Sedation reversal trends at outpatient ambulatory endoscopic center vs in-hospital ambulatory procedure center using a triage protocol.

BACKGROUND: Routine outpatient endoscopy is performed across a variety of outpatient settings. A known risk of performing endoscopy under moderate sedation is the potential for over-sedation, requiring the use of reversal agents. More needs to be reported on rates of reversal across different outpatient settings. Our academic tertiary care center utilizes a triage tool that directs higher-risk patients to the in-hospital ambulatory procedure center (APC) for their procedure. Here, we report data on outpatient sedation reversal rates for endoscopy performed at an in-hospital APC vs at a free-standing ambulatory endoscopy digestive health center (AEC-DHC) following risk stratification with a triage tool. AIM: To observe the effect of risk stratification using a triage tool on patient outcomes, primarily sedation reversal events. METHODS: We observed all outpatient endoscopy procedures performed at AEC-DHC and APC from April 2013 to September 2019. Procedures were stratified to their respective sites using a triage tool. We evaluated each procedure for which sedation reversal with flumazenil and naloxone was recorded. Demographics and characteristics recorded include patient age, gender, body mass index (BMI), American Society of Anesthesiologists (ASA) classification, procedure type, and reason for sedation reversal. RESULTS: There were 97366 endoscopic procedures performed at AEC-DHC and 22494 at the APC during the study period. Of these, 17 patients at AEC-DHC and 9 at the APC underwent sedation reversals (0.017% vs 0.04%; P = 0.06). Demographics recorded for those requiring reversal at AEC-DHC vs APC included mean age (53.5 ± 21 vs 60.4 ± 17.42 years; P = 0.23), ASA class (1.66 ± 0.48 vs 2.22 ± 0.83; P = 0.20), BMI (27.7 ± 6.7 kg/m2 vs 23.7 ± 4.03 kg/m2; P = 0.06), and female gender (64.7% vs 22%; P = 0.04). The mean doses of sedative agents and reversal drugs used at AEC-DHC vs APC were midazolam (5.9 ± 1.7 mg vs 8.9 ± 3.5 mg; P = 0.01), fentanyl (147.1 ± 49.9 µg vs 188.9 ± 74.1 µg; P = 0.10), flumazenil (0.3 ± 0.18 µg vs 0.17 ± 0.17 µg; P = 0.13) and naloxone (0.32 ± 0.10 mg vs 0.28 ± 0.12 mg; P = 0.35). Procedures at AEC-DHC requiring sedation reversal included colonoscopies (n = 6), esophagogastroduodenoscopy (EGD) (n = 9) and EGD/colonoscopies (n = 2), whereas APC procedures included EGDs (n = 2), EGD with gastrostomy tube placement (n = 1), endoscopic retrograde cholangiopancreatography (n = 2) and endoscopic ultrasound's (n = 4). The indications for sedation reversal at AEC-DHC included hypoxia (n = 13; 76%), excessive somnolence (n = 3; 18%), and hypotension (n = 1; 6%), whereas, at APC, these included hypoxia (n = 7; 78%) and hypotension (n = 2; 22%). No sedation-related deaths or long-term post-sedation reversal adverse outcomes occurred at either site. CONCLUSION: Our study highlights the effectiveness of a triage tool used at our tertiary care hospital for risk stratification in minimizing sedation reversal events during outpatient endoscopy procedures. Using a triage tool for risk stratification, low rates of sedation reversal can be achieved in the ambulatory settings for EGD and colonoscopy.

Outcomes of colon self-expandable metal stents for malignant vs benign indications at a tertiary care center and review of literature.

