A Comprehensive Analysis of Reported Adverse Events and Device Failures Associated with Esophageal Self-Expandable Metal Stents: An FDA MAUDE Database Study.

INTRODUCTION: Esophageal Stents are used to maintain esophageal lumen patency in esophageal strictures caused by intrinsic and/or extrinsic malignancies and the occlusion of concomitant esophageal fistulas. While data on the efficacy and safety of esophageal stents exist, comprehensive evaluation of adverse events is limited. The aim of this study is to investigate the reported adverse events and device failures associated with esophageal self-expandable metal stents (SEMS) using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: Post-marketing surveillance data for the esophageal SEMSs were analyzed using the FDA's MAUDE database from January 2014 to December 10, 2023. The outcomes of interest were patient-related adverse events and device failures. Statistical analysis was performed using Microsoft Excel 2010 and SPSS. Pooled numbers and percentages were calculated for each adverse event. Continuous variables underwent analysis using a two-tailed student t test, and significance was set to p ≤ 0.05. RESULTS: During the study period, 548 MAUDE reports revealed 873 device failures and 186 patient-related adverse events. The most common device issues were stent activation, positioning, or separation problems (4 n = 403; 46.2%), followed by device detachment or migration (n = 109, 12.5%), and material problems (n = 93, 10.7%). Patient complications included dysphagia/odynophagia (10%), perforation, pain, and bleeding (each 7.6%). The most common device failures in over-the-wire (OTW) stents and through-the-scope (TTS) stents were activation, positioning, or separation problems (TTS: n = 183, 52.6% vs OTW: n = 220, 41.9%). Compared to OTW stents, TTS stents had higher migration and breakage (13.5% vs. 11.8%, p = 0.24), and (9.2% vs. 6.7%, p = 0.08) respectively, while OTW stents had more challenges with stent advancement or removal (5.1% vs. 0.3%, p < 0.001 and 4.6% vs 3.4%, p = 0.19, respectively) and material problems (14.7% vs. 4.6%, p < 0.001). Activation, positioning, and separation problems were the most frequent device failures in fully covered (FC) and partially covered (PC) stents (FC: n = 62, 32.8%, PC: n = 168, 43.5%). FC stents had higher migration rates (20.6% vs 9.8%, p < 0.001), while PC stents exhibited more material problems (17.4% vs. 5.8%, p < 0.001) and difficulties with advancing the stents (6.7% vs. 0%, p < 0.001). CONCLUSION: Our examination showed a prevalence of reported device complications associated with stent activation, positioning, and separation problems. Dysphagia or odynophagia emerged as the most frequently reported patient complication. Furthermore, our analysis, provides insights into TTS vs. OTW and FC vs. PC esophageal SEMSs, enabling endoscopists and manufacturers to better understand adverse events and potentially optimize device design for future iterations.

Endoscopic closure of pancreatico-colonic fistulas in a patient with persistent infected pancreatic necrosis and bacteremia.

Video 1Pancreatico-colonic fistula closure.

The National Burden of Colorectal Cancer in the United States from 1990 to 2019.

