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Gastrointestinal endoscopy is largely dependent on medical devices. The European Union (EU) has recently introduced stricter rules and regulations for the approval of medical devices. This has consequences both for endoscopists and for patients. The new regulations increase the need for clinical trials and observational studies for new and current devices used in endoscopy to ensure clinical benefit and reduce patient harm. European endoscopy environments should facilitate industry-sponsored clinical trials and registry studies to meet the demand for robust data on endoscopic devices as required in the new legislation. The European Society of Gastrointestinal Endoscopy (ESGE) will play an active role in the establishment of the new system.The EU is establishing independent expert panels for device regulation in gastroenterology and hepatology, including endoscopy, that are charged with assessing the requirements for device testing. The ESGE encourages endoscopists with expertise in the technical and clinical performance of endoscopy devices to apply for expert panel membership. The ESGE has provided information for interested endoscopists on the ESGE website. Private European companies called “notified bodies” are entitled to conduct device approval for the EU. The ESGE will actively engage with these notified bodies for topics related to the new endoscopy device approval process to ensure continued access to high quality endoscopy devices for endoscopists in Europe.

Background Current surveillance for Barrett’s esophagus (BE), consisting of four-quadrant random forceps biopsies (FBs), has an inherent risk of sampling error. Wide-area transepithelial sampling (WATS) may increase detection of high grade dysplasia (HGD) and esophageal adenocarcinoma (EAC). In this multicenter randomized trial, we aimed to evaluate WATS as a substitute for FB. Methods Patients with known BE and a recent history of dysplasia, without visible lesions, at 17 hospitals were randomized to receive either WATS followed by FB or vice versa. All WATS samples were examined, with computer assistance, by at least two experienced pathologists at the CDx Diagnostics laboratory. Similarly, all FBs were examined by two expert pathologists. The primary end point was concordance/discordance for detection of HGD/EAC between the two techniques. Results 172 patients were included, of whom 21 had HGD/EAC detected by both modalities, 18 had HGD/EAC detected by WATS but missed by FB, and 12 were detected by FB but missed by WATS. The detection rate of HGD/EAC did not differ between WATS and FB (P = 0.36). Using WATS as an adjunct to FB significantly increased the detection of HGD/EAC vs. FB alone (absolute increase 10 % [95 %CI 6 % to 16 %]). Mean procedural times in minutes for FB alone, WATS alone, and the combination were 6.6 (95 %CI 5.9 to 7.1), 4.9 (95 %CI 4.1 to 5.4), and 11.2 (95 %CI 10.5 to 14.0), respectively. Conclusions Although the combination of WATS and FB increases dysplasia detection in a population of BE patients enriched for dysplasia, we did not find a statistically significant difference between WATS and FB for the detection of HGD/EAC as single modality.

Background Several techniques exist for the eradication of Barrett’s esophagus (BE); however, all have limitations regarding successful conversion to squamous epithelium and a complication profile. We aimed to assess the feasibility and safety of a new nonthermal device, the EndoRotor, for the eradication of BE as a first-line ablation technique. Methods Patients with BE were prospectively included at two tertiary referral centers in The Netherlands. Inclusion criteria: BE length 2–5 cm, with low grade dysplasia, high grade dysplasia, or residual BE after endoscopic resection (ER) of a lesion containing early neoplasia. Exclusion criteria: previous ER > 50 % circumference, or previous ablation therapy. Follow-up endoscopy was performed 3 months after ablation therapy. Outcomes were the percentage of endoscopically visible BE surface regression and complications. Results 30 patients were included (age 66 years, interquartile range [IQR] 59–73, median BE C0M3, 25 male). Overall, 18 patients underwent ER prior to ablation. Median percentage BE ablated was 100 % (IQR 94 %–100 %). Median visual BE surface regression at 3-month follow-up was 80 % (IQR 68 %–95 %). Multiple residual Barrett’s islands were commonly seen. Six patients (20 %) had a treatment-related complication requiring intervention, including one perforation (3 %), one postprocedural hemorrhage (3 %), and four strictures (13 %). Post-procedural pain was reported in 18 patients (60 %). Conclusions Endoscopic ablation of BE using this novel nonthermal device was found to be technically demanding, with a longer procedure time compared with established ablation techniques and a high complication rate. Based on these results, we do not recommend its use as a first-line ablation technique for the eradication of BE.

