An 'Adaptive Treatment Strategy' for Oral Vancomycin in Patients with the Orphan Disease Primary Sclerosing Cholangitis.

Decision-making in clinical medicine ideally is based upon evidence from randomized, placebo-controlled trials (RCTs) and subsequent systematic reviews and meta-analyses. However, for orphan diseases, the expectation of having one or multiple RCTs that inform clinical guidelines or justify specific treatments can be unrealistic and subsequent therapeutic nihilism can be detrimental to patients. This article discusses the benefits of therapeutic decision-making in the context of orphan diseases, focusing on primary sclerosing cholangitis (PSC) as an example of an orphan disease with poor clinical outcomes. PSC is a rare disorder characterized by inflammation and progressive fibrosis of the bile ducts. It carries a high risk of liver failure, malignancies, and debilitating symptoms that impair quality of life. Liver transplantation is currently the only life-prolonging intervention for PSC, but it is not a curative option. The article highlights the potential benefits of treating PSC patients with oral vancomycin (OV), which has shown significant clinical responses and improved quality of life in some cases. However, access to OV therapy is limited due to the lack of RCTs supporting its use. The standard requirement of having evidence from RCTs may result in withholding potentially life-altering and/or life-saving treatments for patients with orphan diseases. Conducting RCTs is challenging in these patient populations due to difficulties in recruiting the required patient cohorts and limited commercial returns. A standardized 'adaptive treatment strategy' is proposed to address this. This approach leverages the best available evidence for specific treatments, considers individual clinical responses, and adjusts treatment over time.

Validation of a Machine Learning Algorithm, EVendo, for Predicting Esophageal Varices in Hepatocellular Carcinoma.

BACKGROUND: Treatment with atezolizumab and bevacizumab has become standard of care for advanced unresectable hepatocellular carcinoma (HCC) but carries an increased gastrointestinal bleeding risk. Therefore, patients are often required to undergo esophagogastroduodenoscopy (EGD) to rule out esophageal varices (EV) prior to initiating therapy, which can delay care and lead to unnecessary procedural risks and health care costs. In 2019, the EVendo score was created and validated as a noninvasive tool to accurately screen out patients who were at low risk for having EV that required treatment. We sought to validate whether the EVendo score could be used to accurately predict the presence of EV and varices needing treatment (VNT) in patients with HCC. METHODS: This was a retrospective multicenter cohort study of patients with HCC from 9/2004 to 12/2021. We included patients who underwent EGDs within 1 year after their HCC diagnosis. We collected clinical parameters needed to calculate an EVendo score at the time of EGD and compared the EVendo model prediction to the gold standard endoscopic report in predicting presence of VNT. RESULTS: 112 with HCC were recruited to this study, with 117 qualifying EGDs. VNT occurred in 39 (33.3%) patients. The EVendo score had a sensitivity of 97.4% and a negative predictive value of 96.9%, supporting the validity in applying EVendo in predicting VNT in HCC. CONCLUSION: In this study, we validated the use of the EVendo score in ruling out VNT in patients with HCC. The application of the EVendo score could safely defer about 30% of EGDs for EV screening in HCC patients. Although additional validation cohorts are needed, this suggests that EVendo score can potentially be applied in patients with HCC to avoid unnecessary EGDs, which can ultimately mitigate healthcare costs and delays in initiating HCC treatment with atezolizumab and bevacizumab.

Efficacy and safety of biologics in primary sclerosing cholangitis with inflammatory bowel disease: A systematic review and meta-analysis.