BACKGROUND: Endoscopic placement of a self-expandable metal stent (SEMS) is a minimally invasive treatment for use in malignant and benign colonic obstruction. However, their widespread use is still limited with a nationwide analysis showing only 5.4% of patients with colon obstruction undergoing stent placement. This underutilization could be due to perceived increase risk of complications with stent placement. AIM: To review long- and short-term clinical success of SEMS use for colonic obstruction at our center. METHODS: We retrospectively reviewed all the patients who underwent colonic SEMS placement over a eighteen year period (August 2004 through August 2022) at our academic center. Demographics including age, gender, indication (malignant and benign), technical success, clinical success, complications (perforation, stent migration), mortality, and outcomes were recorded. RESULTS: Sixty three patients underwent colon SEMS over an 18-year period. Fifty-five cases were for malignant indications, 8 were for benign conditions. The benign strictures included diverticular disease stricturing (n = 4), fistula closure (n = 2), extrinsic fibroid compression (n = 1), and ischemic stricture (n = 1). Forty-three of the malignant cases were due to intrinsic obstruction from primary or recurrent colon cancer; 12 were from extrinsic compression. Fifty-four strictures occurred on the left side, 3 occurred on the right and the rest in transverse colon. The total malignant case (n = 55) procedural success rate was 95% vs 100% for benign cases (P = 1.0, NS). Overall complication rate was significantly higher for benign group: Four complications were observed in the malignant group (stent migration, restenosis) vs 2 of 8 (25%) for benign obstruction (1-perforation, 1-stent migration) (P = 0.02). When stratifying complications of perforation and stent migration there was no significant difference between the two groups (P = 0.14, NS). CONCLUSION: Colon SEMS remains a worthwhile option for colonic obstruction related to malignancy and has a high procedural and clinical success rate. Benign indications for SEMS placement appear to have similar success to malignant. While there appears to be a higher overall complication rate in benign cases, our study is limited by sample size. When evaluating for perforation alone there does not appear to be any significant difference between the two groups. SEMS placement may be a practical option for indications other that malignant obstruction. Interventional endoscopists should be aware and discuss the risk for complications in setting of benign conditions. Indications in these cases should be discussed in a multi-disciplinary fashion with colorectal surgery.

A Combined DNA/RNA-based Next-Generation Sequencing Platform to Improve the Classification of Pancreatic Cysts and Early Detection of Pancreatic Cancer Arising From Pancreatic Cysts.

OBJECTIVE: We report the development and validation of a combined DNA/RNA next-generation sequencing (NGS) platform to improve the evaluation of pancreatic cysts. BACKGROUND AND AIMS: Despite a multidisciplinary approach, pancreatic cyst classification, such as a cystic precursor neoplasm, and the detection of high-grade dysplasia and early adenocarcinoma (advanced neoplasia) can be challenging. NGS of preoperative pancreatic cyst fluid improves the clinical evaluation of pancreatic cysts, but the recent identification of novel genomic alterations necessitates the creation of a comprehensive panel and the development of a genomic classifier to integrate the complex molecular results. METHODS: An updated and unique 74-gene DNA/RNA-targeted NGS panel (PancreaSeq Genomic Classifier) was created to evaluate 5 classes of genomic alterations to include gene mutations (e.g., KRAS, GNAS, etc.), gene fusions and gene expression. Further, CEA mRNA ( CEACAM5 ) was integrated into the assay using RT-qPCR. Separate multi-institutional cohorts for training (n=108) and validation (n=77) were tested, and diagnostic performance was compared to clinical, imaging, cytopathologic, and guideline data. RESULTS: Upon creation of a genomic classifier system, PancreaSeq GC yielded a 95% sensitivity and 100% specificity for a cystic precursor neoplasm, and the sensitivity and specificity for advanced neoplasia were 82% and 100%, respectively. Associated symptoms, cyst size, duct dilatation, a mural nodule, increasing cyst size, and malignant cytopathology had lower sensitivities (41-59%) and lower specificities (56-96%) for advanced neoplasia. This test also increased the sensitivity of current pancreatic cyst guidelines (IAP/Fukuoka and AGA) by >10% and maintained their inherent specificity. CONCLUSIONS: PancreaSeq GC was not only accurate in predicting pancreatic cyst type and advanced neoplasia but also improved the sensitivity of current pancreatic cyst guidelines.

Design and off-target prediction for antisense oligomers targeting bacterial mRNAs with the MASON web server.