Background In 2018, the European Society of Gastrointestinal Endoscopy (ESGE) and United European Gastroenterology (UEG) published quality performance measures for endoscopic retrograde cholangiopancreatography (ERCP). Since January 2016, all endoscopists in the Netherlands have been required to register all ERCP procedures in a nationwide quality registry. This study aimed to evaluate the procedural success rates of ERCP after the implementation of mandatory national registration and to compare these with the ESGE quality performance measures. Methods This study was conducted with data from a multicenter endoscopy database. Data from 2019 and 2020 were analyzed. The primary outcome was ERCP procedural outcome. ESGE performance measures that could be evaluated were the percentage of successful bile duct cannulations in patients with virgin papillary anatomy; successful stent placement for a biliary obstruction located below the liver hilum; and complete removal of bile duct stones ( Result In total, 5295 ERCPs performed in 11 centers were included for analysis. The overall procedural success rate was 89.1 %. Successful biliary cannulation in patients with a virgin papilla was 90.3 % in nonacademic and 92.4 % in academic centers. The rates of successful stent placement in patients with a biliary obstruction located below the liver hilum were 97.0 % in nonacademic and 98.2 % in academic centers, and of successful bile duct stone extraction were 97.9 % in both nonacademic and academic centers. Conclusions The quality of ERCPs performed met five of the six evaluated ESGE performance measures. The 95 % target for successful biliary cannulation in patients with virgin papillary anatomy in academic centers was not met. Mandatory registration provides valuable insight into ERCP performance rates.

Main recommendations Malignant disease 1 ESGE recommends placement of partially or fully covered self-expandable metal stents (SEMSs) for palliation of malignant dysphagia over laser therapy, photodynamic therapy, and esophageal bypass.Strong recommendation, high quality evidence. 2 ESGE recommends brachytherapy as a valid alternative, alone or in addition to stenting, in esophageal cancer patients with malignant dysphagia and expected longer life expectancy.Strong recommendation, high quality evidence. 3 ESGE recommends esophageal SEMS placement for sealing malignant tracheoesophageal or bronchoesophageal fistulas. Strong recommendation, low quality evidence. 4 ESGE does not recommend SEMS placement as a bridge to surgery or before preoperative chemoradiotherapy because it is associated with a high incidence of adverse events. Other options such as feeding tube placement are preferable. Strong recommendation, low quality evidence. Benign disease 5 ESGE recommends against the use of SEMSs as first-line therapy for the management of benign esophageal strictures because of the potential for adverse events, the availability of alternative therapies, and their cost. Strong recommendation, low quality evidence. 6 ESGE suggests consideration of temporary placement of self-expandable stents for refractory benign esophageal strictures. Weak recommendation, moderate quality evidence. 7 ESGE suggests that fully covered SEMSs be preferred over partially covered SEMSs for the treatment of refractory benign esophageal strictures because of their very low risk of embedment and ease of removability. Weak recommendation, low quality evidence. 8 ESGE recommends the stent-in-stent technique to remove partially covered SEMSs that are embedded in the esophageal wall. Strong recommendation, low quality evidence. 9 ESGE recommends that temporary stent placement can be considered for the treatment of leaks, fistulas, and perforations. No specific type of stent can be recommended, and the duration of stenting should be individualized. Strong recommendation, low quality of evidence. 10 ESGE recommends considering placement of a fully covered large-diameter SEMS for the treatment of esophageal variceal bleeding refractory to medical, endoscopic, and/or radiological therapy, or as initial therapy for patients with massive bleeding. Strong recommendation, moderate quality evidence.

Background Stenosis of the pancreaticojejunostomy is a well-known long-term complication of pancreaticoduodenectomy. Traditionally, the endoscopic approach consisted of endoscopic retrograde pancreatography (ERP). Endoscopic ultrasound (EUS)-guided intervention has emerged as an alternative, but the success rate and adverse event rate of both treatment modalities are poorly known. We aimed to compare the outcome data of both interventions. Methods We performed a systematic literature search using the Pubmed/Medline and Embase databases in order to summarize the available data regarding efficacy and complications of ERP- and EUS-guided pancreatic duct (PD) drainage and compare these outcome data using uniform outcome measures in a multilevel logistic model. Results 13 studies were included, involving 77 patients who underwent ERP-guided drainage, 145 who underwent EUS-guided drainage, and 12 patients who underwent both modalities. An EUS-guided approach was significantly superior to an ERP-guided approach with regard to pancreatic duct opacification (87 % vs. 30 %; P Conclusion Based on limited available data, EUS-guided PD intervention appears superior to ERP-guided PD intervention.

