Pure Cut or Endocut for Biliary Sphincterotomy? A Multicenter Randomized Clinical Trial.

INTRODUCTION: Adverse events (AE) after endoscopic retrograde cholangiopancreatography (ERCP) are not uncommon and post-ERCP acute pancreatitis (PEP) is the most important one. Thermal injury from biliary sphincterotomy may play an important role and trigger PEP or bleeding. Therefore, this study evaluated the outcomes of 2 electric current modes used during biliary sphincterotomy. METHODS: From October 2019 to August 2021, consecutive patients with native papilla undergoing ERCP with biliary sphincterotomy were randomized to either the pure cut or endocut after cannulation. The primary outcome was PEP incidence. Secondary outcomes included intraprocedural and delayed bleeding, infection, and perforation. RESULTS: A total of 550 patients were randomized (272 pure cut and 278 endocut). The overall PEP rate was 4.0% and significantly higher in the endocut group (5.8% vs 2.2%, P = 0.034). Univariate analysis revealed >5 attempts ( P = 0.004) and endocut mode ( P = 0.034) as risk factors for PEP. Multivariate analysis revealed >5 attempts ( P = 0.005) and a trend for endocut mode as risk factors for PEP ( P = 0.052). Intraprocedural bleeding occurred more often with pure cut ( P = 0.018), but all cases were controlled endoscopically during the ERCP. Delayed bleeding was more frequent with endocut ( P = 0.047). There was no difference in perforation ( P = 1.0) or infection ( P = 0.4999) between the groups. DISCUSSION: Endocut mode may increase thermal injury leading to higher rates of PEP and delayed bleeding, whereas pure cut is associated with increased intraprocedural bleeding without clinical repercussion. The electric current mode is not related to perforation or infection. Further RCT assessing the impact of electric current on AE with overlapping preventive measures such as rectal nonsteroidal anti-inflammatory drugs and hyperhydration are needed. The study was submitted to the Brazilian Clinical Trials Platform ( http://www.ensaiosclinicos.gov.br ) under the registry number RBR-5d27tn.

Colonoscopic Ultrasound-Guided Fine-Needle Aspiration Using a Curvilinear Array Transducer: A Single-Center Retrospective Cohort Study.

BACKGROUND: Curvilinear array ultrasound transducers enable tissue sampling and have therapeutic capabilities. Nevertheless, colonic intubation and maneuvering with these transducers is technically challenging and is therefore typically limited to the rectosigmoid area. This retrospective cohort study aimed to evaluate the safety, feasibility, and diagnostic yield of colonoscopic ultrasound-guided fine-needle aspiration in deep colonic intubation. IMPACT OF INNOVATION: The impact of this innovation is to enable tissue sampling of colonic and extracolonic lesions guided by endoscopic ultrasound. TECHNOLOGY, MATERIALS, AND METHODS: Curvilinear array ultrasound is used in the evaluation of luminal and extraluminal colonic diseases. Thirteen patients underwent colonoscopic ultrasound with a curvilinear array ultrasound endoscope in a single center for subepithelial lesions, cancer staging, and extracolonic lesions from July 2015 to February 2021. Endosonography was performed using an Olympus EU-ME1 and GF-UCT 180 with a 5-12MHz curvilinear array transducer. The primary outcome was the percentage of patients who were successfully scanned with the endoscopic ultrasound. The secondary outcomes included the success rate of fine-needle aspiration, the diagnostic yield of the tissue samples, and the adverse events related to the procedure. PRELIMINARY RESULTS: A total of 13 female patients underwent colonoscopic ultrasound. All patients (100%, 13/13) were successfully scanned. Fine-needle aspiration was deemed necessary and successfully performed in 100% (5/5) of the patients. Tissue samples collected by fine-needle aspiration resulted in a diagnostic yield of 60%, and no adverse events resulted from this intervention. CONCLUSIONS: This study demonstrates the feasibility of performing colonoscopic ultrasound with a curvilinear array transducer. Fine-needle aspiration for subepithelial, colonic, and extracolonic lesions is feasible and safe in this setting with no adverse events reported in our study. FUTURE DIRECTIONS: Future research should be directed toward validating colonoscopic ultrasound with a curvilinear array transducer technique in prospective randomized trials. Studies evaluating the feasibility and safety of endoscopic ultrasound-guided interventions in the colon, such as abscess drainage and enteral anastomosis, should be considered.

