tree model were estimated. ResultsOverall, 31 consecutive patients (mean age 36.1 years; 83.9% female; predominant symptoms: nausea [83.9%], pain [61.3%], vomiting [67.7%], bloating [35.5%]) completed Gastric Alimetry testing. Repeat gastroscopy and abdominal CT rates were 29% (8/28) and 85% (11/13) respectively. Gastric Alimetry testing identified spectral abnormalities in 45.2% of patients, and symptom profiling classified a further 29.1% of patients. Median annualised cost difference after test introduction was NZ$-12,032. Estimated reductions in investigation-related costs when incorporating Gastric Alimetry into the diagnostic workflow model were approximately NZ$1,500 per patient. ConclusionsHealthcare utilisation and confirmatory testing rates remain high in nausea and vomiting syndromes. This study presents real-world data, together with a decision tree analysis, showing Gastric Alimetry can streamline clinical care pathways, resulting in reduced healthcare utilisation and cost.

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Deep Learning Tissue Analysis Diagnoses And Predicts Treatment Response In Eosinophilic Esophagitis

Javaid, A.; Fernandes, P.; Adorno, W.; Catalano, A.; Ehsan, L.; Vizthum von Eckstaedt, H.; Khan, M.; Raghavan, S. S.; McGowan, E.; Barnes, B.; Moskaluk, C. A.; Collins, M. H.; Rothenberg, M. E.; Brown, D. E.; Syed, S.

2021-06-16 gastroenterology 10.1101/2021.06.10.21258624 medRxiv
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BackgroundEosinophilic Esophagitis (EoE) is a chronic inflammatory condition diagnosed by [&ge;]15 eosinophils (Eos) per high-power field (HPF). There is no gold standard for clinical remission and Eo-associated metrics are poorly correlated with symptoms. Deep learning can be used to explore the relationships of tissue features with clinical response. ObjectivesTo determine if deep learning can elucidate tissue patterns in EoE that predict treatments or symptoms at remission. MethodsWe created two deep learning models using esophageal biopsies from histologically normal and EoE patients: one to identify Eos in esophageal biopsies and a second to broadly classify esophageal tissue as EoE vs. normal. We used these models to analyze biopsies at diagnosis and first remission timepoint, as defined by <15 Eos/HPF, in a subset of 19 treatment-naive patients. Differences in deep learning metrics between patient groups were assessed using Wilcoxon Rank-Sum tests. ResultsAll initial patients were symptomatic at diagnosis and a majority were still suffering from dysphagia at remission. The Eo identification model had a low mean (SD) error of -0.3 (11.5) Eos/HPF. Higher peak and average Eo counts at diagnosis were associated with higher likelihood of being on a food-elimination diet at remission than steroids or proton-pump inhibitor (p<0.05). The EoE classification model had an F1-score of 0.97 for distinguishing normal tissue from EoE. There was a significant decrease from diagnosis in the percentage of EoE-classified tissue among asymptomatic remission patients (p<0.05). ConclusionsDeep learning may have utility in diagnosing EoE and predicting future treatment response at diagnosis and resolution of symptoms at follow-up. Clinical Implications or Key Messages (for mechanistic article)We developed two deep learning approaches for tissue analysis in eosinophilic esophagitis, which may improve histologic assessment of patients at diagnosis and predict treatment response and symptoms at remission. Capsule summaryTwo deep learning approaches for eosinophilic esophagitis (EoE): (1) Quantification of eosinophils throughout an entire biopsy, which predicted treatment at remission (2) Classifying esophageal tissue as EoE or normal, which predicted symptoms at remission.

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Device-measured moderate-to-vigorous physical activity and prognosis of inflammatory bowel disease

He, Z.; Sun, Y.; Huang, H.; Liu, Y.; Dan, L.; Ruan, X.; Fu, T.; Li, Z.; Wang, X.; Chen, J.; Bai, Y.

2024-11-01 gastroenterology 10.1101/2024.10.30.24316417 medRxiv
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ImportanceEvidence on physical activity recommendations for inflammatory bowel disease (IBD) patients is limited, with concerns about high-intensity activity. ObjectiveTo investigate the associations of accelerometer-measured moderate-to-vigorous physical activity (MVPA) with bowel resection risk and mortality among individuals with IBD. Design, setting, and participantsThis longitudinal cohort study collected data from 1,303 UK Biobank participants with IBD diagnosis and device-measured physical activity from 2013 to 2015, with follow-up data examined until 2022. ExposuresMVPA was classified based on data measured by wrist-worn accelerometers over a 7-day period. MVPA patterns were defined as inactive (< 150 minutes/week), active weekend warrior ([&ge;] 150 minutes/week, [&ge;]50% of total MVPA achieved in 1-2 days), and regularly active ([&ge;] 150 minutes/week, not active weekend warrior). Main Outcomes and MeasuresThe bowel resection was identified through operational records from hospital inpatient data of the National Health Service. Deaths were documented through linkage to the national death register. Associations were estimated using multivariable Cox regression models and nonlinearity was assessed by restricted cubic spline. ResultsDuring a median follow-up of 7.8 years, 56 incident bowel resection cases and 86 deaths were documented. After multivariable adjustment, participants in the highest tertile of MVPA duration had lower risks of bowel resection (HR, 0.44; 95% CI, 0.22-0.86) and mortality (HR, 0.49; 95% CI, 0.27-0.89) compared to those in the lowest tertile. MVPA duration is linearly associated with bowel resection (P non-linear = 0.13) while its dose-response relationship with mortality plateaus at approximately 58 min/day (P non-linear = 0.02). Regarding MVPA patterns, the active weekend warrior pattern was inversely associated with bowel resection risk (HR, 0.28; 95% CI, 0.12-0.65), the regularly active pattern was inversely associated with both bowel resection risk (HR, 0.37; 95% CI, 0.19-0.69) and mortality (HR, 0.53; 95% CI, 0.31-0.91) compared to the inactive. Conclusion and relevanceLonger accelerometer-measured MVPA was associated with reduced bowel resection risk and mortality. The regularly active pattern may be the optimal choice for individuals with IBD, while the active weekend warrior pattern still provides health benefits compared to being inactive.