Summary of statementsIn Europe at present, but also in 2040, 1 in 3 cancer-related deaths are expected to be caused by digestive cancers. Endoscopic technologies enable diagnosis, with relatively low invasiveness, of precancerous conditions and early cancers, thereby improving patient survival. Overall, endoscopy capacity must be adjusted to facilitate both effective screening programs and rigorous control of the quality assurance and surveillance systems required. 1 For average-risk populations, ESGE recommends the implementation of organized population-based screening programs for colorectal cancer, based on fecal immunochemical testing (FIT), targeting individuals, irrespective of gender, aged between 50 and 75 years. Depending on local factors, namely the adherence of the target population and availability of endoscopy services, primary screening by colonoscopy or sigmoidoscopy may also be recommendable. 2 In high-risk populations, endoscopic screening for gastric cancer should be considered for individuals aged more than 40 years. Its use in countries/regions with intermediate risk may be considered on the basis of local settings and availability of endoscopic resources. 3 For esophageal and pancreatic cancer, endoscopic screening may be considered only in high-risk individuals:– For squamous cell carcinoma, in those with a personal history of head/neck cancer, achalasia, or previous caustic injury; – For Barrett’s esophagus (BE)-associated adenocarcinoma, in those with long-standing gastroesophageal reflux disease symptoms (i. e., > 5 years) and multiple risk factors (age ≥ 50 years, white race, male sex, obesity, first-degree relative with BE or esophageal adenocarcinoma [EAC]). – For pancreatic cancer screening, endoscopic ultrasound may be used in selected high-risk patients such as those with a strong family history and/or genetic susceptibility.

Background Post-esophagectomy anastomotic strictures are difficult to treat. The impact of adding local steroid injection to endoscopic dilation for the treatment of post-esophagectomy anastomotic strictures is unclear. We conducted a systematic review and meta-analysis to assess the efficacy of performing steroid injection in addition to dilation. Methods A search was conducted in MEDLINE, Cochrane Library, EMBASE, and Web of Science from inception to January 2019. Randomized controlled trials (RCTs) comparing the efficacy of endoscopic dilation plus either local steroid injection (steroid group) or saline injection (placebo group) were included in the analysis. Results Three RCTs were eligible for the final analysis: 72 patients (mean age 61.3 years, 74 % male) in the steroid group and 72 patients (mean age 59.6 years, 71 % male) in the placebo group. The mean number of dilations required to resolve the stricture was significantly lower in the steroid group compared with the placebo group, with a mean weighted difference of –1.62 (95 % confidence interval [CI] –2.73 to –0.50; P = 0.004). After 6 months of follow-up, there was a trend toward more patients in the steroid group remaining dysphagia free compared with the placebo group, with a pooled odds ratio of 2.36 (95 %CI 0.94 to 5.91; P = 0.07, I2 = 24 %). Conclusion This meta-analysis showed that the addition of local steroid injection at the time of dilation for benign anastomotic strictures led to a significant decrease in the number of procedures required to resolve the stricture and may well reduce dysphagia symptoms during follow-up.

Background Digital single-operator pancreatoscopy (DSOP)-guided lithotripsy is a novel treatment modality for pancreatic endotherapy, with demonstrated technical success in retrospective series of between 88 % and 100 %. The aim of this prospective multicenter trial was to systematically evaluate DSOP in patients with chronic pancreatitis and symptomatic pancreatic duct stones. Methods Patients with symptomatic chronic pancreatitis and three or fewer stones ≥ 5mm in the main pancreatic duct (MPD) of the pancreatic head or body were included. The primary end point was complete stone clearance (CSC) in three or fewer treatment sessions with DSOP. Current guidelines recommend extracorporeal shock wave lithotripsy (ESWL) for MPD stones > 5 mm. A performance goal was developed to show that the CSC rate of MPD stones using DSOP was above what has been previously reported for ESWL. Secondary end points were pain relief measured with the Izbicki pain score (IPS), number of interventions, and serious adverse events (SAEs). Results 40 chronic pancreatitis patients were included. CSC was achieved in 90 % of patients (36/40) on intention-to-treat analysis, after a mean (SD) of 1.36 (0.64) interventions (53 procedures in total). The mean (SD) baseline IPS decreased from 55.3 (46.2) to 10.9 (18.3). Overall pain relief was achieved in 82.4 % (28/34) after 6 months of follow-up, with complete pain relief in 61.8 % (21/34) and partial pain relief in 20.6 % (7/34). SAEs occurred in 12.5 % of patients (5/40), with all treated conservatively. Conclusion DSOP-guided endotherapy is effective and safe for the treatment of symptomatic MPD stones in highly selected patients with chronic pancreatitis. It significantly reduces pain and could be considered as an alternative to standard ERCP techniques for MPD stone treatment in these patients.

In this concluding chapter, I recapitulate key points of interest raised in the preceding chapters. In particular, I reiterate how unequal power relations ultimately affected language learning possibilities among marginalized individuals and emphasize the need to reconceptualize language learning through an ideology and identity lens. Such an understanding, I point out, focuses on how learners engage in acts of discursive positioning in relation to language ideologies and circulating ideologies around them. Following this overview of the book, I discuss implications of this study for second language acquisition (SLA) scholarship and emphasize how the findings are relevant to educators, researchers, and policy makers. Directions for future SLA research are also discussed in order to expand our understanding of the dynamics of language learning.