Suction versus slow-pull for endoscopic ultrasound-guided fine-needle aspiration of pancreatic tumors: a prospective randomized trial.

BACKGROUND: Suction (S) is commonly used to improve cell acquisition during endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). Slow-pull (SP) sampling is another technique that might procure good quality specimens with less bloodiness. We aimed to determine if SP improves the diagnostic yield of EUS-FNA of pancreatic masses. METHODS: Patients with pancreatic solid masses were randomized to four needle passes with both techniques in an alternate fashion. Sensitivity, specificity, positive, and negative predictive values were calculated. Cellularity and bloodiness of cytological samples were assessed and compared according to the technique. RESULTS: Sensitivity, specificity, and accuracy of suction vs. SP were 95.2% vs. 92.3%; 100% vs. 100; 95.7% vs. 93%, respectively. As to the association of methods, they were 95.6, 100 and 96%, respectively. Positive predictive values for S and SP were 100%. There was no difference in diagnostic yield between S and SP (p = 0.344). Cellularity of samples obtained with SP and Suction were equivalent in both smear evaluation (p = 0.119) and cell-block (0.980). Bloodiness of SP and suction techniques were similar as well. CONCLUSIONS: S and SP techniques provide equivalent sensitivity, specificity, and accuracy. Association of methods seems to improve diagnostic yield. Suction does not increase the bloodiness of samples compared to slow-pull.

Ex vivos models to teaching therapeutic endoscopic ultrasound (T-EUS).

BACKGROUND: Endoscopic ultrasound training has a learning curve greater than the other endoscopic therapeutic techniques. One of the preclinical teaching methods is the use of ex vivo porcine models. AIM: To describe five ex vivo porcine models for training in therapeutic echoendoscopic procedures. MATERIALS AND METHODS: Using porcine digestive tract containing esophagus, stomach, duodenum, spleen, liver and gallbladder, five models for therapeutic echoendoscopy training were described. With other segments of the porcine pieces (such as the bladder, spleen segment and omentum segment) and with easily accessible materials (such as grape and ultrasound gel), lesions were simulated to be treated. These models were applied in the Hands on course at the IRCAD (Institut de recherche contre les cancers de l'appareil digestif) Barretos of 2017. Endoscopic equipment and instruments are the same as those used in clinical practice. RESULT: The models are easily reproducible and do not require exchange during the hands on course period. Endoscopic and echographic imaging and tactile sensitivity are similar to the real one. CONCLUSION: The models described in this study demonstrated to be realistic, easy to reproduce and allow repetition during the same session. However, comparative studies are necessary to verify the real impact on teaching.

Guide wire-a sisted cannulation versus conventional contrast to prevent pancreatitis. A systematic review and meta-analysis based on randomized control trials.

OBJECTIVE: Through this systematic review and meta-analysis, we aim to clarify the differences between these two techniques, thus improving primary success cannulation and reducing complications during endoscopic retrograde cholangiopancreatography, primarily pancreatitis. METHODS: A comprehensive search was conducted to search for data available up until June2015from the most important databases available in the health field: EMBASE, MEDLINE (via PubMed), Cochrane, LILACS and CENTRAL (via BVS), SCOPUS, the CAPES database (Brazil), and gray literature. RESULTS: Nine randomized clinical trialsincluding2583 people were selected from20,198 studies for meta-analysis. Choledocholithiasis had been diagnosed in mostly (63.8%) of the patients, who were aged an average of 63.15 years. In those patients treated using the guide wire-assisted cannulation technique, provided a significantly lower instance of pancreatitis (RD=0.03; 95% CI: 0.01-0.05; I2= 45%) and greater primary success cannulation (RD=0.07; 95% CI: 0.03-0.12; I2=12%) than conventional contrast cannulation. CONCLUSIONS: The guide wire-assisted technique, when compared to the conventional contrast technique, reduces the risk of pancreatitis and increases primary success cannulation rate. Thus, guide wire-assisted cannulation appears to be the most appropriate first-line cannulation technique.

Ex vivo and simulator models teaching therapeutic ERCP and EUS: description of SOBED's first course.

