Incidence, Predictors, and Outcomes of Clinically Significant Post-ERCP Bleeding: a Contemporary Multi-center Study.

BACKGROUND AIMS: Clinically significant post-endoscopic retrograde cholangiopancreatography (ERCP) bleeding (CSPEB) is common. Contemporary estimates of risk are lacking. We aimed to identify risk factors for and outcomes following CSPEB. METHODS: We analyzed multi-center prospective ERCP data between 2018-2023 with 30-day follow-up. The primary outcome was CSPEB, defined as hematemesis, melena, or hematochezia resulting in: hemoglobin drop ≥20 g/L or transfusion and/or endoscopy to evaluate suspected bleeding, and/or unplanned healthcare visitation and/or prolongation of existing admission. Firth logistic regression was employed. P-values <0.05 were significant, with odds ratios (ORs) and 95% confidence intervals reported. RESULTS: CSPEB occurred following 129 (1.5%) of 8,517 ERCPs (mean onset 3.2 days), with 110 of 4,849 events (2.3%) occurring following higher-risk interventions (sphincterotomy, sphincteroplasty, pre-cut sphincterotomy, and/or needle-knife access). CSPEB patients required endoscopy and transfusion in 86.0% and 53.5% of cases, respectively, with three cases (2.3%) being fatal. P2Y12 inhibitors were held for a median of 4 days (IQR 4) prior to higher-risk ERCP. Following higher-risk interventions, P2Y12 inhibitors (OR 3.33, 1.26-7.74), warfarin (OR 8.54, 3.32-19.81), dabigatran (OR 13.40, 2.06-59.96), rivaroxaban (OR 7.42, 3.43-15.24) and apixaban (OR 4.16, 1.99-8.20) were associated with CSPEB. Significant intraprocedural bleeding post sphincterotomy (OR 2.32, 1.06-4.60), but not post sphincteroplasty, was also associated. Concomitant cardiorespiratory events occurred more frequently within 30 days following CSPEB (OR 12.71, 4.75-32.54). CONCLUSIONS: Risks of antiplatelet-related CSPEB may be underestimated by endoscopists based on observations of suboptimal holding before higher-risk ERCP. Appropriate periprocedural antithrombotic management is essential and could represent novel quality initiative targets.

Comparative effectiveness of an individualized model of hemodialysis vs conventional hemodialysis: a study protocol for a multicenter randomized controlled trial (the TwoPlus trial).

BACKGROUND: Most patients starting chronic in-center hemodialysis (HD) receive conventional hemodialysis (CHD) with three sessions per week targeting specific biochemical clearance. Observational studies suggest that patients with residual kidney function can safely be treated with incremental prescriptions of HD, starting with less frequent sessions and later adjusting to thrice-weekly HD. This trial aims to show objectively that clinically matched incremental HD (CMIHD) is non-inferior to CHD in eligible patients. METHODS: An unblinded, parallel-group, randomized controlled trial will be conducted across diverse healthcare systems and dialysis organizations in the USA. Adult patients initiating chronic hemodialysis (HD) at participating centers will be screened. Eligibility criteria include receipt of fewer than 18 treatments of HD and residual kidney function defined as kidney urea clearance ≥3.5 mL/min/1.73 m2 and urine output ≥500 mL/24 h. The 1:1 randomization, stratified by site and dialysis vascular access type, assigns patients to either CMIHD (intervention group) or CHD (control group). The CMIHD group will be treated with twice-weekly HD and adjuvant pharmacologic therapy (i.e., oral loop diuretics, sodium bicarbonate, and potassium binders). The CHD group will receive thrice-weekly HD according to usual care. Throughout the study, patients undergo timed urine collection and fill out questionnaires. CMIHD will progress to thrice-weekly HD based on clinical manifestations or changes in residual kidney function. Caregivers of enrolled patients are invited to complete semi-annual questionnaires. The primary outcome is a composite of patients' all-cause death, hospitalizations, or emergency department visits at 2 years. Secondary outcomes include patient- and caregiver-reported outcomes. We aim to enroll 350 patients, which provides ≥85% power to detect an incidence rate ratio (IRR) of 0.9 between CMIHD and CHD with an IRR non-inferiority of 1.20 (α = 0.025, one-tailed test, 20% dropout rate, average of 2.06 years of HD per patient participant), and 150 caregiver participants (of enrolled patients). DISCUSSION: Our proposal challenges the status quo of HD care delivery. Our overarching hypothesis posits that CMIHD is non-inferior to CHD. If successful, the results will positively impact one of the highest-burdened patient populations and their caregivers. TRIAL REGISTRATION: Clinicaltrials.gov NCT05828823. Registered on 25 April 2023.