BACKGROUND: Primary sclerosing cholangitis (PSC) is an immune-mediated, chronic cholestatic liver disease. Currently, liver transplantation is the only established life-saving treatment. Several studies have evaluated the effect of different biologic therapies on PSC with inconclusive findings. We conducted a systematic review and meta-analysis to assess the effects of biologics in PSC and associated inflammatory bowel disease (IBD). METHODS: MEDLINE, Scopus, and Embase were searched up to July 31, 2023, for studies reporting the effects of biologics in patients with PSC-IBD. Effects of biologic therapy on alkaline phosphatase, total bilirubin, ulcerative colitis response score, and adverse events were calculated and expressed as standardized difference of means (SMD), proportions, and 95% CI using a random-effects model. RESULTS: Six studies, including 411 PSC-IBD patients who received biologics, were included. Biologic treatment was associated with no change in alkaline phosphatase (SMD: 0.1, 95% CI: -0.07 -0.17, p=0.43), but a small and statistically significant increase in total bilirubin (SMD: 0.2, 95% CI: 0.05-0.35, p<0.01). 31.2% (95% CI: 23.8-39.7) of patients with IBD achieved endoscopic response, and there was a significant improvement in ulcerative colitis response score (SMD: -0.6,95% CI: -0.88 to 0.36, p<0.01). Furthermore, 17.6% (95% CI: 13.0-23.5) of patients experienced adverse events severe enough to discontinue therapy, and 29.9% (95% CI: 25.2-34.8) had a loss of response to biologics. CONCLUSIONS: Treatment of patients with PSC-IBD with biologics (vedolizumab, infliximab, and adalimumab) was not associated with improvement of biochemical markers of cholestasis. Biologics are effective in treating the colitis associated with PSC. Vedolizumab was associated with worsening liver enzymes in contrast to other biologics, a finding that warrants further study.

Leveraging telemedicine in gastroenterology and hepatology: a narrative review.

Background and Objective: Over the years, telemedicine has played a prominent role in delivering healthcare to patients. Due to its flexibility and many benefits, telemedicine confers physicians the ability to guide and promote medical care remotely. The advent of the coronavirus disease 2019 (COVID-19) pandemic has changed the landscape of medicine and has accelerated the usage of digital and remote healthcare systems for clinical care. Herein, we provide an overview of telemedicine, its applications in managing inflammatory bowel disease (IBD), celiac disease (CD), and liver diseases, its advantages and limitations, and its use in educating the next generation of gastroenterologists. Methods: We conducted a review of scientific articles published in PubMed and Google Scholar. Articles were selected based on the search terms included in the search strategy summary. The language of the articles was restricted to English only. Key Content and Findings: We report that telemedicine has the potential to streamline and improve patient care in gastroenterology (GI) and hepatology while also limiting health care expenses. Additionally, we noted the importance of tele-education for training the next generation of physicians who intend on practicing in rural settings. Furthermore, we identified barriers to telemedicine care that exacerbate health inequities and potential solutions to achieving digital health equity. Lastly, we briefly discuss the role of artificial intelligence (AI) in remote patient monitoring. Conclusions: Although telemedicine has existed for many decades, over the past decade there have been many advancements in telemedicine applications in GI and hepatology. Despite its broad benefits, further research needs to be done to alleviate barriers to telemedicine care.

Best Practices in Esophageal, Gastroduodenal, and Colonic Stenting.

Endoscopic stenting is an area of endoscopy that has witnessed noteworthy advancements over the last decade, resulting in evolving clinical practices among gastroenterologists around the world. Indications for endoscopic stenting have progressively expanded, becoming a frequent part of the management algorithm for various benign and malignant conditions of the gastrointestinal tract, from esophagus to rectum. In addition to expanded indications, continuous technological enhancements and development of novel endoscopic stents have resulted in an increased success of these approaches and, in some cases, allowed new applications. This review aimed to summarize best practices in esophageal, gastroduodenal, and colonic stenting.

A colocação de próteses endoscópicas é uma técnica que tem testemunhado avanços notáveis na última década, resultando na evolução da prática clínica diária dos gastroenterologistas em todo o mundo. As indicações para a colocação de próteses endoscópicas têm expandido progressivamente, tornando-se uma opção cada vez mais frequente no algoritmo de abordagem das mais variadas condições benignas e malignas do trato gastrointestinal (desde o esófago ao reto). Além da expansão nas indicações, o aprimoramento tecnológico contínuo e o desenvolvimento de novas próteses endoscópicos resultaram num maior sucesso dessas abordagens e, em alguns casos, permitiram novas aplicações. Esta revisão tem como objetivo resumir as melhores práticas em colocação de próteses endoscópicas esofágicas, gastroduodenais e colorretais.

Clinical outcomes and learning curve for ERCP during advanced endoscopy training: a comparison of supine versus prone positioning.