Teaching models in endoscopy are important tools to minimize risks derived from endoscopic procedures, taking into account that therapeutic endoscopy, also known as surgical endoscopy, has greatly developed during the last decade. This results from the fact that minimally invasive procedures present relevant contributions and promote more comfort to patients. In this context, ex vivo teaching models and virtual simulators are important tools to the safe acquisition of abilities. In this article, the Brazilian Society of Digestive Endoscopy presents and describes its first course of therapeutic ERCP and EUS in models of laboratory teaching.

Productivity loss by cancer stage in patients newly diagnosed with hepatocellular carcinoma: A claims database analysis.

BACKGROUND: New cancer diagnoses are associated with employment decrease, workplace absenteeism, and attributable costs to employers. OBJECTIVE: To estimate the workplace productivity loss in the year following a new diagnosis of early-, intermediate-, or advanced-stage hepatocellular carcinoma (HCC) in commercially insured US adults. METHODS: We conducted a retrospective cohort study using Merative MarketScan commercial claims to identify incident HCC diagnoses from 2010 to 2020. Patients were stratified into early-, intermediate-, or advanced-stage cohorts based on presence of secondary malignancy codes or first treatment received. Mean workdays lost and attributable cost in the year following a new diagnosis were calculated using the Kaplan-Meier sample averages to account for censoring. An exploratory analysis was conducted on subgroups in the early and advanced cohorts to assess productivity loss in patients with and without treatment. RESULTS: Mean workdays lost in the year following a new HCC diagnosis among the early, intermediate, and advanced cohorts was 22.6 days (95% CI = 16.0-29.8), 17.4 days (95% CI = 11.9-23.2), and 19.5 days (95% CI = 15.6-23.6), respectively. Corresponding indirect costs were $6,031(95% CI = $4,270-$7,953), $4,644 (95% CI = $3,176-$6,192), and $5,204 (95% CI = $4,163-$6,298). Early-stage patients without a liver transplant and advanced-stage patients who received systemic therapy had 19.7 (95% CI = 12.7-27.4) and 22.0 (95% CI = 16.6-27.7) mean workdays lost, respectively. CONCLUSIONS: Productivity loss varies by stage and appears to be higher in early-stage patients who receive more intensive treatments in the first year following a new HCC diagnosis.

Why Liver Cancer Hits Home: Bridging Healthcare Disparities in the Asian American and Pacific Islander Community.

Asian Americans and Pacific Islanders have an increased risk of developing liver cancer and higher risk of death compared to non-Hispanic White individuals. The role of individual-level risk factors, social determinants of health, and barriers navigating health systems present unique challenges in obtaining liver cancer care for these patients. Additionally, the Asian American and Pacific Islander population is a heterogenous group originating from several different countries and speaking various languages, and they are often underrepresented in cancer clinical trial populations. This article describes the challenges faced by Asian American and Pacific Islander patients with liver cancer from the clinician, research, and patient advocacy perspectives and proposes targeted solutions to reduce healthcare disparities in this group.

Health care costs and resource use of managing hemophilia A: A targeted literature review.