Antisense oligomers (ASOs), such as peptide nucleic acids (PNAs), designed to inhibit the translation of essential bacterial genes, have emerged as attractive sequence- and species-specific programmable RNA antibiotics. Yet, potential drawbacks include unwanted side effects caused by their binding to transcripts other than the intended target. To facilitate the design of PNAs with minimal off-target effects, we developed MASON (make antisense oligomers now), a web server for the design of PNAs that target bacterial mRNAs. MASON generates PNA sequences complementary to the translational start site of a bacterial gene of interest and reports critical sequence attributes and potential off-target sites. We based MASON's off-target predictions on experiments in which we treated Salmonella enterica serovar Typhimurium with a series of 10-mer PNAs derived from a PNA targeting the essential gene acpP but carrying two serial mismatches. Growth inhibition and RNA-sequencing (RNA-seq) data revealed that PNAs with terminal mismatches are still able to target acpP, suggesting wider off-target effects than anticipated. Comparison of these results to an RNA-seq data set from uropathogenic Escherichia coli (UPEC) treated with eleven different PNAs confirmed that our findings are not unique to Salmonella We believe that MASON's off-target assessment will improve the design of specific PNAs and other ASOs.

Electronic Health Record Work Demands for Gastroenterology and Hepatology Providers: A Prospective Use Analysis and Survey Study.

BACKGROUND AND AIMS: There is a paucity of research on the use of the electronic health record (EHR) by gastroenterology and hepatology providers and its effect on work-life balance. Our aim was to study the after-hour EHR work completed among providers within a multispecialty academic practice. METHODS: Time spent completing EHR tasks during evening hours (7p-7a) and days off was prospectively recorded for 35 providers over six consecutive months at a single center. Type and time of EHR tasks completed were compared based on subspecialty, academic degree, academic track category, identified gender, and number of weekly assigned clinical days worked. Prior to the data collection, providers filled out a survey regarding EHR use, work hours, and work-life balance. RESULTS: All providers used EHR during evening hours and during days off. The total mean after-hours time spent completing EHR tasks was 18.4 m (± 13.0) per day and 45.0 m (± 25.8) during days off. There was significant variation in the daily mean after-hours time spent completing EHR tasks among subspecialties, range 45.3 m (± 27.1) (advanced endoscopy)-28.7 m (± 22.7) (hepatology), and among providers who work clinically > 7.5 days per week versus those who do not, 42.1 m (± 25.7) vs 30.0 m (± 14.0). The most common after-hours EHR task was note completion. 83% providers reported being unable to complete EHR tasks during allotted workday time and 87% report that EHR tasks interfered with family life; 74% with social life. CONCLUSION: Gastroenterology and hepatology providers spend a significant amount of after-hour time completing EHR tasks which is perceived to interfere with family/social life.

Colorectal Cancer Screening After Changes in US Preventive Services Task Force Guidelines With Increased Screening Options.

INTRODUCTION: In 2016, the US Preventive Services Task Force (USPSTF) added multitarget stool DNA and computed tomography colonography (CTC) as accepted colorectal cancer screening modalities to the already recommended tests: fecal immunochemical test (FIT), sigmoidoscopy, and colonoscopy. The aim of our study was to determine trends in screening after the USPSTF update, with the effect of additional tests on the use of existing colorectal cancer screening modalities and overall screening rates. METHODS: We prospectively compared monthly colorectal cancer overall screening rates and the mean total numbers of patients screened by multitarget stool DNA, colonoscopy, sigmoidoscopy, CTC, and FIT 6 months prior to the new USPSTF guidelines until 30 months after. RESULTS: At completion of the study, 72,202 patients were eligible for screening. The overall rate of eligible patients screened for colorectal cancer did not change (80.9% vs 81.3%; P = 0.287). There was a significant increase in the percent of patients screened with multitarget stool DNA (1.6% to 15.6%; P = .001) and a significant decrease in the percent of patients screened using CTC (3.8 % to 1.5%; P = .004), FIT (9.3% to 4.9%; P = .003), and sigmoidoscopy (2.4% to 1.5%, P = .024). There was a nonsignificant decrease in the percent use of screening colonoscopy, from 82.9 % to 76.5% (P = .313). CONCLUSION: While the overall colorectal cancer screening rate did not increase after the USPSTF update with additional recommended screening tests, practice patterns did change with a shift in the type of screening test used.