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Contains fulltext : 220063.pdf (Publisher’s version ) (Closed access) We are currently living in the throes of the COVID-19 pandemic that imposes a significant stress on health care providers and facilities. Europe is severely affected with an exponential increase in incident infections and deaths. The clinical manifestations of COVID-19 can be subtle, encompassing a broad spectrum from asymptomatic mild disease to severe respiratory illness. Health care professionals in endoscopy units are at increased risk of infection from COVID-19. Infection prevention and control has been shown to be dramatically effective in assuring the safety of both health care professionals and patients. The European Society of Gastrointestinal Endoscopy (www.esge.com) and the European Society of Gastroenterology and Endoscopy Nurses and Associates (www.esgena.org) are joining forces to provide guidance during this pandemic to help assure the highest level of endoscopy care and protection against COVID-19 for both patients and endoscopy unit personnel. This guidance is based upon the best available evidence regarding assessment of risk during the current status of the pandemic and a consensus on which procedures to perform and the priorities on resumption. We appreciate the gaps in knowledge and evidence, especially on the proper strategy(ies) for the resumption of normal endoscopy practice during the upcoming phases and end of the pandemic and therefore a list of potential research questions is presented. New evidence may result in an updated statement.

Main RecommendationsESGE recommends against routine preoperative biliary drainage in patients with malignant extrahepatic biliary obstruction; preoperative biliary drainage should be reserved for patients with cholangitis, severe symptomatic jaundice (e. g., intense pruritus), or delayed surgery, or for before neoadjuvant chemotherapy in jaundiced patients. Strong recommendation, moderate quality evidence. ESGE recommends the endoscopic placement of a 10-mm diameter self-expandable metal stent (SEMS) for preoperative biliary drainage of malignant extrahepatic biliary obstruction. Strong recommendation, moderate quality evidence.ESGE recommends SEMS insertion for palliative drainage of of extrahepatic malignant biliary obstruction. Strong recommendation, high quality evidence. ESGE recommends against the insertion of uncovered SEMS for the drainage of extrahepatic biliary obstruction of unconfirmed etiology. Strong recommendation, low quality evidence. ESGE suggests against routine preoperative biliary drainage in patients with malignant hilar obstruction. Weak recommendation, low quality evidence.ESGE recommends uncovered SEMSs for palliative drainage of malignant hilar obstruction. Strong recommendation, moderate quality evidence.ESGE recommends temporary insertion of multiple plastic stents or of a fully covered SEMS for treatment of benign biliary strictures. Strong recommendation, moderate quality evidence.ESGE recommends endoscopic placement of plastic stent(s) to treat bile duct leaks that are not due to transection of the common bile duct or common hepatic duct. Strong recommendation, moderate quality evidence.

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Background COVID-19 has dramatically affected gastrointestinal endoscopy practice. We aimed to investigate its impact on procedure types, indications, and findings. Methods We retrospectively analyzed endoscopies performed in 15 Dutch hospitals by comparing periods 15 March to 25 June of 2019 and 2020 using the prospective Trans.IT database. Results During lockdown in 2020, 9776 patients underwent endoscopy compared with 19 296 in 2019. Gastroscopies decreased by 57 % (from 7846 to 4467) and colonoscopies by 45 % (from 12219 to 5609), whereas endoscopic retrograde cholangiopancreatography volumes remained comparable (from 578 to 522). Although endoscopy results indicative of cancer decreased (from 524 to 340), the likelihood of detecting cancer during endoscopy increased (2.7 % [95 % confidence interval (CI) 2.5 – 3.0] in 2019 versus 3.5 % [95 %CI 3.1 – 3.9] in 2020; P

Item does not contain fulltext This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE), endorsed by the European Society for Radiotherapy and Oncology (ESTRO), the European Society of Digestive Endoscopy (ESDO), and the European Society for Clinical Nutrition and Metabolism (ESPEN). The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system was adopted to define the strength of recommendations and the quality of evidence. Main recommendations for malignant disease 1 ESGE recommends placement of partially or fully covered self-expandable metal stents (SEMSs) for palliative treatment of malignant dysphagia over laser therapy, photodynamic therapy, and esophageal bypass (strong recommendation, high quality evidence). 2 For patients with longer life expectancy, ESGE recommends brachytherapy as a valid alternative or in addition to stenting in esophageal cancer patients with malignant dysphagia. Brachytherapy may provide a survival advantage and possibly a better quality of life compared to SEMS placement alone. (Strong recommendation, high quality evidence.) 3 ESGE recommends esophageal SEMS placement as the preferred treatment for sealing malignant tracheoesophageal or bronchoesophageal fistula (strong recommendation, low quality evidence). 4 ESGE does not recommend the use of concurrent external radiotherapy and esophageal stent treatment. SEMS placement is also not recommended as a bridge to surgery or prior to preoperative chemoradiotherapy. It is associated with a high incidence of adverse events and alternative satisfactory options such as placement of a feeding tube are available. (Strong recommendation, low quality evidence.) Main recommendations for benign disease 1 ESGE recommends against the use of self-expandable stents (SEMSs) as first-line therapy for the management of benign esophageal strictures because of the potential for adverse events, the availability of alternative therapies, and costs (strong recommendation, low quality evidence). 2 ESGE suggests consideration of temporary placement of SEMSs as therapy for refractory benign esophageal strictures (weak recommendation, moderate evidence). Stents should usually be removed at a maximum of 3 months (strong recommendation, weak quality evidence). 3 ESGE suggests that fully covered SEMSs be preferred over partially covered SEMSs for the treatment of refractory benign esophageal strictures, because of their lack of embedment and ease of removability (weak recommendation, low quality evidence). 4 For the removal of partially covered esophageal SEMSs that are embedded, ESGE recommends the stent-in-stent technique (strong recommendation, low quality evidence). 5 ESGE recommends that temporary stent placement can be considered for treating esophageal leaks, fistulas, and perforations. The optimal stenting duration remains unclear and should be individualized. (Strong recommendation, low quality evidence.) 6 ESGE recommends placement of a SEMS for the treatment of esophageal variceal bleeding refractory to medical, endoscopic, and/or radiological therapy, or as initial therapy for patients with massive esophageal variceal bleeding (strong recommendation, moderate quality evidence).