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Clinical equipoise and patient preferences for DOAC resumption after high-risk endoscopy: implications for a randomized trial

Smith, Z. L.; Elmunzer, B. J.; Forbes, N.; Ruff, C. T.; Hills, M. T.; Scholtens, D. M.

2026-08-17 gastroenterology 10.64898/2026.08.14.26360466 medRxiv
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Background Optimal timing for resuming direct oral anticoagulants (DOACs) after high-risk endoscopic procedures remains uncertain, and existing recommendations derive largely from expert opinion. The objective of this study was to characterize practice patterns and perceptions among endoscopists and outcome prioritization among patients with atrial fibrillation, in order to inform the design of the planned RESUME randomized trial. Methods We conducted parallel, cross-sectional surveys of practicing endoscopists and patients with atrial fibrillation using electronic questionnaires administered via Qualtrics. The endoscopist survey, distributed through the American Society for Gastrointestinal Endoscopy, assessed practice patterns, acceptability of early (postoperative day [POD] +1), intermediate (POD +3), and late (POD +5) resumption strategies, and perceptions of clinical equipoise. The patient survey, distributed through two advocacy organizations, assessed perceived confidence in existing guidance and prioritization of bleeding versus thromboembolic risk. Results A total of 201 endoscopists and 477 patients (92.5% taking a DOAC) provided evaluable responses. Endoscopists demonstrated wide variability in preferred timing of DOAC resumption after a standardized high-risk mucosal resection vignette, ranging from same-day resumption to delays beyond five days. POD +2 was the most commonly selected strategy, and most respondents rated more than one proposed RESUME trial arm as acceptable. Nearly all endoscopists (98.9%) rated a randomized trial to determine optimal timing as important. Patient preferences regarding bleeding versus stroke risk were heterogeneous and symmetrically distributed around the neutral response on a five-point ordinal scale. Preferences did not differ by prior stroke or transient ischemic attack, prior major bleeding, age, sex, or geographic region. More than half of patients (54.6%) reported being very or somewhat confident that clear guidance exists regarding DOAC resumption, despite the absence of high-quality randomized evidence informing this question. Conclusions Endoscopists demonstrate substantial practice variability and clinical equipoise, and patients demonstrate heterogeneous and balanced outcome preferences, regarding the timing of DOAC resumption after high-risk endoscopy. These findings support the ethical justification and relevance of the planned RESUME trial.

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Body surface colonic mapping detects meal and bisacodyl-induced colonic motility in patients with chronic constipation

Verheyden, A.; Dinning, P. G.; O'Grady, G.; Tack, J.; Erickson, J. C.

2026-02-10 gastroenterology 10.64898/2026.02.08.26345865 medRxiv
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Chronic constipation is highly prevalent, and cases refractory to treatment are particularly challenging to manage. High-resolution colonic manometry (HRM) is used to further evaluate these patients to identify cases of intrinsic motor dysfunction (underlying myopathy or neuropathy). However, HRM is invasive and resource-intensive, limiting uptake and clinical utility. This study presents Body Surface Colonic Mapping (BSCM), a non-invasive cutaneous electrical recording technique, as a clinical alternative. Simultaneous recordings from HRM (36-channel) and BSCM (8x8 electrode array) were performed in 10 patients with chronic refractory constipation. Lower gut symptom scores were also tracked patients over the duration of the recording. Motility was assessed during meal and bisacodyl challenges. We optimized BSCM signal processing specifically to detect high-amplitude propagating contractions (HAPCs) evoked by bisacodyl. Analysis included time-frequency quantification of motility indices and blinded visual assessment by domain experts to classify the presence or absence of motor responses. BSCM motility indices showed strong correlation with HRM for both meal (r = 0.86) and bisacodyl (r = 0.69) responses. Expert visual analysis yielded concordant classification between BSCM and HRM in the majority (87.5 {+/-} 9.6%) of cases. Furthermore, BSCM identified distinct, patient-specific symptom-motility associations during the meal response. BSCM accurately detects meal- and stimulant-induced increases in colonic motility with high fidelity to invasive HRM. As a non-invasive method that is easy to apply with minimal resource and time requirements, BSCM is well-positioned for clinical translation as a scalable diagnostic tool to elucidate symptom-motility associations and guide personalized management in refractory chronic constipation.