Unified Magnifying Endoscopic Classification (UMEC) of Gastrointestinal Lesions: A North American Validation Study.

Background and study aim: Magnifying endoscopy enables the diagnosis of advanced neoplasia throughout the gastrointestinal tract. The unified magnifying endoscopic classification (UMEC) framework unifies optical diagnosis criteria in the esophagus, stomach, and colon, dividing lesions into three categories: non-neoplastic, intramucosal neoplasia, and deep submucosal invasive cancer. This study aims to ascertain the performance of North American endoscopists when using the UMEC. Methods: In this retrospective cohort study, five North American endoscopists without prior training in magnifying endoscopy independently diagnosed images of gastrointestinal tract lesions using UMEC. All endoscopists were blinded to endoscopic findings and histopathological diagnosis. Using histopathology as the gold standard, the endoscopists' diagnostic performances using UMEC were evaluated. Results: A total of 299 lesions (77 esophagus, 92 stomach, and 130 colon) were assessed. For esophageal squamous cell carcinoma, the sensitivity, specificity, and accuracy ranged from 65.2% (95%CI: 50.9-77.9) to 87.0% (95%CI: 75.3-94.6), 77.4% (95%CI: 60.9-89.6) to 96.8% (95%CI: 86.8-99.8), and 75.3% to 87.0%, respectively. For gastric adenocarcinoma, the sensitivity, specificity, and accuracy ranged from 94.9% (95%CI: 85.0-99.1) to 100%, 52.9% (95%CI: 39.4-66.2) to 92.2% (95%CI: 82.7-97.5), and 73.3% to 93.3%. For colorectal adenocarcinoma, the sensitivity, specificity, and accuracy ranged from 76.2% (95%CI: 62.0-87.3) to 83.3% (95%CI: 70.3-92.5), 89.7% (95%CI: 82.1-94.9) to 97.7% (95%CI: 93.1-99.6), and 86.8% to 90.7%. Intraclass correlation coefficients indicated good to excellent reliability. Conclusion: UMEC is a simple classification that may be used to introduce endoscopists to magnifying narrow-band imaging and optical diagnosis, yielding satisfactory diagnostic accuracy.

Comparison of Endoscopic Mucosal Resection versus Endoscopic Submucosal Dissection for Barrett's Neoplasia and Esophageal Adenocarcinoma: A Systematic Review and Meta-Analysis.

BACKGROUND AND AIMS: Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are both accepted resection strategies for Barrett's esophagus-related neoplasia and esophageal adenocarcinoma (EAC). However, a lack of consensus exists regarding which technique offers superior outcomes. This study aims to systematically review the evidence comparing EMR versus ESD in treating Barrett's neoplasia and EAC. METHODS: We searched three databases (Embase, MEDLINE, Cochrane Central) until October 2023. We included studies comparing the efficacy of EMR and ESD for Barrett's neoplasia and EAC. Primary outcomes include en bloc, R0, and curative resection, complete remission of dysplasia (CRD), and local recurrence. Secondary outcomes encompass adverse events. RESULTS: Our search identified 905 records. Eleven studies were included in the final analyses. Data showed significantly higher en bloc resection rates with ESD [odds ratio(OR)=27.36 (95% confidence intervals(CI):7.12-105.21), p<0.01, 6 studies]. R0 resection rates were significantly higher with ESD [OR=5.73 (95%CI:2.32-14.16), p<0.01, 7 studies]. Curative resection rates tended to be higher with ESD [OR=3.49 (95%CI:0.86-14.14), p=0.080, 4 studies]. There was no significant difference in CRD rates [OR=0.92 (95%CI:0.37-2.26),p=0.86, 3 studies]. Local recurrence rates tended to be lower with ESD [OR=0.35 (95%CI: 0.11-1.04), p=0.058, 10 studies]. As for adverse events, there was no significant difference in bleeding, perforation, and postoperative stricture rates. CONCLUSIONS: This systematic review and meta-analysis demonstrates that ESD achieves higher en bloc, R0 and curative resection rates, with a tendency toward lower recurrence rates. These results suggest that ESD may be a more effective option for managing Barrett's neoplasia and EAC.

Kidney Care in Times of Crises: A Review.

