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Background Optical diagnosis of colonic polyps is poorly reproducible outside of high volume referral centers. The present study aimed to assess whether real-time artificial intelligence (AI)-assisted optical diagnosis is accurate enough to implement the leave-in-situ strategy for diminutive (≤ 5 mm) rectosigmoid polyps (DRSPs). Methods Consecutive colonoscopy outpatients with ≥ 1 DRSP were included. DRSPs were categorized as adenomas or nonadenomas by the endoscopists, who had differing expertise in optical diagnosis, with the assistance of a real-time AI system (CAD-EYE). The primary end point was ≥ 90 % negative predictive value (NPV) for adenomatous histology in high confidence AI-assisted optical diagnosis of DRSPs (Preservation and Incorporation of Valuable endoscopic Innovations [PIVI-1] threshold), with histopathology as the reference standard. The agreement between optical- and histology-based post-polypectomy surveillance intervals (≥ 90 %; PIVI-2 threshold) was also calculated according to European Society of Gastrointestinal Endoscopy (ESGE) and United States Multi-Society Task Force (USMSTF) guidelines. Results Overall 596 DRSPs were retrieved for histology in 389 patients; an AI-assisted high confidence optical diagnosis was made in 92.3 %. The NPV of AI-assisted optical diagnosis for DRSPs (PIVI-1) was 91.0 % (95 %CI 87.1 %–93.9 %). The PIVI-2 threshold was met with 97.4 % (95 %CI 95.7 %–98.9 %) and 92.6 % (95 %CI 90.0 %–95.2 %) of patients according to ESGE and USMSTF, respectively. AI-assisted optical diagnosis accuracy was significantly lower for nonexperts (82.3 %, 95 %CI 76.4 %–87.3 %) than for experts (91.9 %, 95 %CI 88.5 %–94.5 %); however, nonexperts quickly approached the performance levels of experts over time. Conclusion AI-assisted optical diagnosis matches the required PIVI thresholds. This does not however offset the need for endoscopistsʼ high level confidence and expertise. The AI system seems to be useful, especially for nonexperts.

Background: Patients on immunosuppressive drugs have been excluded from COVID-19 vaccines trials, creating concerns regarding their efficacy. Aims: To explore the humoral response to COVID-19 vaccines in patients with inflammatory bowel disease (IBD) Methods: Effectiveness and Safety of COVID-19 Vaccine in Patients with Inflammatory Bowel Disease (IBD) Treated with Immunomodulatory or Biological Drugs (ESCAPE-IBD) is a prospective, multicentre study promoted by the Italian Group for the study of Inflammatory Bowel Disease. We present data on serological response eight weeks after the second dose of COVID-19 vaccination in IBD patients and healthy controls (HCs). Results: 1076 patients with IBD and 1126 HCs were analyzed. Seropositivity for anti-SARS-CoV-2 IgG was reported for most IBD patients, even if with a lesser rate compared with HCs (92.1% vs. 97.9%; p

Esophagogastroduodenoscopy (EGD) plays a crucial role in the management of gastroduodenal diseases by allowing a direct and accurate evaluation of the mucosa and the execution of several operative maneuvers. Despite a constant development of new imaging tools and operative devices, the widespread use of EGD has not resulted in a significant reduction of mortality for patients affected by esophageal/gastric cancer during the last three decades in Western countries. Evidence indicates that this disheartening scenario derives from a high variability of execution of EGD which determines its quality and diagnostic yield, delaying the diagnosis of neoplastic diseases. Based on this evidence, in recent years many scientific societies have produced different position papers aimed at defining quality performance measures in EGD. Thus, the Italian Association of Gastroenterologists and Endoscopists, the Italian Society of Digestive Endoscopy and the Italian Society of Gastroenterology have produced this joint document based on the review of ASGE, ACG, BSG, ESGE and Asian Consensus EGD position papers with the aim of indicating the quality standards of EGD (pre-, intra- and post-procedure) focused on lesion detection to be adopted in the Italian context.