Background The importance of high quality preprocedural bowel preparation is widely acknowledged, but suboptimal bowel cleansing still occurs in up to 20 % of all colonoscopy patients. The aim of this study was to evaluate the performance of a novel intraprocedural cleaning device for cleaning poorly prepared colons. Methods This multicenter feasibility study included patients aged 18 – 75 years who were referred for colonoscopy. Intraprocedural cleaning was performed in patients after a limited preprocedural bowel preparation regimen (2 days of dietary restrictions and 2 × 10 mg bisacodyl). The primary outcome was the proportion of adequately prepared patients (Boston Bowel Preparation scale [BBPS] ≥ 2 in each segment) before and after segmental washing with the new device. Secondary outcomes included: cecal intubation rate, procedure time, system usability, patient satisfaction, and safety. Results 47 patients (42.6 % male), with a median age of 61 years (interquartile range [IQR] 46 – 67 years), were included at three clinical sites. Cecal intubation was achieved in 46/47 patients (97.9 %). The cleaning device significantly improved the proportion of patients with adequate bowel cleansing (from 19.1 % to 97.9 %; P Conclusions This feasibility study suggests that the intraprocedural cleaning device appears to be safe and effective in cleaning poorly prepared colons to an adequate level, allowing a thorough colorectal examination.

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Item does not contain fulltext The 22nd United European Gastroenterology (EUG) Week took place in Vienna in October 2014. The meeting offered a great opportunity to all those interested in gastrointestinal (GI) endoscopy to exchange clinical experiences, research trends, and scientific progress from all over the world. This report will highlight some of the most interesting topics of GI endoscopy that were presented over the 3 days, and will briefly comment on them in light of the latest bibliographic data.

Endoscopic retrograde cholangiopancreatography (ERCP) in patients with a preexisting duodenal stent covering the papilla is particularly challenging. The aim of this study was to describe a multicenter experience of performing ERCP in patients with biliary obstruction in whom the papilla was obscured by a preexisting duodenal stent. A total of 38 patients with preexisting duodenal stents obscuring the papilla underwent ERCP. Endoscopic biliary cannulation was successful in 13 patients (34.2 %). In 12 of these 13 patients (92.3 %), endoscopic therapy was performed during the same procedure and achieved clinical success with relief of jaundice in all cases (100 %). The most commonly utilized procedure in patients in whom ERCP failed was EUS-guided biliary drainage (EGBD; n = 13 /22, 59.1 %), followed by percutaneous transhepatic biliary drainage (n = 9 /22, 40.9 %). Three patients in whom ERCP failed either did not consent to further intervention or were transferred to other centers. Thus, ERCP was technically challenging in our cohort of patients with preexisting duodenal stents, but was nonetheless successful in about one third of cases. Overall, when performed by experts, endoscopic biliary drainage (via ERCP or EGBD) can be successfully achieved in the majority of patients with indwelling duodenal stents.