BACKGROUND: Hemophilia A (HA) is a rare, inherited, serious bleeding disorder characterized by a deficiency of blood clotting factor VIII (FVIII). HA is associated with considerable economic burden. OBJECTIVE: To identify, review, and summarize published studies on the health care resource use and costs of managing HA in the United States using a targeted literature review. METHODS: A comprehensive and targeted literature search was conducted in Embase, MEDLINE, and Cochrane Database of Systematic Reviews covering the period 2010 to 2022. We supplemented the search by searching gray literature (relevant abstracts, posters, and presentations of relevant scientific conferences from the past 6 years [2016 to 2022], reference lists, the Institute for Clinical and Economic Review reports, and other sources). Eligibility criteria were developed based on the population, interventions, comparators, and outcomes framework. For comparability, costs were adjusted to 2021 US dollars. RESULTS: A total of 40 publications, including 17 full-text papers, 21 abstracts, and 2 Institute for Clinical and Economic Review reports, met eligibility criteria. Total annual health care costs per patient ranged from $213,874 to $869,940 and are mainly driven by the cost and intensity of prophylaxis with FVIII replacement concentrates, bypassing agents, and, most recently, emicizumab. Generally, we observed substantial heterogeneity in estimated treatment costs for HA, which varied depending on HA severity, treatment type and intensity, age, weight, and inhibitor status. Patients with inhibitors incurred much higher costs, but annual FVIII treatment costs are increasing over time among a subset of adult patients without inhibitors. Only 2 studies reported indirect costs; these were $13,220 and $27,978 annually among patients without and with inhibitors, respectively. Parents of children with HA spent $8,252 on non-mental health services and $258 on mental health services annually. CONCLUSIONS: The annual health care costs of managing HA are substantial and vary widely, depending on the study population definitions and intensity of prophylaxis. Total health care costs are dominated by the cost of prophylaxis. Indirect costs are also important. More robust studies in various settings, subpopulations, and assessing the impact of emerging therapies are required to fully elucidate the changing societal and economic impact, particularly regarding indirect costs and productivity loss for individuals living with HA. DISCLOSURES: Drs Solari and Thornhill are employees of Spark Therapeutics and Roche Group Shareholders. Ms Chen and Drs Cheng and Sullivan are employees of Curta, Inc. Spark Therapeutics paid Curta, Inc., to conduct the literature search. This study was funded by Spark Therapeutics. Spark Therapeutics was involved in the study design, collection, analysis and interpretation of data, article review, and the decision to submit the report for publication. Medical writing support was provided by Ashfield MedComms, an Inizio company.

Endoscopic Ultrasound View of Pneumatosis Cystoides Intestinalis.

Pneumatosis cystoid intestinalis (PCI) is a rare condition, with a worldwide incidence of 0.3-1.2%. PCI is classified into primary (idiopathic) and secondary forms, with 15% and 85% of presentations, respectively. This pathology was associated with a wide variety of underlining etiologies to explain the abnormal accumulation of gas within the submucosa (69.9%), subserosa (25.5%), or both layers (4.6%). Many patients endure misdiagnosis, mistreatment, or even inadequate surgical exploration. In this case, a patient presented acute diverticulitis, after treatment, a control colonoscopy was performed that found multiple rounds and elevated lesions. To further study the subepithelial lesion (SEL), a colorectal endoscopic ultrasound (EUS) was performed with an overtube in the same procedure. For safe insertion of the curvilinear array EUS, an overtube with colonoscopy was positioned through the sigmoid as described by Cheng et al. The EUS evaluation evidenced air reverberation in the submucosal layer. The pathological analysis was consistent with PCI's diagnosis. The diagnosis of PCI is usually made by colonoscopy (51.9%), surgery (40.6%), and radiological findings (10.9%). Although the diagnosis can be made by radiological studies, a colorectal EUS and colonoscopy can be made in the same section without radiation and with high precision. As it is a rare disease, there are not enough studies to define the best approach, although colorectal EUS should be preferred for a reliable diagnosis.

Self-Expandable Metal Stent (SEMS) Versus Lumen-Apposing Metal Stent (LAMS) for Drainage of Pancreatic Fluid Collections: A Randomized Clinical Trial.

Background and aim Endoscopic ultrasound (EUS)-guided drainage is the gold standard approach for the treatment of encapsulated pancreatic collections (EPCs) including pseudocyst and walled-off pancreatic necrosis (WON), and is associated with an equivalent clinical efficacy to surgical drainage with fewer complications and less morbidity. Drainage may be achieved via several types of stents including a fully covered self-expandable metallic stent (SEMS) and lumen-apposing metal stent (LAMS). However, to date there have been no randomized trials to compare these devices. This study aimed to compare the efficacy and safety of the SEMS versus LAMS for EUS-guided drainage of EPCs. Methods A phase IIB randomized trial was designed to compare the SEMS versus LAMS for the treatment of EPCs. Technical success, clinical success, adverse events (AEs), and procedure time were evaluated. A sample size of 42 patients was determined. Results There was no difference between the two groups in technical (LAMS 80.95% vs 100% SEMS, p=0.107), clinical (LAMS 85.71% vs 95.24% SEMS, p=0.606) or radiological success (LAMS 92.86% vs 83.33% SEMS, p=0.613). There was no difference in AEs including stent migration rate and mortality. The procedure time was longer in the LAMS group (mean time 43.81 min versus 24.43 min, p=0.001). There was also a difference in the number of intra-procedure complications (5 LAMS vs 0 SEMS, p=0.048). Conclusion SEMS and LAMS have similar technical, clinical, and radiological success as well as AEs. However, SEMS has a shorter procedure time and fewer intra-procedure complications compared to non-electrocautery-enhanced LAMS in this phase IIB randomized controlled trial (RCT). The choice of the type of stent used for EUS drainage of EPCs should consider device availability, costs, and personal and local experience.