Background Endoscopic ultrasound (EUS)-guided biliary drainage is becoming an option for palliation of malignant biliary obstruction. Lumen-apposing metal stents (LAMS) are replacing self-expandable metal stents (SEMS). The aim of this meta-analysis was to evaluate the efficacy and safety of LAMS and SEMS for EUS-guided choledochoduodenostomy (EUS-CDS). Methods A meta-analysis was performed using PRISMA protocols. Electronic databases were searched for studies on EUS-CDS. The primary outcome was clinical success. Secondary outcomes were technical success, reintervention, and adverse events. We used the random effects model with the DerSimonian–Laird estimation, and the results were depicted using forest plots. Subgroup analyses were also performed with data stratified by selected variable. Results Overall, 31 studies (820 patients) were included. The pooled rates of clinical and technical success were 93.6 % (95 % confidence interval [CI] 88.6 %–96.5 %) and 94.8 % (95 %CI 90.2 %–97.3 %) for LAMS, and 91.7 % (95 %CI 88.1 %–94.2 %) and 92.7 % (95 %CI 89.9 %–94.9 %) for SEMS, respectively. The pooled rates of adverse events were 17.1 % (95 %CI 12.5 %–22.8 %) for LAMS and 18.3 % (95 %CI 14.3 %–23.0 %) for SEMS. The pooled rates of reintervention were 10.9 % (95 %CI 7.7 %–15.3 %) for LAMS and 13.9 % (95 %CI 9.6 %–19.7 %) for SEMS. Subgroup analyses confirmed these results. Conclusions This meta-analysis showed that LAMS and SEMS are comparable in terms of efficacy for EUS-CDS. Clinical and technical success, post-procedure adverse events, and reintervention rates were similar between LAMS and SEMS use; however, adverse events require further investigation.

To generate a prognostic model based on a nomogram for adverse event (AE) prediction after lumen-apposing metal stents (LAMS) placement in patients with pancreatic fluid collections (PFC).Data from a large multicenter series of PFCs treated with LAMS placement were retrieved. AE (overall and excluding mild events) prediction was calculated through a logistic regression model and a nomogram was created and internally validated after bootstrapping. Results were expressed in terms of odds ratio (OR) and 95% confidence interval (CI). Discrimination was assessed by c-statistics and calibrated by comparing deciles of predicted and observed ORs.Overall, 516 patients were included (males 68%, mean age 61.6 ± 15.2 years). PFCs were predominantly walled-off necrosis (52.1%). Independent predictors of AE occurrence were injury of main pancreatic duct (OR in the case of leak 2.51, 95% CI 1.06-5.97, P = 0.03; OR in the case of complete disruption 2.61, 1.53-4.45, P = 0.01), abnormal vessels (OR in the case of perigastric varices 2.90, 1.31-6.42, P = 0.008; OR in the case of pseudoaneurysm 2.99, 1.75-11.93, P = 0.002), using a multigate technique (OR 3.00, 1.28-5.24; P = 0.05), and need of percutaneous drainage (OR 2.81, 1.03-7.65, P = 0.04). By nomogram, a score beyond 200 points corresponded to a 50% probability of AE occurrence. The model was confirmed even when excluding mild AEs and it showed optimal discrimination (c-index 76.8%, 95% CI 74-79), confirmed after internal validation.Patients with preprocedural evidence of pancreatic duct leak/disruption, vessel alteration, requiring percutaneous drainage or a multigate technique are at higher risk for AE.

EUS-guided choledochoduodenostomy (EUS-CDS) with a lumen-apposing metal stent (LAMS) has been proposed as an alternative procedure in patients with distal malignant biliary obstruction (DMBO) and failed ERCP.This multicenter, retrospective analysis included all cases of EUS-CDS with LAMS performed in patients with DMBO and failed ERCP in 23 Italian centers from January 2016 to July 2020. Primary endpoints were technical and clinical success. Secondary endpoints were the assessment of the adverse event (AE) rate and variables associated with technical success.Two hundred fifty-six patients (44.9% women) with a mean age of 73.9 ± 12.6 years were included in the study. The most common etiology of DMBO was pancreatic adenocarcinoma (75%), followed by ampullary cancer (8.6%) and cholangiocarcinoma (6.6%). The common bile duct median diameter was 17.3 ± 3.9 mm. Technical and clinical success were achieved in 239 of 256 (93.3%), and 230 of 239 (96.2%) patients, respectively. The mean follow-up was 151 ± 162 days. Twenty-seven AEs occurred in 25 of 239 patients (10.5%) (3 mild, 21 moderate, and 3 severe). No fatal AEs occurred. Reinterventions to manage AEs with endoscopic or radiologic procedures occurred in 22 patients (9.2%).The results of our study show that EUS-CDS with LAMSs in patients with DMBO and failed ERCP represent a viable alternative in terms of effectiveness and safety with acceptable AE rates. (Clinical trial registration number: NCT03903523.).