The global burden of kidney disease is increasing, paralleled by a rising number of natural and man-made crises. During these tumultuous times, accessing vital healthcare resources becomes challenging, posing significant risks to individuals, particularly those with kidney disease. This review delves into the impact of crises on kidney disease, with a particular focus on acute kidney injury (AKI), kidney failure (KF), and kidney transplant (KT). Patients experiencing crush injuries leading to AKI may encounter delayed diagnosis due to the chaotic nature of disasters and limited availability of resources. In chronic crises, such as conflicts, patients with KF are particularly affected, and deviations from dialysis standards are unfortunately common, impacting morbidity and mortality rates. Additionally, crises also disrupt access to kidney transplants, potentially compromising transplant outcomes. This review underscores the critical importance of preparedness measures and proactive management for kidney disease in crisis settings. Collaborative efforts among government bodies, rescue teams, healthcare providers, humanitarian agencies, and nongovernmental organizations are imperative to ensure equitable and reasonable care for kidney disease patients during times of crises, with the aim of saving lives and improving outcomes.

Patient and Public Involvement in Inflammatory Bowel Disease Research-A Scoping Review.

Background: Interest in patient and public involvement in research has grown. Medical, health, and social care research has demonstrated several benefits of patient and public engagement, such as empowering user input and reducing attrition rates in clinical trials. To date, no study has reviewed patient engagement in inflammatory bowel disease (IBD). We aimed to describe the benefits, challenges, and best practices of patient engagement in IBD research. Methods: We performed a systematic search on MEDLINE, EMBASE, and Cochrane for all clinical IBD research studies in which patients were involved in the research process (1946- 2023). Patient input was considered in: (1) study design, (2) study execution, (3) research dissemination, and/or (4) other domains not specified here. Two authors independently screened and extracted data on type of engaged person(s), format of engagement, author-reported benefits, recommendations, and challenges. For each study, we reported the level of patient engagement and study adherence to standardized reporting guidelines. Results: After screening 9,355 articles, we included 51 for final analysis. IBD patients were most frequently engaged in study design. Patient engagement in IBD research improved recruitment rates and promoted the creation of user-friendly quality-of-life tools. Selection bias and recruitment difficulties were common challenges in the application of patient engagement. Authors recommended continuous patient involvement to address emerging priorities and cognitive interviewing to improve questionnaire clarity. Conclusions: Patient engagement represents an important step in promoting patient-centred care. According to study authors, implementing cognitive interviewing techniques, continuous patient involvement, and standardized reporting guidelines may improve future iterations of engagement in IBD.

Ergonomic wellness for the trainee in gastrointestinal endoscopy.

PURPOSE OF REVIEW: Endoscopy-related injuries (ERIs) are prevalent in gastrointestinal endoscopy. The aim of this review is to address the growing concern of ERIs by evaluating the ergonomic risk factors and the efficacy of interventions and educational strategies aimed at mitigating these risks, including novel approaches. RECENT FINDINGS: ERIs are highly prevalent, exacerbated by factors such as repetitive strain, nonneutral postures, suboptimal equipment design, and the procedural learning curve. Female sex and smaller hand sizes have been identified as specific risk factors. Recent guidelines underscore the importance of ergonomic education and the integration of ergonomic principles into the foundational training of gastroenterology fellows. Advances in equipment design focus on adaptability to different hand sizes and ergonomic positions. Furthermore, the incorporation of microbreaks and macrobreaks, along with neutral monitor and bed positioning, has shown promise in reducing the incidence of ERIs. Wearable sensors may be helpful in monitoring and promoting ergonomic practices among trainees. SUMMARY: Ergonomic wellness is paramount for gastroenterology trainees to prevent ERIs and ensure a sustainable career. Effective strategies include ergonomic education integrated into curricula, equipment design improvements, and procedural adaptations such as scheduled breaks and optimal positioning. Sensor-based and camera-based systems may allow for education and feedback to be provided regarding ergonomics to trainees in the future.

Relative Efficacies of Interventions to Improve the Quality of Screening-Related Colonoscopy: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.