BACKGROUND AND AIMS: No studies have evaluated trainees' outcomes when learning ERCP with patients in the supine and prone positions simultaneously. We aimed to assess whether patient position impacts procedural outcomes and learning curve. METHODS: We prospectively evaluated patients undergoing ERCP by a supervised advanced endoscopy trainee (AET) at a tertiary care center. Adult patients with native papillae were included. The AET was universally given 5 attempts per cannulation. Outcomes were evaluated quarterly. RESULTS: Successful cannulation was achieved in 44 supine (69%) and 17 prone (68%) patients (P = .95). Although mean time to reach the papilla was shorter in the supine patient position, time to biliary cannulation (7.8 vs 9.4 minutes, P = .53) and number of attempts were similar. A stepwise increase was seen in cannulation rates throughout the academic year (P < .01) and increased more in supine patients (P = .01). Procedure and total room times were shorter in supine patients. CONCLUSIONS: Shorter procedure and room turnover times and a comparable cannulation rate were found for supine versus prone ERCP.

Clinical epidemiology and outcomes of patients with gastric intestinal metaplasia in the Los Angeles County System.

BACKGROUND: Gastric intestinal metaplasia (GIM) is a precursor to gastric adenocarcinoma (GAC). In the United States, there is no consensus on the utility of surveillance for GIM, and minority populations most affected by GAC are understudied. Our aims were to define clinical and endoscopic features, surveillance practices, and outcomes in patients with GIM in a multicenter safety-net system. METHODS: We identified patients with biopsy-proven GIM between 2016-2020 at the three medical centers comprising Los Angeles County Department of Health Services. Demographics, findings at index esophagogastroduodenoscopy (EGD) first showing GIM, recommended interval for repeat EGD, and findings at repeat EGD were abstracted. Descriptive statistics were performed to characterize our cohort. T-tests and chi-squared (χ2) tests were used to compare patients with and without multifocal GIM. RESULTS: There were 342 patients with newly-diagnosed biopsy-proven GIM, 18 (5.2%) of whom had GAC at index EGD. Hispanic patients comprised 71.8% of patients. For most patients (59%), repeat EGD was not recommended. If recommended, 2-3 years was the most common interval. During a median time to repeat EGD of 13 months and cumulative follow-up of 119 patient-years, 29.5% of patients underwent at least one repeat EGD, of whom 14% had multifocal GIM not previously detected. Progression to dysplasia or GAC was not detected in any patients. CONCLUSION: In a predominantly minority population with biopsy-proven GIM, there was a 5% incidence of GAC on index EGD. Though progression to neither dysplasia nor GAC was detected, there was significant variability in endoscopic sampling and surveillance practices.

Relationships of hospitalization outcomes and timing to endoscopy in non-variceal upper gastrointestinal bleeding: A nationwide analysis.

BACKGROUND: The optimal timing of esophagogastroduodenoscopy (EGD) and the impact of clinico-demographic factors on hospitalization outcomes in non-variceal upper gastrointestinal bleeding (NVUGIB) remains an area of active research. AIM: To identify independent predictors of outcomes in patients with NVUGIB, with a particular focus on EGD timing, anticoagulation (AC) status, and demographic features. METHODS: A retrospective analysis of adult patients with NVUGIB from 2009 to 2014 was performed using validated ICD-9 codes from the National Inpatient Sample database. Patients were stratified by EGD timing relative to hospital admission (≤ 24 h, 24-48 h, 48-72 h, and > 72 h) and then by AC status (yes/no). The primary outcome was all-cause inpatient mortality. Secondary outcomes included healthcare usage. RESULTS: Of the 1082516 patients admitted for NVUGIB, 553186 (51.1%) underwent EGD. The mean time to EGD was 52.8 h. Early (< 24 h from admission) EGD was associated with significantly decreased mortality, less frequent intensive care unit admission, shorter length of hospital stays, lower hospital costs, and an increased likelihood of discharge to home (all with P < 0.001). AC status was not associated with mortality among patients who underwent early EGD (aOR 0.88, P = 0.193). Male sex (OR 1.30) and Hispanic (OR 1.10) or Asian (aOR 1.38) race were also independent predictors of adverse hospitalization outcomes in NVUGIB. CONCLUSION: Based on this large, nationwide study, early EGD in NVUGIB is associated with lower mortality and decreased healthcare usage, irrespective of AC status. These findings may help guide clinical management and would benefit from prospective validation.

The effects of liraglutide on liver enzymes and metabolic factors in patients with nonalcoholic steatohepatitis: a meta-analysis of randomized controlled trials.