There is increasing interest in expanding the use of lumen-apposing metal stents (LAMSs) in patients with pancreatic fluid collections (PFCs). The aim of this study was to determine whether there is a hospital volume threshold for which patient outcomes could be optimized.Data from a large multicenter series of patients with PFCs treated with LAMSs were retrieved. Rate of adverse events (AEs) was the primary outcome. Multivariable models with restricted cubic splines were used to identify a hospital volume threshold by plotting hospital volume against the log odds ratio (OR) of AE rate. Propensity score matching was applied to obtain 2 well-balanced groups according to hospital volume, and univariate/multivariate logistic regression analysis was performed to identify significant predictors of AEs.Overall, 516 patients were included. Increasing hospital volume was associated with a reduced AE rate (P = .03), and the likelihood of experiencing an AE declined as hospital volume increased up to 15 cases. After propensity score matching, 175 patients in the high-volume (15 cases) and 132 in the low-volume hospital group were compared. Overall, 41 AEs were observed (13.3%), of which 14 (8%) and 27 (20.4%) occurred at high-volume and low-volume centers, respectively (P = .001). Severe and fatal events were observed more frequently in low-volume centers (6% vs 1.7% and 2.2% vs 0%, respectively; P = .05). In multivariate analysis, main pancreatic duct injury (OR, 2.62; 95% confidence interval [CI], 1.26-4.67; P = .02), presence of abnormal vessels (OR, 2.93; 95% CI, 1.41-5.02; P = .006), and institutional experience (OR, 2.95; 95% CI, 1.48-5.90; P = .002) were significant predictors of AEs.With 15 procedures representing the minimum number of cases associated with the lowest risk for postprocedural AEs, hospital volume is associated with improved outcomes. (Clinical trial registration number: NCT03903523.).

Background/Aims: The coronavirus disease 2019 (COVID-19) outbreak has modified the activities of endoscopy units worldwide. Herein, we investigated the impact of the COVID-19 outbreak on anesthesiologist assistance for endoscopic procedures in Lombardy, Italy.Methods: A questionnaire concerning anesthesiologist assistance provided from October 26 to December 6, 2020, in comparison with the same period in 2019, was sent to endoscopic units in Lombardy.Results: Approximately 54% (34/63) of the units responded. A reduction in the number of all endoscopies (-33.5%; 18792 in 2020 vs. 28264 in 2019) and anesthesiologist-assisted endoscopies (-15.3%; 2652 in 2020 vs. 3132 in 2019) was reported. A greater reduction in anesthesiologist assistance was observed in government community units (-29.5%) than in academic (-14%) and private community units (-4.6%). Among all units, 85% reported a reduction in anesthesiologist assistance; 65% observed a delay/cancellation of procedures; 59%, a restricted patient selection; 17%, the need to transfer some patients to other hospitals; and 32%, a related worsening of procedure quality.Conclusion: The COVID-19 pandemic compromised the anesthesiologist assistance for endoscopic procedures in Lombardy, which worsened the procedure quality mainly in government community units. The COVID-19 “stress test” suggests a more balanced allocation of anesthesiologic resources in the future.

Background & Aim: Standard 10-day sequential therapy is advised as first-line therapy for Helicobacter pylori (H. pylori) eradication by current Italian guidelines. Some data suggested that a 14-day regimen may achieve higher eradication rates. This study compared the efficacy of sequential therapy administered for either 10- or 14-days.Methods: This prospective, multicenter, open-label study enrolled patients with H. pylori infection without previous treatment. Patients were receiving a sequential therapy for either 10 or 14 days with esomeprazole 40 mg and amoxicillin 1 g (5 or 7 days) followed by esomeprazole 40 mg, clarithromycin 500 mg and tinidazole 500 mg (5 or 7 days), all given twice daily. Bacterial eradication was checked using 13C-urea breath test. Eradication cure rates were calculated at both Intention-to-treat (ITT) and per-protocol (PP) analyses.Results: A total of 291 patients were enrolled, including 146 patients in 10-day and 145 in the 14-day regimen. The eradication rates were 87% (95% CI = 81.5-92.4) and 90.3% (95% CI = 85.5-95.1) at ITT analysis with the 10- and 14-day regimen, respectively, and 92.7% (95% CI = 88.3-97) and 97% (95% CI = 94.2-99.9) at PP analysis (p =0.37). Among patients, who earlier had interrupted therapy, bacterial eradication was achieved in 8 out of 9 who completed the first therapy phase and performed at least ≥3 days of triple therapy in the second phase.Conclusion: This study found that both 10- and 14-day sequential therapies achieved a high eradication rate for first-line H. pylori therapy in clinical practice.