CRC accounts for approximately a tenth of all cancer cases and deaths in the US. Due to large differences in demographics among the different states, we aim to determine trends in the CRC epidemiology and across different states, age groups, and genders. CRC rates, age-adjusted to the standard US population, were obtained from the GBD 2019 database. Time trends were estimated as annual percentage change (APC). A pairwise comparison was conducted between age- and gender-specific trends using the tests of parallelism and coincidence. Age-specific trends were also assessed in two age subgroups: younger adults aged 15-49 years and older adults aged 50-74 years. We also analyzed the prevalence, incidence, mortality, and DALYs in the US between 1990 and 2019. A total of 5.53 million patients were diagnosed with CRC in the US between 1990 and 2019. Overall, CRC incidence rates have significantly increased in younger adults (11.1 per 100,000 persons) and decreased in older adults (136.8 per 100,000 persons) (AAPC = 1.2 vs. -0.6; AAPC difference = 1.8, p < 0.001). Age-specific trends were neither identical (p < 0.001) nor parallel (p < 0.001), suggesting that CRC incidence rates are different and increasing at a greater rate in younger adults compared to older adults. However, for both men and women (49.4 and 35.2 per 100,000 persons), incidence rates have decreased over the past three decades at the same rate (AAPC = -0.5 vs. -0.5; AAPC difference = 0, p = 0.1). Geographically, the southern states had the highest mortality rates with Mississippi having the highest rate of 20.1 cases per 100,000 population in 2019. Massachusetts, New York, and the District of Colombia had the greatest decreases in mortality over the study period (-42.1%, -41.4%, and -40.9%). Decreased mortality was found in all states except Mississippi, where the mortality of CRC increased over the study period (+1.5%). This research provides crucial insights for policymakers to tailor resource allocation, emphasizing the dynamic nature of CRC burden across states and age groups, ultimately informing targeted strategies for prevention and intervention.

Cannabis use and cyclical vomiting syndrome: An open debate.

INTRODUCTION: Cyclical vomiting syndrome (CVS) carries a significant financial burden on the U.S. healthcare system due to the recurrent emergency department visits and inpatient hospitalizations. We aimed to update the literature on the predictors of hospital utilization and readmission among individuals admitted with CVS. METHODS: This is a retrospective nationwide study of patients hospitalized with a primary diagnosis of CVS. Using weighted data from the National Inpatient Sample (NIS) and the National Readmission Database (NRD), we conducted a multivariate regression analysis to assess predictors of length of stay (LOS), and 30-day readmission. RESULTS: Primary admissions for CVS totaled 35,055 in the NIS, and 31,240 in the NRD. 2012 patients (6.4%) were readmitted within 30 days. On multivariate regression, cannabis use was associated with reduced LOS (adjusted Mean Difference (aMD) = -0.53 days, 95% CI: -0.68 to -0.38), and 30-day readmissions (adjusted Hazard Ratio (aHR) = 0.63, 95% CI: 0.54-0.73). DISCUSSION: Cannabis use among CVS admissions was associated with reduced LOS and 30-day readmissions; these results could be in fact driven by Cannabis Hyperemesis Syndrome (CHS)-related hospitalizations and the effect of cannabis cessation on decreased symptomatology. ICD-10 coding for CHS should be transitioned to specific codes to improve the differentiation between CVS and CHS-related hospitalizations.

Career selection trends among recent gastroenterology fellowship graduates.

Various career paths exist for gastroenterology (GI) fellowship graduates across the country. These include further training, clinical or nonclinical job opportunities. Clinical career paths for those seeking jobs include academic positions or nonacademic positions (nonacademic hospital employed and private practice jobs). Data regarding career placement trends are limited. This study aims to explore temporal trends in career selection among new GI graduates. This is an observational cohort study. A list of GI fellowship programs was obtained from the FREIDA American Medical Association database. Programs with sufficient information on past graduate or alumni career placement after fellowship between 2017 and 2022 were included. Baseline characteristics and relevant information were collected. A Chi-square test was performed to assess the relationship between the categorical variables. A total of 203 GI fellowship programs were reviewed, among which only 21% (43/203) reported sufficient graduate career information. Across the 43 programs, 636 graduates were included. Thirty-three percent (210/636) of graduates were female. Forty-eight percent (308/636) of the graduates pursued nonacademic positions (nonacademic hospital employed and private practice jobs), 34% (216/636) into academic positions, and 17% (112/636) elected to do additional fellowship training. Both males and females were more likely to be employed in private practice (X2 = 12.8, df = 2, P = .002). Navigating through the decision-making process of selecting the first job after fellowship can be challenging. Our study reveals higher preference for nonacademic roles among graduates, consistent over 5 years, suggesting need to explore obstacles for academic positions or further training.

A Gastroenterologist's Guide to Care Transitions in Cystic Fibrosis from Pediatrics to Adult Care.