Item does not contain fulltext Background and aims In multiple endocrine neoplasia type 1 (MEN1), endoscopic ultrasound (EUS) is used for identification and follow-up of pancreatic neuroendocrine tumors (PNETs). The role of EUS in surveillance of small ( < 20 mm) PNETs is unclear, mostly because the natural course of these lesions is largely unknown. We aimed to determine annual growth and incidence rate of small PNETs in patients with MEN1 using EUS-based surveillance. Patients and methods Linear array EUS procedures in patients with MEN1 between 2002 and 2015 were identified. Number, size, and location of PNETs were recorded. Annual growth of PNETs < 20 mm identified at the initial EUS ("prevalent" PNETs) and during follow-up ("incident" PNETs) was calculated using mixed model linear regression analysis. Results A total of 54 patients were identified and 38 patients were included. In all, 226 PNETs were identified (median size 5.0 mm, interquartile range 3.7 - 7.5) of which 124 (55 %) were prevalent and 102 (45 %) were incident PNETs. Annual incidence rate was 0.79 PNETs/year (95 % confidence interval [CI] 0.73 to 0.87). Overall growth rate was 0.10 mm/year (95 %CI 0.02 to 0.19; P = 0.01); PNETs < 10 mm (n = 198) did not grow (P = 0.23), whereas PNETs >/= 10 mm (n = 28) grew 0.44 mm/year (95 %CI 0.10 to 0.78; P = 0.01). Prevalent PNETs grew 0.21 mm/year (95 %CI 0.10 - 0.32; P < 0.001), whereas incident PNETs did not grow (P = 0.26). Conclusions The annual growth rate of small, solid PNETs in patients with MEN1 is lower than previously thought. Surveillance intervals could probably be prolonged without compromising safety.

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Background Dilation is the standard of care for recurrent benign esophageal strictures (BES). Biodegradable stents may prolong the effect of dilation and reduce recurrences. Efficacy and safety of dilation and biodegradable stent placement early in the treatment algorithm of recurrent BES were compared. Methods This multicenter, randomized study enrolled patients with BES treated with previous dilations to ≥ 16 mm. The primary end point was number of repeat endoscopic dilations for recurrent stricture within 3 and 6 months. Secondary outcomes through 12 months included safety, time to first dilation for recurrent stricture, dysphagia, and level of activity. Results At 3 months, the biodegradable stent group (n = 32) underwent significantly fewer endoscopic dilations for recurrent stricture compared with the dilation group (n = 34; P Conclusion Biodegradable stent placement is associated with temporary reduction in number of repeat dilations and prolonged time to recurrent dysphagia compared with dilation. Additional studies are needed to better define the exact role of biodegradable stent placement to treat recurrent BES.

Background and study aims: Technological innovation in esophageal stent design has progressed over the past decades, but the association between the mechanical properties of stent design and clinical outcome is still poorly understood. In this study the radial force and axial force of currently available stent designs were evaluated using an in vitro testing model. Methods: A total of 10 partially and fully covered self-expanding metal stents (SEMSs), a self-expanding plastic stent (SEPS), and an uncovered biodegradable stent were evaluated. Radial force and axial force were measured using a radial force measurement machine (RX500) and a force gauge in an oven at 37°C. Results: A wide range of radial force measurements were observed between the different stent designs, ranging from 4 to 83 N at 15 mm expansion. All braided nitinol stents displayed comparable mechanical characteristics with a relatively low radial force ( 300 N) followed by a steep decline to 0 N during expansion. Conversely, peak axial force was relatively high for braided nitinol SEMSs (> 1.5 N), whereas nonbraided SEMSs showed a much lower peak axial force ( Conclusions: All currently available stents have a characteristic radial and axial force pattern, which may aid in the understanding of the occurrence of specific symptoms and complications after stent placement. Nonetheless, the overall clinical behavior of a stent is probably more complex and cannot be explained by these factors alone.

BACKGROUND AND STUDY AIMS Enteral stent placement has emerged as a safe and effective palliative treatment option for patients with malignant gastric outlet obstruction (GOO). In an attempt to further optimize this treatment new enteral stents have been designed. This study is the first to describe the results regarding technical success, clinical success, complication rate, and stent dysfunction of the Evolution duodenal stent (Cook Medical, Limerick, Ireland). PATIENTS AND METHODS A total of 46 patients with symptomatic malignant GOO were included in this prospective multicenter cohort study. All patients who successfully received an Evolution duodenal stent were followed until death. RESULTS The technical and clinical success rates were 89 % (95 % confidence interval [CI] 77 % - 95 %) and 72 % (95 %CI 58 % - 83 %), respectively. The GOO Scoring System score, the Global Health Score, and the EuroQol visual analog scale improved significantly (GOOSS and Global Health Score P < 0.0001; EuroQol P = 0.005) when scores before stenting were compared with scores after stent placement. Median survival was 87 days, and stent patency was observed in 67 % for up to 395 days, accounting for death unrelated to the stent as a competing risk. Stent dysfunction occurred in 14 patients (30 %) (stent ingrowth n = 9; stent migration n = 2; extrinsic compression on the stent n = 2; food impaction n = 1). CONCLUSION These first data on the new Evolution duodenal stent show that it is safe and effective for the palliative treatment of symptomatic malignant GOO.

