BACKGROUND AND AIMS:Endoscopic ultrasound-guided choledochoduodenostomy with a lumen apposing metal stent (EUS-CDS-L) is an increasingly utilized therapeutic option for biliary drainage. However, numerous procedural and periprocedural factors may influence technical and clinical outcomes. The aim of this study was to develop an expert consensus on key recommendations for EUS-CDS-L. METHODS:Thirty-two international experts in EUS-CDS-L contributed to this Delphi process over two rounds by voting anonymously on 28 statements using a five-point Likert scale. Statements were accepted in the first round or revised in the second round based on an agreement level of ≥ 80%, with a median ≥ 4, and an interquartile range (IQR) ≤ 1. RESULTS:28 statements were initially circulated, 2 were removed, and 26 were considered for final consensus. A consensus was achieved for 24 of 26 (92.3%) statements after two voting rounds across the three domains, with the first focusing on indications: (1) the preference for EUS-CDS-L in distal malignant biliary obstruction (DMBO) without gastric outlet obstruction (GOO); (2) the inclusion of EUS-CDS-L as a therapeutic option in benign biliary obstruction, and (3) the performance of EUS-CDS-L in patients scheduled for upfront surgery. A second domain focused on procedural considerations: (1) the preferred cutoff of common bile duct (CBD) diameter for safe EUS-CDS-L, and (2) the lack of evidence for antibiotic prophylaxis, and several technical steps in the recommended deployment process. CONCLUSION:This modified Delphi consensus provides international expert panel agreement on several key aspects of EUS-CDS-L, while also highlighting areas that require further research.
Background: The European Society of Gastrointestinal Endoscopy (ESGE) and British Society of Gastroenterology (BSG) formulated performance measures to improve the detection rate of upper gastrointestinal (UGI) endoscopy. We aimed to assess the adherence to and impact of a training on adherence to performance measures for UGI endoscopy. Methods: In this multicentre prospective cohort study, endoscopists of three centres underwent a 1-hour face-to-face training based on ESGE and BSG procedural performance measures (≥7 minutes inspection time; photodocumentation of ≥10 anatomical landmarks + abnormalities; standardized terminology; biopsy protocols). A self-developed quality assessment score was used to assess diagnostic UGI endoscopies before (control group) and after (intervention group) training. Primary endpoint was improvement in overall quality score (percentage of the maximum score). Results: Of 1,733 consecutive UGI endoscopies, 570 were eligible for inclusion (mean patient age 60 yrs (SD 15); male 47%): 285 in the control group and 285 in the intervention group. Overall quality score increased from 60% before to 67% after the training intervention (difference 7%, 95% CI 5 – 10, p<0.001). Male patients (3.2%, 95% CI 0.7 – 5.7), alarming features (-3.1%, 95% CI -5.6 – -0.5), and age of endoscopists (-0.4% increment per year, 95% CI -0.8 – -0.1) were associated with higher quality scores. Conclusion: Adherence to the procedural ESGE and BSG performance measures for UGI endoscopy persistently increased after a 1-hour face-to-face training intervention, suggesting that a simple training intervention tool can improve the quality of UGI endoscopy and potentially could prevent missed lesions.
Background and study aims Endoscopic mucosal resection (EMR) is a safe and minimally invasive procedure to remove colorectal non-pedunculated polyps. Recurrence rates are relatively high and differ among endoscopists. We aimed to evaluate whether endoscopists are able to predict recurrence based on thorough inspection of images of mucosal defects after an assumed complete EMR. Methods We developed an online survey in which endoscopists were invited to indicate whether they expected recurrence to develop when inspecting 30 post-EMR defect images. All EMRs were considered to be complete resections by the performing endoscopist. Participating endoscopists were scored based on the number of correct answers regarding presence or absence of recurrence found at first surveillance colonoscopy. Results A total of 140 endoscopists responded to the survey (response rate 25%). A total of 124 respondents with a mean age of 46.5 years evaluated the 30 images. The overall score in the cohort was 70%, indicating that respondents were able to correctly predict recurrence in three-quarters of cases with an overall level of certainty of 53.4%. When comparing results of experienced and less experienced endoscopists based on the number of endoscopic submucosal dissections and/or EMRs performed yearly, no difference (71% versus 69%, P = 0.23) was found. Conclusions This study shows that recurrences after presumed complete EMR can reasonably well be predicted by both experienced and less experienced endoscopists when evaluating images with mucosal defects. Thorough inspection of the post-EMR defect may reduce recurrence rates by recognizing and subsequent treatment of suspect areas.