Introduction: Nonalcoholic steatohepatitis (NASH) is the most common cause of chronic liver disease, but no drug therapies have been approved to date. While glucagon-like peptide-1 (GLP-1) analogues may help in the management, the existing evidence remains conflicting. Aim: This meta-analysis aims to elucidate the efficacy of liraglutide in patients with NASH. Material and methods: We searched 4 databases for randomized controlled trials assessing the efficacy of liraglutide in patients with NASH. We analysed continuous outcomes using the mean difference (MD) and relative 95% confidence interval (CI), while dichotomous outcomes were analysed using the risk ratio (RR) and relative 95% CI. Primary endpoints included alanine aminotransferase (ALT) (IU/l), aspartate aminotransferase (AST) (IU/l), alkaline phosphatase (ALP) (IU/l), and γ-glutamyl transferase (GGT) (IU/l). Secondary outcomes were body mass index (BMI) (kg/m2), waist circumference (cm), total cholesterol (TC) (mmol/l), triglyceride (TG) (mmoll), high-density lipoprotein (HDL) (mmol/l), low-density lipoprotein (LDL) (mmol/l), and glycated hemoglobin (HbA1c) (%). Results: A total of 5 clinical trials were included. The analysis showed that liraglutide is effective in increasing HDL (MD = +0.10 (-0.18, -0.02), p = 0.02) and reducing LDL levels in blood (MD = -0.29 (-0.56, -0.02), p = 0.04). No significant difference was noted in levels of ALT (MD = 2.66 (-1.56, 6.87), p = 0.22), AST (MD = -1.99 (-5.70, 1.72), p = 0.29), GGT (MD = 5.02 (-0.86, 10.90), p = 0.09), ALP (MD = -5.16 (-11.90, 1.59), p = 0.13), TC (MD = -0.31 (-0.65, 0.03), p = 0.07), or TG (MD = -0.14 (-0.53, 0.25), p = 0.48). The HbA1c (%) level was found to be significantly reduced in the liraglutide arm (MD = -0.62 (-0.88, -0.36), p < 0.01). Conclusions: Liraglutide effectively improves the lipid profile in patients with NASH.

Clinical Features and Outcomes of Patients with Pancreaticobiliary Malignancies in Los Angeles County and Their Association with CA 19-9 Levels.

Although CA 19-9 is a commonly used tumor marker in the management of PBMs, the literature describing outcomes in patients with PBMs who have undetectable or low (hereinafter "low") CA 19-9 levels remains scarce. In this study, we sought to compare clinical features and outcomes in patients with PBMs and low CA 19-9 levels to those with normal and elevated CA 19-9 levels. METHODS: We retrospectively collected data on patients with biopsy-confirmed PBMs and stratified patients into categories based on their CA 19-9 level at diagnosis. Survival curves were estimated for patients in each of the three aforementioned CA 19-9 groups using the Kaplan-Meier method and compared using a Cox proportional hazards regression model. RESULTS: Of the 283 patients identified, 23 (8.1%) had low, 70 (24.7%) had normal, and 190 (67.1%) had elevated CA 19-9 levels. After controlling for sex, age, BMI, the presence of metastases at the time of diagnosis, and treatment with curative intent, the hazard ratio for death in the elevated CA 19-9 group compared to the low CA 19-9 group was 1.993 (95% CI 1.089-3.648; p = 0.025). CONCLUSION: The elevated CA 19-9 level compared to the low CA 19-9 level and the presence of metastases were associated with an increased hazard of death, while treatment with curative intent was associated with a decreased hazard of death.

The role and timing of endoscopic retrograde cholangiopancreatography in acute biliary pancreatitis without cholangitis: A nationwide analysis.