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BACKGROUND AND STUDY AIMS: Gastric outlet obstruction (GOO) is a late complication of advanced gastric, periampullary, and duodenal malignancies. Palliation of obstruction is the primary aim of treatment in these patients. Self-expandable metal stents have emerged as a promising treatment option. Our aim was to investigate the safety and efficacy of a new non-foreshortening nitinol duodenal stent. PATIENTS AND METHODS: A total of 52 patients with symptomatic malignant GOO were studied in this prospective multicenter cohort study. All patients received a D-Weave Niti-S duodenal stent (Taewoong Medical, Seoul, South Korea). Patients were followed up until withdrawal of informed consent or death. RESULTS: The cause of GOO was pancreatic cancer in the majority of patients (62 %). The technical and clinical success rates were 96 % and 77 %, respectively. The GOO Scoring System score improved significantly ( P < 0.0001) when the scores before stenting were compared with the mean scores until death. Median survival was 82 days and stent patency was observed in 75 % for up to 190 days, accounting for death as a competing risk. In 13 patients (25 %) stent dysfunction occurred (tumor ingrowth in 11, stent migration in two). Over time, the body mass index, the World Health Organization performance score, and the EuroQol visual analog scale revealed a not significant change ( P = 0.52, P = 0.43, and P = 0.15, respectively), whereas the global health status improved significantly ( P = 0.001). CONCLUSION: Placement of a new non-foreshortening nitinol enteral stent is safe and without major complications. This stent design produces significant relief of obstructive symptoms and improves quality of life in patients with incurable malignant GOO.

Background and study aims In patients with presumed Barrett esophagus we evaluated clinical risk factors that could predict the presence of intestinal metaplasia and dysplasia in biopsies of columnar-lined esophagus (CLE), independently of histological results. Patients and methods In 908 patients with CLE of length > or = 2 cm, data on age, sex, reflux symptoms, tobacco and alcohol use, medication use, and upper gastrointestinal endoscopy findings were prospectively collected. Multivariate logistic regression analysis was performed, and a model for predicting the histological results was developed. Results In 127/908 patients, biopsies of CLE did not contain intestinal metaplasia. Of the 781 patients with intestinal metaplasia, 663 patients (85%) had no dysplasia, and 118 (15%) had low grade dysplasia (LGD). The most important predictors for the presence of intestinal metaplasia were length of CLE, size of hiatal hernia, and male sex, while among those with intestinal metaplasia, age and male sex were most important for the presence of LGD. Multivariate combinations of these predictors yielded reliable models, which were able to discriminate intestinal metaplasia well from no intestinal metaplasia (area under receiver operating characteristic [ROC] curve 0.82), but only reasonably discriminated LGD from no dysplasia (area under ROC 0.65). Conclusions A simple model based on clinical findings can be used to predict the presence of intestinal metaplasia in biopsies from CLE. In contrast, predicting the presence of LGD versus no dysplasia in intestinal metaplasia is more difficult. Predictions from these models may aid decision making on whether a patient with CLE should have surveillance, in view of the known sampling error at endoscopy and interobserver variability at histology.

Background and study aim: An overestimation of the accuracy of endoscopic ultrasound (EUS) results in rectal cancer staging has been reported recently, which was found to be caused by the selective reporting of more positive results. In this study, we assessed whether publication bias was also present in the reporting of EUS staging results in upper gastrointestinal cancer. Methods: A Medline literature search was performed. English-language articles containing information on the accuracy of EUS for T staging and/ or N staging of esophageal, gastric, and pancreatic cancer were included. Articles published in abstract form only, case reports, and reviews were excluded. Studies reporting EUS results of patients who had undergone preoperative radiation and/or chemotherapy were also excluded. EUS results were plotted against numbers of patients, year of publication, journal type, and journal impact factor. Results: The plots of the numbers of patients against accuracies for T stage and N stage and the statistical analyses showed no evidence of publication bias with regard to upper gastrointestinal cancer. The reported accuracy of EUS for the T stage of esophageal, gastric, and pancreatic cancer declined slightly over the years, but this was statistically significant only in the case of esophageal cancer (P = 0.01). No statistically significant correlations were found for N staging for any of the three types of cancer. In addition, no correlations were found between EUS results and journal type or journal impact factor. Conclusion: No evidence was found for the selective reporting of more positive EUS results for esophageal, gastric, and pancreatic cancer staging, which suggests that publication bias was not present.

__Background and study aims:__ Patients with Barrett's esophagus are recommended to undergo regular surveillance with upper gastrointestinal endoscopy, an invasive procedure that may cause anxiety, pain, and discomfort. We assessed to what extent patients perceived this procedure as burdensome. __Patients and methods:__ A total of 192 patients with Barrett's esophagus were asked to fill out questionnaires at 1 week and immediately before endoscopy, and at 1 week and 1 month afterwards. Four variables were assessed: (i) pain and discomfort experienced during endoscopy; (ii) symptoms; (iii) psychological burden, i. e., anxiety, depression and distress levels (Hospital Anxiety and Depression scale, Impact of Event Scale); and (iv) perceived risk of developing adenocarcinoma. __Results:__ At least one questionnaire was returned by 180 patients (94%),151 completed all four (79%). Of all patients, only 14% experienced the endoscopy as painful. However, 59% reported it to be burdensome. Apart from an increase in throat ache (47% after endoscopy versus 12% before), the procedure did not cause physical symptoms. Patients' anxiety, depression, and distress levels were significantly increased in the week before endoscopy compared with the week after. Patients perceiving their risk of developing adenocarcinoma as high reported higher levels of psychological distress and that the procedure was a greater burden. __Conclusions:__ Upper gastrointestinal endoscopy is burdensome for many patients with Barrett's esophagus and causes moderate distress. Perception of a high risk of adenocarcinoma may increase distress and the burden experienced from the procedure. The benefits of endoscopic surveillance for patients with Barrett's esophagus should be weighed against its drawbacks, including the short-term burden for patients.