Non-ampullary duodenal polyps account for a group of rare tumors of the gastrointestinal tract. Although small lesions are relatively easy to remove, resection of larger lesions requires more advanced techniques such as endoscopic mucosal resection (EMR). Although this technique is considered safe, the most prevalent complication is delayed bleeding (DB) with considerable incidence rates of up to 26%. In this study, we aimed to assess whether prophylactic clipping (PC) reduces DB rates after EMR of large duodenal non-ampullary lateral spreading lesions. We retrospectively collected data from consecutive duodenal EMRs of non-ampullary lateral spreading lesions ≥ 15 mm performed between 2019 and 2022 at two medical centers in the Netherlands and Germany. A total of 186 polyps with a mean size of 25 mm were included in this study. Most were tubular adenomas (55%) and contained low-grade dysplasia (84%). PC of the resection site was performed in 84 patients (45%). The overall DB rate was 13% (24/186). DB occurred in three of 84 cases with PC versus 21 of 102 cases without PC (4% versus 21%, P < 0.01). With an odds ratio of 0.22, multivariable analysis indicated that PC significantly reduced DB (95% confidence interval 0.06–0.85; P = 0.03). PC of the resection site significantly reduced DB after EMR of large non-ampullary duodenal lateral spreading lesions.
Background and study aims Patients with symptomatic cholelithiasis can be stratified according to the 2019 European Society for Gastrointestinal Endoscopy (ESGE) guideline into low-, intermediate- and high-likelihood groups for presence of choledocholithiasis. For the intermediate group, endoscopic ultrasound (EUS) or magnetic resonance cholangiopancreatography (MRCP) is recommended to assess whether an endoscopic retrograde cholangiopancreatography (ERCP) is necessary prior to cholecystectomy. The aim of the study was to investigate adherence to the guideline for diagnostic and treatment strategy for cholelithiasis in daily clinical practice. Patients and methods A multicenter, retrospective cross-sectional observational study of the diagnostic pathway of patients with suspicion of choledocholithiasis was conducted between 2019 and 2021. Patients were stratified according to the ESGE guideline "Endoscopic management of common bile duct stones". Results A total of 305 patients were included in the analysis and stratified into low- (17%), intermediate- (40%) and high- (43%) likelihood of choledocholithiasis. In these three categories, 182 patients (60%) underwent ERCP. Adherence to the ESGE guideline recommendation was 59.7% overall and was the highest in the intermediate-likelihood group (83.6%), compared with 45.1% in the low- and 43.2% in the high-likelihood group, respectively ( P < 0.001). In the high-likelihood group, 49% underwent additional imaging. In 195 patients who underwent additional imaging, 55 ERCPs (28.2%) could be avoided. Conclusions This study shows that stratification according to the ESGE guideline is useful to reduce the number of unnecessary additional imaging procedures and ERCPs in patients with a suspicion of choledocholithiasis. It seems worthwhile to perform EUS prior to ERCP in the same session.