BACKGROUND & AIMS: Significant variability exists in colonoscopy quality indicators, including adenoma detection rate (ADR). We synthesized evidence from randomized trials in a network meta-analysis on interventions to improve colonoscopy quality. METHODS: We included trials from database inceptions to September 25, 2023, of patients undergoing screening-related colonoscopy and presented efficacies of interventions within domains (periprocedural parameters, endoscopist-directed interventions, intraprocedural techniques, endoscopic technologies, distal attachment devices, and additive substances) compared to standard colonoscopy. The primary outcome was ADR. We used a Bayesian random-effects model using Markov-chain Monte Carlo simulation, with 10,000 burn-ins and 100,000 iterations. We calculated odds ratios with 95% credible intervals and present surface under the cumulative ranking (SUCRA) curves. RESULTS: We included 124 trials evaluating 37 interventions for the primary outcome. Nine interventions resulted in statistically significant improvements in ADR compared to standard colonoscopy (9-minute withdrawal time, dual observation, water exchange, i-SCAN [Pentax Ltd], linked color imaging, computer-aided detection, Endocuff [Olympus Corp], Endocuff Vision [Olympus Corp], and oral methylene blue). Dual observation (SUCRA, 0.84) and water exchange (SUCRA, 0.78) ranked highest among intraprocedural techniques; i-SCAN (SUCRA, 0.95), linked color imaging (SUCRA, 0.85), and computer-aided detection (SUCRA, 0.78) among endoscopic technologies; WingCap (A&A Medical Supply LLC) (SUCRA, 0.87) and Endocuff (SUCRA, 0.85) among distal attachment devices and oral methylene blue (SUCRA, 0.94) among additive substances. No interventions improved detection of advanced adenomas, and only narrow-band imaging improved detection of serrated lesions (odds ratio, 2.94; 95% credible interval, 1.46-6.25). CONCLUSIONS: Several interventions are effective in improving adenoma detection and overall colonoscopy quality, many of which are cost-free. These results can inform endoscopists, unit managers, and endoscopy societies on relative efficacies.

Establishment of standards for the referral of large nonpedunculated colorectal polyps: an international expert consensus using a modified Delphi process.

BACKGROUND AND AIMS: Resection of colorectal polyps has been shown to decrease the incidence and mortality of colorectal cancer. Large nonpedunculated colorectal polyps are often referred to expert centers for endoscopic resection, which requires relevant information to be conveyed to the therapeutic endoscopist to allow for triage and planning of resection technique. The primary objective of this study was to establish minimum expected standards for the referral of large non-pedunculated colonic polyps for potential endoscopic resection. METHODS: A Delphi method was used to establish consensus on minimum expected standards for the referral of large colorectal polyps among a panel of international endoscopy experts. The expert panel was recruited through purposive sampling, and 3 rounds of surveys were conducted to achieve consensus. Quantitative and qualitative data were analyzed for each round. RESULTS: A total of 24 international experts from diverse continents participated in the Delphi study, resulting in consensus on 19 statements related to the referral of large colorectal polyps. The identified factors, including patient demographic characteristics, relevant medications, lesion factors, photodocumentation, and the presence of a tattoo, were deemed important for conveying the necessary information to therapeutic endoscopists. The mean scores for the statements, which were scored on a scale of 1 to 10, ranged from 7.04 to 9.29, with high percentages of experts considering most statements as a very high priority. Subgroup analysis according to continent revealed some variations in consensus rates among experts from different regions. CONCLUSIONS: The identified consensus statements can aid in improving the triage and planning of resection techniques for large colorectal polyps, ultimately contributing to the reduction of colorectal cancer incidence and mortality.

Effectiveness and safety of thin vs. thick cold snare polypectomy of small colorectal polyps: Systematic review and meta-analysis.

Background and study aims Cold-snare polypectomy (CSP) is considered the standard of care for resection of colorectal polyps ≤10 mm. Data on the efficacy of CSP performed with thin-wire snares compared0 with thick-wire snares are conflicting. We performed a meta-analysis comparing complete resection (CR) and adverse event rates of CSP using thin-wire and thick-wire snares. Patients and methods Comparative studies of adult patients with ≧1 colorectal polyp(s) ≦10 mm who underwent CSP with thin-wire or thick-wire snares were included. We collected data on study, patient, polyp, and snare characteristics. The primary outcome was CR rate. Secondary outcomes were polyp retrieval rate, intraprocedural bleeding, delayed post-polypectomy bleeding, deep mural injury or perforation, patient discomfort, total sedation, and procedure time. We used random-effects models to calculate risk ratios for outcomes. We performed risk of bias assessments, rated the certainty of evidence, and assessed publication bias for all studies. Results We included four randomized controlled trials (RCTs) and two observational studies including 1316 patients with 1679 polyps (826 thin-wire CSPs and 853 thick-wire CSPs). There was no significant difference between thin-wire CSP (92.1%) and thick-wire CSP (87.7%) for RCTs (risk ratio [RR] 1.05, 95% confidence interval [CI] 0.94-1.16) or observational studies (78.1% versus 79.6%, RR 1.03, 95% CI 0.99-1.08). There were no significant differences in polyp retrieval rate or intraprocedural bleeding. There were no cases of delayed bleeding or perforation. Conclusions We found no differences in CR rates for CSP between thin-wire and thick-wire snares. CSP, regardless of snare type, is safe and effective for resection of small colorectal polyps.

Post-ERCP cholecystitis: Incidence, characteristics, and outcomes from a prospective multicenter biliary endoscopy registry.