BACKGROUND AND STUDY AIMS: Recurrent dysphagia frequently complicates the palliative treatment of esophageal cancer with self-expanding metal stents. Strategies for repeat interventions and subsequent outcomes have not been adequately reported to date. PATIENTS AND METHODS: A total of 216 patients underwent placement of a self-expanding metal stent (Ultraflex, n = 75; Flamingo Wallstent, n = 71; Z-stent, n = 70) for malignant dysphagia, and were followed up prospectively. The causes of stent-related recurrent dysphagia, the intervals after first stent placement, and the procedures used for repeat intervention and their outcomes were evaluated. RESULTS: Seventy-four episodes of stent-related recurrent dysphagia occurred in 63 patients (29 %), mainly due to tumor overgrowth (n = 30; median 129 days), stent migration (n = 26; median 92 days) and food bolus obstruction (n = 16; median 80 days). Stent migration occurred more frequently ( P = 0.05), whereas tumor overgrowth occurred less frequently ( P = 0.05) with Ultraflex stents in comparison with Flamingo Wallstents and Z-stents. Tumor overgrowth was treated in 25 patients mainly by a second stent (n = 19) and was effective in 23 of the 25 patients (92 %). Five patients received no further treatment. Stent migration was treated by placing a second stent (n = 14), repositioning the migrated stent (n = 7), other treatments (n = 3), or no further treatment (n = 2), and treatment was effective in 20 of 24 (83 %) patients. Food bolus obstruction was treated by endoscopic stent clearance in all patients. Repeat intervention for stent-related recurrent dysphagia improved the dysphagia score from a median of 3 to 1 ( P < 0.001). The median survival period after repeat treatment was 68 days. CONCLUSIONS: Recurrent dysphagia occurs in almost one-third of patients after stent placement. Repeat interventions for stent-related recurrent dysphagia are effective in over 90 % of patients. New innovations in stent design are needed to reduce the risk of stent-related recurrent dysphagia.

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The aim of the Expert Approach section is to contribute to the dissemination and standardization of new endoscopic procedures. Authors from three distinct geographic areas combine forces, sharing their experience to form a consensus of opinion. Readers' comments are welcome and will be published in the Mailbox which appears at the end of each Expert Approach article.

Background and study aims: A new esophageal stent with two anti-migration features was developed to minimize migration. The aim of this study was to evaluate the clinical efficacy and safety of this stent in patients with malignant dysphagia. Patients and methods: A total of 40 patients with dysphagia due to a malignant obstruction of the esophagus were prospectively enrolled in this cohort study. Results: Stent placement was technically successful in 39 patients (98 %). The median dysphagia-free time after stent placement was 220 days (95 % confidence interval 94 – 345 days). Nine patients (23 %) experienced recurrent dysphagia due to tissue overgrowth (n = 2), stent fracture (n = 1), and partial (n = 5) or complete (n = 1) stent migration. A total of 16 serious adverse events occurred in 14 patients (36 %), with hemorrhage (n = 3) and severe nausea or vomiting (n = 3) being the most common causes. Conclusions: This new stent design was effective for the palliation of malignant dysphagia and had a low rate of recurrent dysphagia. However, despite the anti-migration features, stent migration was still a major cause of recurrent dysphagia. Furthermore, treatment was associated with a high adverse event rate. Dutch Trial Registration (NTR 3313)

Endoscopic placement of self-expandable metal stents (SEMS) has emerged as a palliative treatment for patients with malignant gastric outlet obstruction (GOO). Recently, a new partially covered “big cup” SEMS has been developed to prevent both stent migration and tissue ingrowth. The aim of the study was to evaluate safety and efficacy of this SEMS in a cohort of patients with incurable malignant GOO. The study was terminated prematurely due to three proximal stent migrations in six patients. Migrations occurred at 2, 4, and 29 days, respectively, and necessitated endoscopic removal and placement of another SEMS. The remaining three patients had a patent SEMS at the end of follow-up. The high proximal migration rate of this new SEMS should be taken into account when considering routine clinical use in malignant GOO. Further research is warranted in order to find an optimal stent design that prevents both stent migration and tumor ingrowth.

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