INTRODUCTION:Screening for early esophageal adenocarcinoma (EAC) may potentially reduce EAC-related mortality and morbidity. This study aimed to examine the Dutch population's intended uptake of 3 hypothetical EAC screening test scenarios and preferences for potential future organization. METHODS:A total of 8,350 Dutch individuals aged 45-75 years were invited, of whom 2,258 completed a web-based survey. Participants were randomly assigned to 1 of 3 hypothetical screening test scenarios (i.e., transnasal endoscopy, ingestible cell collection device, or breath analysis). The primary outcome was intended uptake. Secondary outcomes included acceptance of screening eligibility criteria and preferences regarding invitation, counseling, and diagnostic follow-up. We performed exploratory univariable and multivariable regression analyses to assess which determinants were associated with EAC screening intent. RESULTS:Intended uptake of screening was highest in the breath analysis scenario (95%), followed by conventional upper endoscopy (78%), an ingestible cell collection device (75%), and transnasal endoscopy (68%) ( P < 0.001). Anticipating discomfort was most strongly associated with decreased intention to undergo transnasal endoscopy (odds ratio 0.18, 95% confidence interval 0.11-0.29) or swallow a cell collection device (odds ratio 0.20, 95% confidence interval 0.13-0.32). Cancer worry and high acceptance of test sensitivity/specificity were consistently associated with a positive intention to participate in screening. Inviting persons for screening based on gastroesophageal reflux disease symptoms, age, or the output of a risk prediction model was acceptable to 74%, 69%, and 66%, respectively. Inviting only men was acceptable for only 41% of women. The majority (58%) preferred to be invited by a public health organization, and 32% of the participants preferred to discuss their decision to participate with a healthcare professional. DISCUSSION:Participants in this study self-selected through a web-based survey, potentially introducing selection bias. Participants generally intended to participate in EAC screening, although the level of intent depended on the discomfort and performance associated with the offered screening test. Determining eligibility based on gastroesophageal reflux disease symptoms, age, or a risk calculator, but not sex, would be acceptable to most individuals.
BACKGROUND:Diffuse type adenocarcinoma and, more specifically, signet ring cell carcinoma (SRCC) of the stomach and gastroesophageal junction (GEJ) have a poor prognosis and the value of neoadjuvant chemo(radio)therapy (nCRT) is unclear. METHODS:All patients who underwent surgery for diffuse type gastric and GEJ carcinoma between 2004 and 2015 were retrospectively included from the Netherlands Cancer Registry. The primary outcome was overall survival after surgery. Kaplan-Meier curves were plotted. Furthermore, multivariable Poisson and Cox regressions were performed, correcting for confounders. To comply with the Cox regression proportional hazard assumption, gastric cancer survival was split into two groups, i.e. <90 days and >90 days, postoperatively by adding an interaction variable. RESULTS:Analyses included 2046 patients with diffuse type cancer: 1728 gastric cancers (50% SRCC) and 318 GEJ cancers (39% SRCC). In the gastric cancer group, 49% received neoadjuvant chemotherapy (nCT) and 51% received primary surgery (PS). All-cause mortality within 90 days postoperatively was lower after nCT (hazard ratio [HR] 0.29, 95% confidence interval [CI] 0.20-0.44; p < 0.001). Also after 90 days, mortality was lower in the nCT group (HR for the interaction variable 2.84, 95% CI 1.87-4.30, p < 0.001; total HR 0.29*2.84 = 0.84). In the GEJ group, 38% received nCT, 22% received nCRT, and 39% received PS. All-cause mortality was lower after nCT (HR 0.63, 95% CI 0.43-0.93; p = 0.020) compared with PS. The nCRT group was removed from the Cox regression analysis since the Kaplan-Meier curves of nCRT and PS intersected. The results for gastric and GEJ carcinomas were similar between the SRCC and non-SRCC subgroups. CONCLUSION:For gastric and GEJ diffuse type cancer, including SRCC, nCT was associated with increased survival.
BACKGROUND:Modifying public awareness of oesophageal cancer symptoms might help to decrease late-stage diagnosis and, in turn, improve cancer outcomes. This study aimed to explore oesophageal cancer symptom awareness and determinants of lower awareness and anticipated time to help-seeking. METHODS:We invited 18,156 individuals aged 18 to 75 years using random sampling of the nationwide Dutch population registry. A cross-sectional web-based survey containing items adapted from the Awareness and Beliefs about Cancer measure (i.e., cancer symptom awareness, anticipated time to presentation with dysphagia, health beliefs, and sociodemographic variables) was filled out by 3106 participants (response rate: 17%). Descriptive statistics were calculated and logistic regression analyses were performed to explore determinants of awareness and anticipated presentation (dichotomised as <1 month or ≥1 month). RESULTS:The number of participants that recognised dysphagia as a potential symptom of cancer was low (47%) compared with symptoms of other cancer types (change in bowel habits: 77%; change of a mole: 93%; breast lump: 93%). In multivariable analyses, non-recognition of dysphagia was associated with male gender (OR 0.50, 95% CI 0.43-0.58), lower education (OR 0.44, 0.35-0.54), and non-western migration background (OR 0.43, 0.28-0.67). Anticipated delayed help-seeking for dysphagia was associated with not recognising it as possible cancer symptom (OR 1.58, 1.27-1.97), perceived high risk of oesophageal cancer (OR 2.20, 1.39-3.47), and negative beliefs about oesophageal cancer (OR 1.86, 1.20-2.87). CONCLUSION:Our findings demonstrate a disconcertingly low public awareness of oesophageal cancer symptoms. Educational interventions targeting groups with decreased awareness and addressing negative cancer beliefs may lead to faster help-seeking behaviour, although additional studies are needed to determine the effect on clinical cancer outcomes.