Prospective Comparison of Moderate Conscious Sedation and Anesthesia Assistance for the Performance of Endoscopic Retrograde Cholangiopancreatography (ERCP).

Objectives: Recent trends have favored the use of anesthesia personnel more frequently for advanced endoscopic procedures. We hypothesize a selective sedation approach based on patient and procedural factors using either moderate conscious sedation (MCS) or general anesthesia (GA) will result in similar outcomes and safety with significant cost savings. Methods: A 12-month prospective study of all adult endoscopic retrograde cholangiopancreatography (ERCPs) performed at a tertiary medical center was enrolled. Technical success, cannulation rates, procedural related complications, procedure time, and cost were compared between MCS and GA. Results: A total of 876 ERCPs were included in the study with 74% performed with MCS versus 26% with GA. The intended intervention was completed successfully in 95% of cases with MCS versus 96% cases with GA (p = 0.59). Cannulation success rates with MCS were 97.5 versus 97.8% with GA (p = 0.81). Overall, adverse event rates were similar in both groups (MCS: 6.6% vs. GA: 9.2%, p = 0.21). Mean procedure time was less for MCS versus GA, 18.3 and 26 minutes, respectively (p < 0.0001). Selective use of MCS vs. universal sedation with GA resulted in estimated savings of $8,190 per case and $4,735,202 per annum. Conclusions: Preselection of ERCP sedation of moderate conscious sedation versus general anesthesia based upon patient risk factors and planned therapeutic intervention allows for the majority of ERCPs to be completed with MCS with similar rates of technical success and improvement in resource utilization and cost savings compared to performing ERCPs universally with anesthesia assistance.

Hemosuccus Pancreaticus Following Acute Pancreatitis in a 12-years-old Boy Secondary to Pancreatic Pseudoaneurysm Treated With Endovascular Coil Embolization.

Hemosuccus pancreaticus is a very rare cause of upper gastrointestinal bleeding in children. It is defined as bleeding from the pancreatic or peripancreatic vessels into the main pancreatic duct and may be life-threatening. We present the case of a 12-year-old boy with hematemesis and severe anemia that developed following an episode of acute pancreatitis. Upper endoscopy did not reveal a bleeding source. An endoscopic retrograde cholangiopancreatography performed for the evaluation of common bile duct obstruction identified bleeding from the pancreatic duct. Subsequently, the bleeding source, a pseudoaneurysm of the splenic artery, was identified by conventional angiography and occluded with coil embolization. The diagnosis of hemosuccus pancreaticus may be difficult in children due to rare occurrence and the unusual anatomical site; hence, a high index of suspicion is needed in a patient with a history of pancreatitis who presents with intermittent upper gastrointestinal bleeding and normal upper endoscopy.

Safety and Efficacy of Moderate Sedation in Super Obese Patients Undergoing Lower and Upper GI Endoscopy: a Case-Control Study.

PURPOSE: Obesity is a disease of increasing prevalence. There is minimal research on the safety of sedation for general endoscopic procedures among super obese patients (BMI ≥ 50). The aim of our study was to evaluate the safety of moderate sedation and endoscopic procedural outcomes for super obese patients in a case-control study. MATERIALS AND METHODS: We completed an age and sex-matched case-control study comparing 132 super obese patients with 132 non-obese controls. We assessed intra-procedure adverse events, delayed adverse events, doses of sedation medication used, and procedure duration at a tertiary care setting. RESULTS: The mean BMI for the obese cohort was 55.6 compared with 22.5 for the controls (P < 0.001). The mean intra-procedure fentanyl and midazolam dose was higher for the obese patients compared with the controls, fentanyl 180 mcg, midazolam 7.7 mg vs fentanyl 148 mcg, midazolam 6.4 mg, respectively (P < 0.001). There was a significantly higher percentage of brief intra-procedure hypoxia (oxygen blood saturation < 90%) for the obese patients compared with the controls, 5% vs 0% (P = 0.02). There was no difference in delayed adverse events with 2% of the cases and 2% of the controls having delayed adverse events (P = 1.0). Procedure completion rates were 100% for both cases and controls. CONCLUSION: General endoscopic procedures can be safely and effectively performed in super obese patients with moderate sedation. Brief intra-procedure hypoxia more commonly occurs in super obese patients, and higher medication doses are required.