Cystic Fibrosis is a chronic disease affecting multiple systems, including the GI tract. Clinical manifestation in patients can start as early as infancy and vary across different age groups. With the advent of new, highly effective modulators, the life expectancy of PwCF has improved significantly. Various GI aspects of CF care, such as nutrition, are linked to an overall improvement in morbidity, lung function and the quality of life of PwCF. The variable clinical presentations and management of GI diseases in pediatrics and adults with CF should be recognized. Therefore, it is necessary to ensure efficient transfer of information between pediatric and adult providers for proper continuity of management and coordination of care at the time of transition. The transition of care is a challenging process for both patients and providers and currently there are no specific tools for GI providers to help ensure a smooth transition. In this review, we aim to highlight the crucial features of GI care at the time of transition and provide a checklist that can assist in ensuring an effective transition and ease the challenges associated with it.

A Percutaneous Endoscopic Colostomy Tube to the Rescue.

Percutaneous endoscopic colostomy (PEC) tube placement is a minimally invasive procedure used to treat recurrent colonic pseudo-obstruction, sigmoid volvulus, chronic intractable constipation, and neurogenic bowel. PEC is a viable treatment alternative for patients who have failed conservative therapies and are deemed high risk for surgical management. We present a case of acute colonic pseudo-obstruction after Clostridioides difficile infection that was unresponsive to medical treatment or endoscopic decompression. A PEC tube was placed into the transverse colon with successful resolution of the colonic distension.

Disseminated Histoplasmosis Presenting as Obstructive Jaundice.

Gastrointestinal manifestations in systemic fungal infection are not uncommon; however, obstructive jaundice due to lymphadenopathy is considered rare. We present a case of a 16-year-old male patient who presented with painless jaundice. Laboratory tests revealed direct hyperbilirubinemia with cholestatic liver injury. Chest and abdominal computed tomography showed mediastinal and porta hepatis lymphadenopathy, with severe biliary ductal dilatation proximal to an obstructing lymph node near the head of the pancreas. Endoscopic ultrasound showed a 22 × 35-mm lymph node with a mass effect on the common bile duct leading to obstructive jaundice. Infectious workup confirmed the diagnosis of disseminated histoplasmosis.

Autoimmune Hepatitis and Obstetrical Outcomes: A Nationwide Assessment.

INTRODUCTION: Previous research identified AIH as linked to unfavorable obstetrical outcomes in a US nationwide retrospective study from 2012-2016. Our aim is to update the literature and strengthen the AIH-pregnancy outcomes relationship. METHODS: Using the National Inpatient Sample database in the US, from 2016 to 2020, we compared pregnant females with a diagnosis of AIH to those with and without other chronic liver diseases (CLD), using ICD-10-CM codes. Baseline characteristics were analyzed using T-test and Chi-Square, and multivariate regression was used to estimate the differences in maternal outcomes adjusted for age, race, insurance status, geographical location, hospital characteristics, and comorbid conditions. RESULTS: Out of 19,392,328 hospitalizations for pregnant females ≥ 18 years old from 2016 to 2020, 1095 had AIH, 179,655 had CLD, and 19,206,696 had no CLD. No mortality was observed among individuals with AIH. When compared to individuals without CLD, AIH was associated with an 82% increase in the odds of preterm delivery (AIH: 8% vs. Without CLD: 5%, adjusted Odds Ratio = 1.82, 95% CI 1.06-3.14), with no significant differences in gestational diabetes mellitus, hypertensive complications, and postpartum hemorrhage, and a 0.6 day longer hospital stay. Furthermore, there were no significant differences in outcomes between AIH and CLD. CONCLUSIONS: Our study reinforces the association of AIH with adverse obstetrical outcomes (e.g., preterm delivery), however, we found that there is no difference in GDM and hypertensive complications, as suggested in prior studies. Therefore, further investigations are needed to clarify the association between AIH and these obstetrical complications.