Background Studies on the effect of computer-aided detection (CAD) in a daily clinical screening and surveillance colonoscopy population practice are scarce. The aim of this study was to evaluate a novel CAD system in a screening and surveillance colonoscopy population. Methods This multicentre, randomised, controlled trial was done in ten hospitals in Europe, the USA, and Israel by 31 endoscopists. Patients referred for non-immunochemical faecal occult blood test (iFOBT) screening or surveillance colonoscopy were included. Patients were randomomly assigned to CAD-assisted colonoscopy or conventional colonoscopy; a subset was further randomly assigned to undergo tandem colonoscopy: CAD followed by conventional colonoscopy or conventional colonoscopy followed by CAD. Primary objectives included adenoma per colonoscopy (APC) and adenoma per extraction (APE). Secondary objectives included adenoma miss rate (AMR) in the tandem colonoscopies. The study was registered at ClinicalTrials.gov, NCT04640792. Findings A total of 916 patients were included in the modified intention-to-treat analysis: 449 in the CAD group and 467 in the conventional colonoscopy group. APC was higher with CAD compared with conventional colonoscopy (0 center dot 70 vs 0 center dot 51, p=0 center dot 015; 314 adenomas per 449 colonoscopies vs 238 adenomas per 467 colonoscopies; poisson effect ratio 1 center dot 372 [95% CI 1 center dot 068-1 center dot 769]), while showing non-inferiority of APE compared with conventional colonoscopy (0 center dot 59 vs 0 center dot 66; p<0 center dot 001 for non-inferiority; 314 of 536 extractions vs 238 of 360 extractions). AMR in the 127 (61 with CAD first, 66 with conventional colonoscopy first) patients completing tandem colonoscopy was 19% (11 of 59 detected during the second pass) in the CAD first group and 36% (16 of 45 detected during the second pass) in the conventional colonoscopy first group (p=0 center dot 024). Interpretation CAD increased adenoma detection in non-iFOBT screening and surveillance colonoscopies and reduced adenoma miss rates compared with conventional colonoscopy, without an increase in the resection of nonadenomatous lesions. Funding Magentiq Eye. Copyright (c) 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license.
BACKGROUND:Recognition of submucosal invasive colorectal cancer (T1 CRC) is difficult, with sensitivities of 35 %-60 % in Western countries. We evaluated the real-life effects of training in the OPTICAL model, a recently developed structured and validated prediction model, in Dutch community hospitals. METHODS:In this prospective multicenter study (OPTICAL II), 383 endoscopists from 40 hospitals were invited to follow an e-learning program on the OPTICAL model, to increase sensitivity in detecting T1 CRC in nonpedunculated polyps. Real-life recognition of T1 CRC was then evaluated in 25 hospitals. Endoscopic and pathologic reports of T1 CRCs detected during the next year were collected retrospectively, with endoscopists unaware of this evaluation. Sensitivity for T1 CRC recognition, R0 resection rate, and treatment modality were compared for trained vs. untrained endoscopists. RESULTS:1 year after e-learning, 528 nonpedunculated T1 CRCs were recorded for endoscopies performed by 251 endoscopists (118 [47 %] trained). Median T1 CRC size was 20 mm. Lesions were mainly located in the distal colorectum (66 %). Trained endoscopists recognized T1 CRCs more frequently than untrained endoscopists (sensitivity 74 % vs. 62 %; mixed model analysis odds ratio [OR] 2.90, 95 %CI 1.54-5.45). R0 resection rate was higher for T1 CRCs detected by trained endoscopists (69 % vs. 56 %; OR 1.73, 95 %CI 1.03-2.91). CONCLUSION:Training in optical recognition of T1 CRCs in community hospitals was associated with increased recognition of T1 CRCs, leading to higher en bloc and R0 resection rates. This may be an important step toward more organ-preserving strategies.
Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication of ERCP, with limited studies comparing combined prophylactic measures and their efficacy relative to individual patient risk profiles. This study aims to perform an individual patient data meta-analysis (IPDMA) to evaluate the contribution of patient and ERCP-related risk factors to PEP development and to identify the best prophylaxis strategies according to the patient’s risk profile. We systematically searched MEDLINE, Embase, and Cochrane databases until November 2022 for randomized controlled PEP prophylaxis trials. We invited authors to share individual patient data, including PEP risk profile and prophylaxes used. PEP incidence rates for different prophylaxis were calculated. Efficacy was compared using multilevel logistic regression and expressed as relative risk (RR). Subgroup analysis evaluated the role of patient and ERCP-related risk factors in developing PEP. Data from 11 studies, including 6430 patients, were analyzed. After adjusting for risk factors, rectal NSAIDs (RR 0.69, 95
Background Nowadays, large benign lateral spreading lesions (LSLs) and sessile polyps in the colorectum are mostly resected by endoscopic mucosal resection (EMR). A major drawback of EMR is the polyp recurrence rate of up to 20%. Snare tip soft coagulation (STSC) is considered an effective technique to reduce recurrence rates. However, clinical trials on STSC have mainly been conducted in expert referral centers. In these studies, polyp recurrence was assessed optically, and additional adjunctive techniques were excluded. In the current trial, we will evaluate the efficacy and safety of STSC in daily practice, by allowing adjunctive techniques during EMR and the use of both optical and histological polyp recurrence to assess recurrences during follow-up. Methods The RESPECT study is a multicenter, parallel-group, international single blinded randomized controlled superiority trial performed in the Netherlands and Germany. A total of 306 patients undergoing piecemeal EMR for LSLs or sessile colorectal polyps sized 20–60 mm will be randomized during the procedure after endoscopic complete polyp resection to the intervention or control group. Post-EMR defects allocated to the intervention group will be treated with thermal ablation with STSC of the entire resection margin. Primary outcome will be polyp recurrence by optical and histological confirmation at the first surveillance colonoscopy after 6 months. Secondary outcomes include technical success and complication rates. Discussion The RESPECT study will evaluate if STSC is effective in reducing recurrence rates after piecemeal EMR of large colorectal lesions in daily clinical practice performed by expert and non-expert endoscopists. Moreover, endoscopists will be allowed to use adjunctive techniques to remove remaining adenomatous tissue during the procedure. Finally, adenomatous polyp recurrence during follow-up will be defined by histologic identification. Trial registration ClinicalTrials.gov NCT05121805. Registered on 16 November 2021. Start recruitment: 17 March 2022. Planned completion of recruitment: 31 April 2025.
Aims To develop and validate a new scale for mucosal visualization of the upper gastrointestinal tract during esophagogastroduodenoscopy (EGD), the Gastroscopy RAte of Cleanliness Evaluation (GRACE), as a quality standard tool through the application of a standardized, reliable, and validated scoring system.
Background Unnecessary D2-gastrectomy and associated costs can be prevented after detecting non-curable gastric cancer, but impact of staging on treatment costs is unclear. This study determined the cost impact of 18 F-fluorodeoxyglucose positron emission tomography/computed tomography ( 18F FDG-PET/CT) and staging laparoscopy (SL) in gastric cancer staging. Materials and Methods In this cost analysis, four staging strategies were modeled in a decision tree: (1) 18F FDG-PET/CT first, then SL, (2) SL only, (3) 18F FDG-PET/CT only, and (4) neither SL nor 18F FDG-PET/CT. Costs were assessed on the basis of the prospective PLASTIC-study, which evaluated adding 18F FDG-PET/CT and SL to staging advanced gastric cancer (cT3–4 and/or cN+) in 18 Dutch hospitals. The Dutch Healthcare Authority provided 18F FDG-PET/CT unit costs. SL unit costs were calculated bottom-up. Gastrectomy-associated costs were collected with hospital claim data until 30 days postoperatively. Uncertainty was assessed in a probabilistic sensitivity analysis (1000 iterations). Results 18F FDG-PET/CT costs were €1104 including biopsy/cytology. Bottom-up calculations totaled €1537 per SL. D2-gastrectomy costs were €19,308. Total costs per patient were €18,137 for strategy 1, €17,079 for strategy 2, and €19,805 for strategy 3. If all patients undergo gastrectomy, total costs were €18,959 per patient (strategy 4). Performing SL only reduced costs by €1880 per patient. Adding 18F FDG-PET/CT to SL increased costs by €1058 per patient; IQR €870–1253 in the sensitivity analysis. Conclusions For advanced gastric cancer, performing SL resulted in substantial cost savings by reducing unnecessary gastrectomies. In contrast, routine 18F FDG-PET/CT increased costs without substantially reducing unnecessary gastrectomies, and is not recommended due to limited impact with major costs. Trial registration : NCT03208621. This trial was registered prospectively on 30-06-2017.