A Prospective, Randomized Comparison of Duodenoscope Reprocessing Surveillance Methods.

Duodenoscope use in healthcare facilities has been associated with transmission of multidrug resistant pathogens between patients. To assist healthcare facilities in monitoring the quality of their duodenoscope reprocessing procedures and limit patient risk of infection, the Centers for Disease Control and Prevention (CDC) deployed voluntary interim duodenoscope sampling and culturing surveillance protocols in 2015. Though the interim methods were widely adopted, alternative surveillance protocols were developed and implemented at individual institutions. Here, we compared two sampling methods-the 2015 CDC interim protocol and an alternative protocol developed by the University of Wisconsin Hospitals and Clinics (UWHC). We hypothesized that the UWHC protocol would detect a higher incidence of bacterial contamination from reprocessed duodenoscopes. A total of 248 sampling events were performed at UWHC. The CDC protocol (n = 129 sampling events) required culturing samples collected from each duodenoscope after brushing its terminal end and flushing its lumen with sterile water. The UWHC protocol (n = 119 sampling events) required culturing samples collected from each duodenoscope after swabbing its elevator, immersing its terminal end into broth and flushing its lumen with saline. With the CDC method, 8.53% (n = 11) of the duodenoscopes sampled were positive for bacterial growth with 15 isolates recovered. Using the UWHC method, 15.13% (n = 18) of cultures were positive for bacterial growth with 20 isolates recovered. The relative risk of identifying a contaminated duodenoscope using the CDC interim method, however, was not different than when using the UWHC protocol. Mean processing time (27.35 and 5.11 minutes, p < 0.001) and total cost per sample event ($17.87 and $15.04) were lower using the UWHC method. As the UWHC protocol provides similar detection rates as the CDC protocol, the UWHC method is useful, provided the shorter processing time and lower cost to perform.

Cytology with rapid on-site examination (ROSE) does not improve diagnostic yield of EUS-FNA of pancreatic cystic lesions.

BACKGROUND: Cytology with rapid on-site evaluation (ROSE) has been shown to increase the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for solid pancreatic lesions. No data exists on the need for rapid onsite cytology in the evaluation of pancreatic cystic lesions (PCLs). The purpose of this study is to determine whether onsite cytology impacts the diagnostic yield of EUS-FNA of PCLs. METHODS: We prospectively examined all patients with PCLs who underwent EUS-FNA without onsite cytology over a 6-month period and compared this to a historical cohort of patients with PCLs who underwent EUS-FNA with ROSE in the previous 6 months. Comparison was made between the two groups based upon patient demographics, EUS cyst characteristics, and FNA fluid & cytopathology results. RESULTS: A total of 100 EUS-FNA exams for PCLs were identified: 46 with ROSE and 54 without onsite cytology. The majority of cytology findings were negative or nondiagnostic, 87.0% in the ROSE group, 77.8% in the group without onsite cytology. There was no difference using EUS-FNA without onsite cytology compared to ROSE when measuring total diagnostic yield (22.2% vs 13.0%, P = .30), number of nondiagnostic specimens (50% vs 54%, P = .69), and number of needle passes (1.51 vs 1.57, P = .68). CONCLUSIONS: (a) The majority of cytology results from EUS-FNA of cystic lesions are negative or nondiagnostic. (b) Having rapid onsite cytology evaluation of cystic lesions does not affect the number of needle passes nor diagnostic yield and is thus not recommended.