Comparison of viscous budesonide and fluticasone in the treatment of patients with eosinophilic esophagitis: a systematic review and meta-analysis.

Background: Steroids are an important pharmacologic treatment in patients with eosinophilic esophagitis (EoE). Fluticasone and budesonide are the 2 main steroid medications used in EOE treatment, but current United States (US) guidelines do not recommend one agent over the other. In this study, we conducted a meta-analysis to compare important patient outcomes when both agents are used. Methods: A comprehensive search of MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus was performed from each database's inception to March 29th, 2023. Two independent reviewers systematically identified trials that compared the effect of budesonide vs. fluticasone in the management of EoE. A meta-analysis was performed using a fixed-effects model. The primary outcome was the histologic response (defined as an eosinophil count <15 per high-power field) which reflects the response to treatment. Results: Three studies met our inclusion criteria and were included in the analysis, with a total of 272 patients. All studies were carried out in the US and 1 was a randomized controlled trial. Our meta-analysis showed no statistically significant difference with the use of budesonide compared to fluticasone in achieving a histologic response (odds ratio 1.29, 95% confidence interval 0.77-2.14; P=0.34; I2=0%). Conclusion: Our systematic review and meta-analysis indicated no difference between budesonide and fluticasone in achieving a histologic response in patients with EoE.

Racial Disparities in Liver Transplantation for Hepatocellular Carcinoma in the United States: An Update.

BACKGROUND: Previous studies have demonstrated a disparity in liver transplantation (LT) for hepatocellular carcinoma (HCC) among races in the United States (U.S.). AIMS: We aimed to update the literature on the odds, trends, and complications of LT in the treatment of hepatocellular carcinoma (HCC), among individuals of different racial backgrounds. METHODS: This is a nationwide study of adult individuals admitted for LT with a primary diagnosis of HCC. Using weighted data from the National Inpatient Sample (NIS) database, we compared the odds of LT among different races from 2016 to 2020, using a multivariate regression analysis. We further assessed the trends and outcomes of LT among races. RESULTS: A total of 112,110 adult were hospitalized with a primary diagnosis of HCC. 3020 underwent LT. When compared to Whites, the likelihood of undergoing LT for HCC was significantly reduced in Blacks (OR = 0.60, 95% CI = 0.46-0.78). Further, Blacks had increased mortality rates (7% in Blacks vs. 1% in Whites, p < 0.001), sepsis (11% in Blacks vs. 3% in Whites, p = 0.015), and acute kidney injury (AKI) (54% in Blacks vs. 31% in Whites, p < 0.001) following LT. CONCLUSIONS: Individuals identifying as Blacks were less likely to undergo LT for HCC, and more likely to develop complications. Further initiatives are warranted to mitigate the existing disparities among racial groups.

Timely Endoscopic Recognition of Aortoesophageal Fistula With Successful Treatment.

Aortoesophageal fistula (AEF) is a devastating cause of upper gastrointestinal bleeding that occurs because of pathologic communication of the esophagus with the aorta. Bleeding AEF has high mortality even with appropriate interventions. In this study, we present a case of a 52-year-old man who presented with hematemesis, which was found to be due to an actively bleeding AEF. Prompt identification of the fistula led to multiple endoscopic interventions that stabilized the patient and allowed him to undergo emergent endovascular aortic stent placement with successful bleeding control.

Transjugular Intrahepatic Portosystemic Shunt With or Without Gastroesophageal Variceal Embolization for the Prevention of Variceal Rebleeding: A Systematic Review and Meta-Analysis.