Amsterdam UMC, location University of Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam, Netherlands; Amsterdam Gastroenterology Endocrinology Metabolism, Netherlands; Cancer Center Amsterdam, Netherlands; Radboud University Medical Center, Department of Gastroenterology and Hepatology, Netherlands; Leiden University Medical Center, Department of Surgery, Netherlands; Amsterdam UMC, location University of Amsterdam, Department of Surgery, Netherlands; Amsterdam UMC, location Vrije Universiteit, Department of Surgery, Netherlands; St Antonius Hospital, Department of Surgery, Netherlands; University Medical Center Utrecht, Department of Surgery, Netherlands; Onze Lieve Vrouwe Gasthuis, Department of Surgery, Netherlands; Leiden University Medical Center, Department of Gastroenterology and Hepatology, Netherlands; Onze Lieve Vrouwe Gasthuis, Department of Gastroenterology and Hepatology, Netherlands; Medisch Spectrum Twente, Department of Surgery, Netherlands; Erasmus University Medical Center, Department of Gastroenterology and Hepatology, Netherlands; Medisch Spectrum Twente, Department of Gastroenterology and Hepatology, Netherlands; University Medical Center Utrecht, Department of Gastroenterology and Hepatology, Netherlands; St Antonius Hospital, Department of Gastroenterology and Hepatology, Netherlands; Amsterdam UMC, location Vrije Universiteit, Department of Gastroenterology and Hepatology, Netherlands.
Fundoplication is a durable, effective, and well-accepted treatment for gastroesophageal reflux disease. Nonetheless, troublesome postoperative symptoms do occasionally occur with management varying widely among centers. In an attempt to standardize definition and management of postfundoplication symptoms, a panel of international experts convened by the Guidelines Committee of the International Society for Diseases of the Esophagus devised a list of 33 statements across 5 domains through a Delphi approach, with at least 80% agreement to establish consensus. Eight statements were endorsed for the domain of Definitions, four for the domain of Investigations, nine for Dysphagia, nine for Heartburn, and four for Revisional surgery. This consensus defined as the treatment goal of fundoplication the resolution of symptoms rather than normalization of physiology or anatomy. Required investigations of all symptomatic postfundoplication patients were outlined. Further management was standardized by patients' symptomatology. The appropriateness of revisional fundoplication and the techniques thereof were described and the role of revisional surgery for therapies other than fundoplication were assessed. Fundoplication remains a frequently-performed operation, and this is the first international consensus on the management of various postfundoplication problems.