BACKGROUND/PURPOSE: The role and optimal timing of endoscopic retrograde cholangiopancreatography (ERCP) in acute biliary pancreatitis without cholangitis (ABPwoC) remains unclear. Using a large national database, we aimed to examine hospitalization outcomes of patients with ABPwoC as a function of the performance and timing of ERCP. METHODS: This was a retrospective study of adult patients with ABPwoC utilizing the National Inpatient Sample from 2016-2017. Patients who underwent inpatient ERCP were stratified into performance: within 24, 24-48, 48-72, and >72 h of hospital admission. The primary outcome was all-cause inpatient mortality as a function of the performance and timing of ERCP; secondary outcomes, including healthcare utilization, were assessed. Multivariate modeling was used to adjust for potential confounders. Statistical analyses were conducted using STATA, version 16.0. RESULTS: Of the 70 030 patients with ABPwoC, 31.37% underwent inpatient ERCP. Performance (aOR: 0.6, p < .05), but not timing (aOR: 0.98, p = .9), of inpatient ERCP was associated with significantly lower all-cause inpatient mortality. Urgent ERCP (within 24 h) was associated with shorter hospital length of stay, lower charges and cost, and less need for pancreatic drainage procedures, while ERCP within 72 h was associated with less frequent intensive care unit admission (all p < .05). DISCUSSION: Based on this large, nationwide analysis, inpatient ERCP for ABPwoC is associated with lower all-cause mortality. ERCP within 24 and 72 h, though not associated with lower mortality, are associated with multiple improved clinical outcomes, including lower healthcare charges and costs.

Best Practices in Pancreatico-biliary Stenting and EUS-guided Drainage.

Indications for endoscopic placement of endoluminal and transluminal stents have greatly expanded over time. Endoscopic stent placement is now a well-established approach for the treatment of benign and malignant biliary and pancreatic diseases (ie, obstructive jaundice, intra-abdominal fluid collections, chronic pancreatitis etc.). Ongoing refinement of technical approaches and development of novel stents is increasing the applicability and success of pancreatico-biliary stenting. In this review, we discuss the important developments in the field of pancreatico-biliary stenting, with a specific focus on endoscopic retrograde cholangiopancreatography and endoscopic ultrasound-associated developments.

Yield of Post-Acute Diverticulitis Colonoscopy for Ruling Out Colorectal Cancer.

Background and Aims: Colonoscopy is recommended post-acute diverticulitis (AD) to exclude underlying adenocarcinoma (CRC). However, post-AD colonoscopy utility remains controversial. We aimed to examine yield of post-AD colonoscopy in our majority-Hispanic patient population. Methods: Patients undergoing post-AD colonoscopy between 11/1/2015-7/31/2021 were identified from a prospectively maintained endoscopic database. AD cases without computed tomography confirmation were excluded. Pertinent data, including complicated vs uncomplicated AD, fecal immunochemical test (FIT) result post-AD/pre-colonoscopy, and number/type/location of non-advanced adenomas, advanced adenomas, and CRC, were abstracted. Analyses were conducted using two-sample Wilcoxon rank-sum and Fisher's exact tests. Results: 208 patients were included, of whom 62.0% had uncomplicated AD. Median age was 53, 54.3% were female, and 77.4% were Hispanic. Ninety non-advanced adenomas were detected in 45 patients (21.6%), in addition to advanced adenoma in eight patients (3.8%). Two patients (1.0%) had CRC, both of whom had complicated AD in the same location seen on imaging, and one of whom was FIT+ (the other had not undergone FIT). Patients with uncomplicated versus complicated AD had similarly low rates of advanced adenomas (4.7% vs. 2.5%, p=0.713). FIT data were available in 51 patients and positive in three (5.9%); non-advanced adenomas were found in all three FIT+ patients. No FIT- patient had an advanced adenoma or CRC. Conclusion: Colonoscopy post-AD is generally low yield, with CRC being rare and found only in those with complicated AD. Colonoscopy post-complicated AD appears advisable, whereas less invasive testing (e.g. FIT) may be considered post-uncomplicated AD to inform the need for colonoscopy.

Diversity, equity, and inclusion in gastroenterology and hepatology: a survey of where we stand.