Background: The role of variceal embolization (VE) during transjugular intrahepatic portosystemic shunt (TIPS) creation for preventing gastroesophageal variceal rebleeding remains controversial. Therefore, we performed a meta-analysis to compare the incidence of variceal rebleeding, shunt dysfunction, encephalopathy, and death between patients treated with TIPS alone and those treated with TIPS in combination with VE. Methods: We performed a literature search using PubMed, EMBASE, Scopus, and Cochrane databases for all studies comparing the incidence of complications between TIPS alone and TIPS with VE. The primary outcome was variceal rebleeding. Secondary outcomes include shunt dysfunction, encephalopathy, and death. Subgroup analysis was performed based on the type of stent (covered vs. bare metal). The random-effects model was used to calculate the relative risk (RR) with the corresponding 95% confidence intervals (CIs) of outcome. A P value < 0.05 was considered statistically significant. Results: Eleven studies with a total of 1,075 patients were included (597: TIPS alone and 478: TIPS plus VE). Compared to the TIPS alone, the TIPS with VE had a significantly lower incidence of variceal rebleeding (RR: 0.59, 95% CI: 0.43 - 0.81, P = 0.001). Subgroup analysis revealed similar results in covered stents (RR: 0.56, 95% CI: 0.36 - 0.86, P = 0.008) but there was no significant difference between the two groups in the subgroup analysis of bare stents and combined stents. There was no significant difference in the risk of encephalopathy (RR: 0.84, 95% CI: 0.66 - 1.06, P = 0.13), shunt dysfunction (RR: 0.88, 95% CI: 0.64 - 1.19, P = 0.40), and death (RR: 0.87, 95% CI: 0.65 - 1.17, P = 0.34). There were similarly no differences in these secondary outcomes between groups when stratified according to type of stent. Conclusions: Adding VE to TIPS reduced the incidence of variceal rebleeding in patients with cirrhosis. However, the benefit was observed with covered stents only. Further large-scale randomized controlled trials are warranted to validate our findings.

Prevalence of Colonic Polyps in Patients Undergoing Kidney Transplant Evaluation: A Meta-Analysis and Systematic Review.

OBJECTIVES: Colorectal canceris the third most common cancer worldwide, and kidney transplant patients have up to a 2.5-fold increased risk of colorectal cancer compared with the general population. Presently, colorectal cancer screening recommendations in kidney transplant candidates are the same as for the general population. We explored the literature on the prevalence of colonic polyps in patients with renal failure undergoing screening colonoscopy as part of kidney transplant evaluation. MATERIALS AND METHODS: We conducted a systematic review in PubMed, Embase, and Cochrane databases from inception through June 2023 to identify studies that explored the prevalence of colonic polyps in patients with chronic kidney disease undergoing a screening colonoscopy as part of their pretransplant evaluation. RESULTS: Of 937 patients, 371 had ≥1 polyp on their screening colonoscopy (39.6%; 95% CI, 29.3%-50.3%), 243 patients had ≥1 adenoma (25.9%; 95% CI, 14.3%- 39.6%), and 75 had ≥1 high-risk adenoma (8.7%; 95% CI, 6.9%-10.7%). Pooled analysis of the 2 studies comparing patients with end-stage renal disease versus matched control groups indicated higher pooled prevalence of adenomas in the end-stage renal disease group (33.4%) versus the control group (23.9%). CONCLUSIONS: Our results suggest an average or increased prevalence of polyps and adenomatous polyps in patients with chronic kidney disease undergoing colonoscopy during evaluation for kidney transplant. The pooled analysis of the studies comparing the end-stage renal disease population versus a matched control group indicates higher prevalence of adenomatous polyps in patients with end-stage renal disease. Multiple studies have shown that screening colonoscopy in this patient group is safe and does not delay kidney transplant evaluation or waitlistrates; hence, screening colonoscopy should be routinely considered.

Endoscopy for the diagnosis and treatment of gastrointestinal bleeding caused by malignancy.