BACKGROUND:Piecemeal endoscopic mucosal resection (EMR) is an acceptable technique for T1a esophageal adenocarcinoma, but en bloc R0 excision is advocated for T1b disease as it may offer a potential cure and mitigate recurrence. Thus, distinguishing between T1a and T1b disease is imperative under current treatment paradigms. We investigated whether expert Barrett's endoscopists could make this distinction based on optical evaluation. METHODS:Endoscopic images of histologically confirmed high grade dysplasia (HGD), T1a, and T1b disease (20 sets for each) were compiled from consecutive patients at a single institution. Each set contained four images including an overview, a close-up in high definition white light, a near-focus magnification image, and a narrow-band image. Experts predicted the histology for each set. RESULTS:19 experts from 8 countries (Australia, USA, Italy, Netherlands, Germany, Canada, Belgium, and Portugal) participated. The majority had been practicing for > 20 years, with a median (interquartile range) annual case volume of 50 (18-75) for Barrett's EMR and 25 (10-45) for Barrett's endoscopic submucosal dissection. Esophageal adenocarcinoma (T1a/b) could be distinguished from HGD with a pooled sensitivity of 89.1 % (95 %CI 84.7-93.4). T1b adenocarcinoma could be predicted with a pooled sensitivity of 43.8 % (95 %CI 29.9-57.7). Fleiss' kappa was 0.421 (95 %CI 0.399-0.442; P < 0.001), indicating fair-to-moderate agreement. CONCLUSIONS:Expert Barrett's endoscopists could reliably differentiate T1a/T1b esophageal adenocarcinoma from HGD. Despite fair-to-moderate agreement for T staging, T1b disease could not be reliably distinguished from T1a disease. This may impact clinical decision making and selection of endoscopic techniques.
Background and Aims: A novel multisegmented esophageal fully covered self-expandable metal stent (FCSEMS) was designed to reduce stent migration, which is seen in up to 30% of patients. The goal of this study was to evaluate the safety and efficacy fi cacy of the multisegmented FCSEMS. Methods: This multicenter prospective study aimed to include 30 patients undergoing palliative stent placement. Efficacy, fi cacy, defined fi ned as technically successful stent placement and dysphagia scores, and safety, defined fi ned as the number of adverse events (AEs) and serious AEs (SAEs), were measured. Results: The study was prematurely terminated due to safety concerns after including 23 patients (mean +/- standard deviation age, 72 +/- 10 years; 78% male). Stent placement was technically successful in 21 patients (91%), and dysphagia scores had improved in all patients with successful stent placement. SAEs were reported in 16 (70%) patients. Stent-related mortality occurred in 3 patients (13%). Conclusions: The multisegmented FCSEMS successfully treated malignant dysphagia. The study was prematurely terminated, however, because stent placement was associated with a relatively high SAE rate. (Clinical trial registration number: NCT04415463.) (Gastrointest Endosc 2024;99:1027-31.)
Cost-utility analysis typically relies on preference-based measures (PBMs). While generic PBMs are widely used, disease-specific PBMs can capture aspects relevant for certain patient populations. Here the EORTC QLU-C10D, a cancer-specific PBM based on the QLQ-C30, is validated using Dutch trial data with the EQ-5D-3L as a generic comparator measure. We retrospectively analysed data from four Dutch randomised controlled trials (RCTs) comprising the EORTC QLQ-C30 and the EQ-5D-3L. Respective Dutch value sets were applied. Correlations between the instruments were calculated for domains and index scores. Bland–Altman plots and intra-class correlations (ICC) displayed agreement between the measures. Independent and paired t-tests, effect sizes and relative validity indices were used to determine the instruments’ performance in detecting clinically known-group differences and health changes over time. We analysed data from 602 cancer patients from four different trials. In overall, the EORTC QLU-C10D showed good relative validity with the EQ-5D-3L as a comparator (correlations of index scores r = 0.53–0.75, ICCs 0.686–0.808, conceptually similar domains showed higher correlations than dissimilar domains). Most importantly, it detected 63
Endoscopic ultrasound (EUS) with fine needle aspiration or fine needle biopsy is the gold standard for sampling tissue to diagnose pancreatic cancer and autoimmune pancreatitis or to analyze cyst fluid. The most common reported adverse event of fine needle aspiration and/or fine needle biopsy is acute pancreatitis, which is likely induced by the same pathophysiological mechanisms as after endoscopic retrograde cholangiopancreatography (ERCP). According to the current European Society of Gastrointestinal Endoscopy guideline, nonsteroidal anti-inflammatory drugs are administered prior to ERCP as a scientifically proven treatment to reduce post-ERCP pancreatitis incidence rate. A single suppository of diclofenac or indomethacin prior to EUS guided tissue acquisition (TA) is harmless in healthy adults. Since it is associated with low costs and, most important, may prevent a dreadsome complication, we strongly recommend the administration of 100 mg diclofenac rectally prior to EUS-TA. We will explain this recommendation in more detail in this review as well as the risk and pathophysiology of post-EUS TA pancreatitis.