Use of geriatric assessment in cancer clinical trials: A systematic review.

BACKGROUND: Older adults are underrepresented in cancer clinical trials despite accounting for most of the disease burden. Geriatric assessment (GA) could be used in clinical trials of cancer drugs for older adults to improve the clinical evidence for cancer drug use among older adults. OBJECTIVE: To examine patterns of use of GA in cancer clinical trials. METHODS: We undertook a systematic review of the studies reporting use of GA in a clinical trial setting for all cancer types and published between January 2010 and January 2020. Characteristics of GA use were extracted for each study, along with study phase, cancer type, and participant age (PROSPERO: CRD42020170584). RESULTS: We identified 320 studies and 63 studies met the final inclusion criteria. Among 74 purposes of GA use, the most common was to examine the association between impairments in GA domains and clinical outcomes (28/74, 38%). Among 258 GA domains assessed across 63 studies, physical status (59/258, 23%) and comorbidities (50/258, 19%) were most often evaluated. There was significant heterogeneity in the instruments used to assess physical function (n = 16) and mood disorders (n = 7). Most studies were phase 2 (32/63, 51%). CONCLUSIONS: GA is most often used in clinical trial settings to examine associations between GA-identified deficits and clinical outcomes. Significant heterogeneity exists in the GA instruments used across trials. Comprehensive and consistent incorporation of GA into future cancer clinical trial designs could help collect more older adult-specific clinical information and adjust trial eligibility criteria to increase representation by older adults.

Anti-reflux versus conventional self-expanding metal stents in the palliation of esophageal cancer: A systematic review and meta-analysis.

Background and study aims Self-expanding metal stents (SEMS) are an effective palliative endoscopic therapy to reduce dysphagia in esophageal cancer. Gastroesophageal reflux disease (GERD) is a relatively common complaint after non-valved conventional SEMS placement. Therefore, valved self-expanding metal stents (SEMS-V) were designed to reduce the rate of GERD symptoms. We aimed to perform a systematic review and meta-analysis comparing the two stents. Material and methods This was a systematic review and meta-analysis including only randomized clinical trials (RCT) comparing the outcomes between SEMS-V and non-valved self-expanding metal stents (SEMS-NV) following the Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines. The risk of bias was assessed using the Cochrane Risk of Bias 2 tool. Data were analyzed with Review Manager Software. Quality of evidence was evaluated using Grading of Recommendations Assessment, Development, and Evaluation guidelines. Results Ten randomized clinical trials including a total of 467 patients, 234 in the SEMS-V group and 233 in the SEMS-NV group, were included. There were no statistically significant differences regarding GERD qualitative analysis (RD -0.17; 95 % CI -0.67, 0.33; P  = 0.5) and quantitative analysis (SMD -0.22; 95 % CI -0.53, 0.08; P  = 0.15) technical success (RD -0.03; 95 % CI -0.07, 0.01; P  = 0.16), dysphagia improvement (RD -0.07; 95 % CI -0.19, 0.06; P  = 0.30), and adverse events (RD 0.07; 95 % CI -0.07, 0.20; P  = 0.32). Conclusions Both SEMS-V and SEMS-NV are safe and effective in the palliation of esophageal cancer with similar rates of GERD, dysphagia relief, technical success, adverse events, stent migration, stent obstruction, bleeding, and improvement of the quality of life.

Pancreatitis after endoscopic retrograde cholangiopancreatography: A narrative review.

Acute post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is a feared and potentially fatal complication that can be as high as up to 30% in high-risk patients. Pre-examination measures, during the examination and after the examination are the key to technical and clinical success with a decrease in adverse events. Several studies have debated on the subject, however, numerous topics remain controversial, such as the effectiveness of prophylactic medications and the amylase dosage time. This review was designed to provide an update on the current scientific evidence regarding PEP available in the literature.