BACKGROUND AND AIMS: The incidence, risk factors, and outcomes of post-ERCP cholecystitis are poorly described. We aimed to describe cases of post-ERCP cholecystitis from a prospective multicenter registry with protocolized 30-day follow-up. METHODS: Patient- and procedure-related data from 7 centers were obtained. The primary outcome was post-ERCP cholecystitis, defined according to a Delphi-based criteria and causal attribution system. Risk factors and outcomes were described for all cases. RESULTS: Seventeen cases of post-ERCP cholecystitis were identified among 4428 patients with gallbladders undergoing ERCP between 2018 and 2023 (incidence, 0.38%; 95% confidence interval, 0.20-0.57). In ERCPs with covered metal stenting, 7 of 467 resulted in cholecystitis (incidence, 1.50%; 95% confidence interval, 0.40-2.60). Patients had symptoms at a median of 5 days (interquartile range, 5) after ERCP. Management strategies included cholecystectomy, percutaneous cholecystostomy, and endoscopic stent removal/exchange. CONCLUSIONS: Estimates of post-ERCP cholecystitis incidence can inform discussions around procedural risk.

Unveiling the evolutionary history of lingonberry (Vaccinium vitis-idaea L.) through genome sequencing and assembly of European and North American subspecies.

Lingonberry (Vaccinium vitis-idaea L.) produces tiny red berries that are tart and nutty in flavor. It grows widely in the circumpolar region, including Scandinavia, northern parts of Eurasia, Alaska, and Canada. Although cultivation is currently limited, the plant has a long history of cultural use among indigenous communities. Given its potential as a food source, genomic resources for lingonberry are significantly lacking. To advance genomic knowledge, the genomes for 2 subspecies of lingonberry (V. vitis-idaea ssp. minus and ssp. vitis-idaea var. 'Red Candy') were sequenced and de novo assembled into contig-level assemblies. The assemblies were scaffolded using the bilberry genome (Vaccinium myrtillus) to generate a chromosome-anchored reference genome consisting of 12 chromosomes each with a total length of 548.07 Mb [contig N50 = 1.17 Mb, BUSCO (C%) = 96.5%] for ssp. vitis-idaea and 518.70 Mb [contig N50 = 1.40 Mb, BUSCO (C%) = 96.9%] for ssp. minus. RNA-seq-based gene annotation identified 27,243 and 25,718 genes on the respective assembly, and transposable element detection methods found that 45.82 and 44.58% of the genome were repeats. Phylogenetic analysis confirmed that lingonberry was most closely related to bilberry and was more closely related to blueberries than cranberries. Estimates of past effective population size suggested a continuous decline over the past 1-3 MYA, possibly due to the impacts of repeated glacial cycles during the Pleistocene leading to frequent population fragmentation. The genomic resource created in this study can be used to identify industry-relevant genes (e.g. anthocyanin production), infer phylogeny, and call sequence-level variants (e.g. SNPs) in future research.

Interobserver Reliability of the Paris Classification for Superficial Gastrointestinal Tract Neoplasms: A Systematic Review.

Background and study aims: The Paris classification characterizes the morphology of superficial gastrointestinal tract neoplasms. This system has been shown to predict the risk of submucosal invasion in certain subtypes of lesions. There is limited data that assesses its agreement amongst endoscopists. We performed a systematic review to summarize the available literature on the interobserver reliability (IOR) of the Paris classification. Methods: We conducted a search through December 2020 for studies reporting IOR of the Paris classification. Studies were included if they quantitatively evaluated the IOR of the Paris classification with at least five participating endoscopists. Two authors independently screened studies and abstracted data using an a priori-designed data collection form. Evaluation of study quality and risk of bias was performed using an adapted version of the Guidelines for Reporting Reliability and Agreement Studies. Results: Of the 1,541 studies retrieved, 5 were included in the review. All studies were observational cohort studies published between 2014 and 2020. The IOR of the Paris classification was moderate amongst all four studies evaluating colorectal neoplasms (range, κ = 0.42 to κ = 0.54) and substantial in one study that evaluated gastric neoplasms (κw = 0.65). An educational intervention was conducted by three studies with variable methodology and no significant change in IOR. Conclusions: IOR of the Paris classification is moderate for superficial colonic neoplasms. Further study is needed to determine the reliability of this system for superficial gastric lesions. Standardized training programs are required to investigate the impact of educational intervention on the Paris classification amongst endoscopists.

How to make cost-effective polyp simulators for high-fidelity simulation-based training in postpolypectomy bleeding management and EMR.

Video 1Demonstration of manufacturing instructions and features of the postpolypectomy bleeding and conventional and underwater EMR simulators.