BACKGROUND & AIMS: In the setting of increasing attention to representation in medicine, we aimed to assess current perspectives of racial and ethnic workforce diversity and health care disparities among gastroenterology (GI) and hepatology professionals in the United States. METHODS: We developed and administered a 33-item electronic cross-sectional survey to members of 5 national GI and hepatology societies. Survey items were organized into thematic modules and solicited perspectives on racial and ethnic workforce diversity, health care disparities in GI and hepatology, and potential interventions to enhance workforce diversity and improve health equity. RESULTS: Of the 1219 survey participants, 62.3% were male, 48.7% were non-Hispanic White, and 19.9% were from backgrounds underrepresented in medicine. The most frequently reported barriers to increasing racial and ethnic diversity in GI and hepatology were insufficient representation of underrepresented racial and ethnic minority groups in the education and training pipeline (n = 431 [35.4%]), in professional leadership (n = 340 [27.9%]), and among practicing GI and hepatology professionals (n = 324 [26.6%]). Suggested interventions were to increase career mentorship opportunities (n = 545 [44.7%]), medical student opportunities (n = 520 [42.7%]), and program and professional society leadership roles for underrepresented racial and ethnic minority groups (n = 473 [38.8%]). CONCLUSIONS: Our survey explored imperative and timely perspectives on racial and ethnic representation and health equity among professionals in GI and hepatology. The findings should inform future interventions to address workforce diversity and establish priorities toward improving health equity, ultimately serving as a springboard for professional societies, academic institutions, and other organizations that aim to increase diversity, equity, and inclusion in our field.

Diversity, Equity, and Inclusion in Gastroenterology and Hepatology: A Survey of Where We Stand.

BACKGROUND & AIMS: In the setting of increasing attention to representation in medicine, we aimed to assess current perspectives of racial and ethnic workforce diversity and health care disparities among gastroenterology (GI) and hepatology professionals in the United States. METHODS: We developed and administered a 33-item electronic cross-sectional survey to members of 5 national GI and hepatology societies. Survey items were organized into thematic modules and solicited perspectives on racial and ethnic workforce diversity, health care disparities in GI and hepatology, and potential interventions to enhance workforce diversity and improve health equity. RESULTS: Of the 1219 survey participants, 62.3% were male, 48.7% were non-Hispanic White, and 19.9% were from backgrounds underrepresented in medicine. The most frequently reported barriers to increasing racial and ethnic diversity in GI and hepatology were insufficient representation of underrepresented racial and ethnic minority groups in the education and training pipeline (n = 431 [35.4%]), in professional leadership (n = 340 [27.9%]), and among practicing GI and hepatology professionals (n = 324 [26.6%]). Suggested interventions were to increase career mentorship opportunities (n = 545 [44.7%]), medical student opportunities (n = 520 [42.7%]), and program and professional society leadership roles for underrepresented racial and ethnic minority groups (n = 473 [38.8%]). CONCLUSIONS: Our survey explored imperative and timely perspectives on racial and ethnic representation and health equity among professionals in GI and hepatology. The findings should inform future interventions to address workforce diversity and establish priorities toward improving health equity, ultimately serving as a springboard for professional societies, academic institutions, and other organizations that aim to increase diversity, equity, and inclusion in our field.

Diversity, equity, and inclusion in gastroenterology and hepatology: A survey of where we stand.

BACKGROUND AND AIMS: In the setting of increasing attention to representation in medicine, we aimed to assess current perspectives of racial and ethnic workforce diversity and health care disparities among gastroenterology (GI) and hepatology professionals in the United States. APPROACH AND RESULTS: We developed and administered a 33-item electronic cross-sectional survey to members of five national GI and hepatology societies. Survey items were organized into thematic modules and solicited perspectives on racial and ethnic workforce diversity, health care disparities in GI and hepatology, and potential interventions to enhance workforce diversity and improve health equity. Of the 1219 survey participants, 62.3% were male, 48.7% were non-Hispanic White, and 19.9% were from backgrounds underrepresented in medicine. The most frequently reported barriers to increasing racial and ethnic diversity in GI and hepatology were insufficient representation of underrepresented racial and ethnic minority groups in the education and training pipeline (n = 431 [35.4%]), in professional leadership (n = 340 [27.9%]), and among practicing GI and hepatology professionals (n = 324 [26.6%]). Suggested interventions were to increase career mentorship opportunities (n = 545 [44.7%]), medical student opportunities (n = 520 [42.7%]), and program and professional society leadership roles for underrepresented racial and ethnic minority groups (n = 473 [38.8%]). CONCLUSIONS: Our survey explored imperative and timely perspectives on racial and ethnic representation and health equity among professionals in GI and hepatology. The findings should inform future interventions to address workforce diversity and establish priorities toward improving health equity, ultimately serving as a springboard for professional societies, academic institutions, and other organizations that aim to increase diversity, equity, and inclusion in our field.