BACKGROUND AND AIM: The diagnosis and treatment of gastrointestinal (GI) bleeding secondary to malignancy can be challenging. Endoscopy is the gold standard to diagnose and treat gastrointestinal bleeding but clinical characteristics and outcomes of patients with malignancy-related bleeding are not well understood. This study aims to look at clinical characteristics, endoscopic findings, safety and clinical outcomes of endoscopic interventions for GI malignancy-related bleeding. METHODS: We retrospectively reviewed outcomes of patients with confirmed GI malignancies who underwent endoscopy for GI bleeding at MD Anderson Cancer Center between 2010 and 2019. Cox hazard analysis was conducted to identify factors associated with survival. RESULTS: A total of 313 patients were included, with median age of 59 years; 74.8% were male. The stomach (30.0%) was the most common tumor location. Active bleeding was evident endoscopically in 47.3% of patients. Most patients (77.3%) did not receive endoscopic treatment. Of the patients who received endoscopic treatment, 57.7% had hemostasis. No endoscopy-related adverse events were recorded. Endoscopic treatment was associated with hemostasis (P < 0.001), but not decreased recurrent bleeding or mortality. Absence of active bleeding on endoscopy, stable hemodynamic status at presentation, lower cancer stage, and surgical intervention were associated with improved survival. CONCLUSIONS: This study indicates that endoscopy is a safe diagnostic tool in this patient population; while endoscopic treatments may help achieve hemostasis, it may not decrease the risk of recurrent bleeding or improve survival.

A Rare Case of Metastatic Merkel Cell Carcinoma to the Stomach and Pancreas Presenting With Upper Gastrointestinal Bleeding and Obstructive Jaundice.

Merkel cell carcinoma (MCC) is a rare and aggressive primary neuroendocrine tumor of the skin. Gastrointestinal (GI) metastasis in MCC is uncommon. We present a case of MCC with metastasis to the stomach, duodenum, and pancreas presenting with melena and obstructive jaundice. A large, bleeding metastatic mass was identified in the duodenum. Hemostasis was achieved with coil embolization. Endoscopic retrograde cholangiopancreatography with stenting of the common bile duct was performed to relieve the obstruction. Close surveillance with positron emission tomography/computed tomography scan and possible GI endoscopy should be performed in cases with distant metastasis to identify and treat early GI tract lesions.

Jejunal Submucosal Hemangioma as a Cause of Massive Gastrointestinal Bleeding: A Case Report.

Small intestinal hemangiomas are uncommon tumors that frequently present with gastrointestinal bleeding (GIB). Diagnosis, detection, and treatment can be challenging and may require surgical intervention. An 81-year-old female presented with melena. Video capsule endoscopy revealed active bleeding in the proximal jejunum and push enteroscopy identified a polypoid nodule with central umbilication. The patient underwent laparoscopic resection and jejunal submucosal hemangioma was detected. Submucosal hemangiomas are a rare cause of GIB. As the most common site of submucosal hemangiomas is the mid-jejunum, they are not easy to detect. Surgical intervention is usually required for a definitive diagnosis and definitive treatment.

Spontaneous Bacterial Peritonitis: We Are Still Behind.

Spontaneous bacterial peritonitis (SBP) is an infection in the ascitic fluid. Despite published guidelines, an inappropriate diagnosis of SBP is frequent. In this study, we aim to evaluate guideline adherence in diagnosing SBP. This is a retrospective study conducted between January 2015 and January 2018. Based on the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of Liver (EASL), two authors judged guideline adherence in SBP diagnosis and management. One hundred and six patients were included in the study, and 93% were hospitalized. The mean age was 56.9 years, and 62 patients were males. In addition, Caucasians were the most common ethnicity (86.8%). The authors judged that only 52.4% of patients were appropriately diagnosed, and only 67.3% were managed with proper treatment. Inpatient mortality was documented in five patients, and the readmission rate within 30-days after discharge was 29.3%. In conclusion, SBP is a common complication of cirrhosis, which can be managed with adherence to published guidelines. In our population, guidelines were not implemented in diagnosing nearly half the SBP patients, mostly due to misdiagnosis of SBP with secondary peritonitis or non-neutrocytic bacteriascites, starting antibiotics before performing the paracentesis, and even giving broad-coverage antibiotics when not indicated. Further efforts are needed to enhance adherence to guidelines in clinical practice.