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An Updated Meta-analysis of Studies Comparing Conventional to Underwater Endoscopic Mucosal Resection for Colorectal Polyps

Pamarthy, R.; Ali, H.; Waqar, S. H.

2022-05-21 gastroenterology 10.1101/2022.05.17.22275225 medRxiv
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BackgroundUnderwater endoscopic mucosal resection (UEMR) is an emerging alternative to conventional endoscopic mucosal resection (CEMR). We intended to compare both techniques for colorectal polyp resection. MethodsA comprehensive search of several databases to identify studies published until November 2021 was performed. Inclusion criteria included studies comparing UEMR to CEMR in adult patients. The calculation was done by standard meta-analysis methodology, and heterogeneity was assessed using the I2% statistics. Results1029 polyps were resected with the CEMR technique and 1078 polyps with UEMR. UEMR was associated with an increase in the rate of overall en-bloc resection (Odds ratios (OR) 1.77; 95% CI, 1.42-2.22; P < .0001; I2 = 20%). Subgroup analysis showed an increase in the rates of en-bloc resection in polyps greater than 20 mm (OR 1.62; 95% CI, 1.17-2.25; P = 0.004; I2 = 33%). There was a reduction in the recurrence rate of polyps (P < 0.0001) in the UEMR cohort. Post-procedural bleeding or risk of perforation was not increased in either group. Resection times were shorter in UEMR (Mean difference, -8.09; P = 0.006). ConclusionUEMR is associated with lower recurrence rates and shorter procedure duration. In the future, UEMR may become the standard technique for colorectal polypectomy.

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Colonoscopy Complications in Persons with Spinal Cord Injury - worth the risk?

Trbovich, M. E.; McLaughlin, A.; Anthony, C.; Koek, W.; Camero, A.; Gowen, L.; Burau, K.

2025-12-23 gastroenterology 10.64898/2025.12.19.25342693 medRxiv
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ObjectivePrevalence of anemia in persons with spinal cord injury is higher than their able-bodied counterparts at 50-80%. The etiology is multifactorial but likely related to chronic whole-body inflammation. Chronic anemia is often an indication of gastrointestinal blood loss leading to a diagnostic colonoscopy. However, colonoscopies in persons with spinal cord injury are not without complications. We tested the hypothesis that, despite a high incidence of anemia, performing a colonoscopy in persons with spinal cord injury has a high complication rate and low rate of finding high risk pathology. DesignRetrospective chart review Subjects41 persons with chronic spinal cord injury admitted for colonoscopy from 2019-2024. MethodsPercent of complications and abnormal findings were calculated. A logistic regression model determined predictors of complications and abnormal findings. ResultsAnemia prevalence was 59.1% with a complication rate of 38.6% and 59 abnormal findings in 95.2% of CSPs (n=4 (6.8%), high-risk pathology). Persons with anemia had a higher risk of complications and a decreased risk of hemorrhoids. ConclusionIn persons with spinal cord injury, given a low-rate high risk pathology in the setting of a high complication rate, especially in persons with anemia, the risk of complications should be weighed more heavily in the decision to perform a colonoscopy.

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Preference for Blood-Based Colorectal Cancer Screening in the Black Community

Li, R.; Jackson, T. M.; Onyekaba, J.; He, Y.; Njoku, K.; Amadi, C.; Chandora, A.; Santori, D. O.; Gundroo, H.; Tobun, T.; Smith, C.; Hommes, D.; Luevano, J.; Liu, J.

2026-07-24 gastroenterology 10.64898/2026.07.22.26358691 medRxiv
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Background: Blood-based colorectal cancer (CRC) screening is a novel, less invasive screening that has the potential to improve CRC screening adherence, particularly among Black American populations, which has historically lower screening rates. We evaluated factors associated with preference for blood-based CRC screening among Black adults in church-based community settings. Methods: From October 2023 to January 2024, a cross-sectional survey was conducted over 101 adults aged 45 to 75 years at three Black churches in metropolitan Atlanta, Georgia. Demographics, CRC screening history, healthcare access, and attitudes toward blood-based CRC screening were assessed. Results: Overall, 72 participants (71.3%) preferred blood-based CRC screening. Preference was not associated with demographic or socioeconomic characteristics, screening history, or healthcare access. The most commonly reported reasons for ease of testing (83.3%), avoidance of stool collection (38.9%), avoidance of bowel preparation (36.1%), perceived fewer side effects (34.7%), and perceived lower risk (33.3%). Needle concerns were the only factor significantly associated with non-preference (p=0.034). Conclusion: Blood-based colorectal cancer screening was preferred by most Black adults and may improve CRC screening participation through greater convenience.