Background Failed biliary cannulation still poses a major challenge in patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP). To date, there is a lack of data on rates of Difficult Biliary Cannulation (DBC) in patients with distal malignant biliary obstruction (DMBO). Materials This was a retrospective study (09/2015 to 02/2019) of consecutive patients with DMBO that underwent ERCP in four Italian centers. The primary outcome was to evaluate the rate of DBC. Secondary outcomes were: cannulation failure, rate of adverse events (AEs), the predictive factors for DBC as well as for AEs. Results A total of 622 patients with DMBO, were included in the study, with 351(56,4%) matching the definition of DBC. One-hundred and two ERCP-related AEs occurred in 97 of 622 patients (15,6%). Subjects with DBC showed a higher risk for AEs (p = 0.02). The lack of pancreatitis prophylaxis (p = 0.03), diagnosis of cholangiocarcinoma (p = 0.02), the use of papillotomy (OR=1.98; 95%CI = 1.14–3.45) and the combination of two or more techniques for cannulation (OR = 2.88; 95%CI = 1.04–7.97) were associated with the occurrence of AEs. Conclusions According to the results of this study, patients with DMBO carries a higher rate of DBC thus requiring alternative techniques for biliary drainage. Furthermore, DBC carries a high risk for AEs. Further prospective multicentric studies are needed to confirm these data in this specific subgroup of patients.

Background and aimsArtificial intelligence has been shown to increase adenoma detection rate (ADR) as the main surrogate outcome parameter of colonoscopy quality. To which extent this effect may be related to physician experience is not known. We performed a randomised trial with colonoscopists in their qualification period (AID-2) and compared these data with a previously published randomised trial in expert endoscopists (AID-1).MethodsIn this prospective, randomised controlled non-inferiority trial (AID-2), 10 non-expert endoscopists (ResultsIn 660 patients (62.3±10 years; men/women: 330/330) with equal distribution of study parameters, overall ADR was higher in the CADe than in the control group (53.3% vs 44.5%; relative risk (RR): 1.22; 95% CI: 1.04 to 1.40; pConclusionsIn less experienced examiners, CADe assistance during colonoscopy increased ADR and a number of related polyp parameters as compared with the control group. Experience appears to play a minor role as determining factor for ADR.Trial registration numberNCT:04260321.

Background & aim Although acute lower GI bleeding (LGIB) represents a significant healthcare burden, prospective real-life data on management and outcomes are scanty. Present multicentre, prospective cohort study was aimed at evaluating mortality and associated risk factors and at describing patient management. Methods Adult outpatients acutely admitted for or developing LGIB during hospitalization were consecutively enrolled in 15 high-volume referral centers. Demographics, comorbidities, medications, interventions and outcomes were recorded. Results Overall 1,198 patients (1060 new admissions;138 inpatients) were included. Most patients were elderly (mean-age 74±15 years), 31% had a Charlson-Comorbidity-Index ≥3, 58% were on antithrombotic therapy. In-hospital mortality (primary outcome) was 3.4% (95%CI 2.5–4.6). At logistic regression analysis, independent predictors of mortality were increasing age, comorbidity, inpatient status, hemodynamic instability at presentation, and ICU-admission. Colonoscopy had a 78.8% diagnostic yield, with significantly higher hemostasis rate when performed within 24-hours than later (21.3% vs.10.8%, p = 0.027). Endoscopic hemostasis was associated with neither in-hospital mortality nor rebleeding. A definite or presumptive source of bleeding was disclosed in 90.4% of investigated patients. Conclusion Mortality in LGIB patients is mainly related to age and comorbidities. Although early colonoscopy has a relevant diagnostic yield and is associated with higher therapeutic intervention rate, endoscopic hemostasis is not associated with improved clinical outcomes [ClinicalTrial.gov number: NCT 04364412].

Background and Aims Since 2008, a plethora of research studies has compared the efficacy of water-assisted (aided) colonoscopy (WAC) and underwater resection (UWR) of colorectal lesions with standard colonoscopy. We reviewed and graded the research evidence with potential clinical application. We conducted a modified Delphi consensus among experienced colonoscopists on definitions and practice of water immersion (WI), water exchange (WE), and UWR. Methods Major databases were searched to obtain research reports that could potentially shape clinical practice related to WAC and UWR. Pertinent references were graded (Grading of Recommendations, Assessment, Development and Evaluation). Extracted data supporting evidence-based statements were tabulated and provided to respondents. We received responses from 55 (85% surveyed) experienced colonoscopists (37 experts and 18 nonexperts in WAC) from 16 countries in 3 rounds. Voting was conducted anonymously in the second and third round, with ≥80% agreement defined as consensus. We aimed to obtain consensus in all statements. Results In the first and the second modified Delphi rounds, 20 proposed statements were decreased to 14 and then 11 statements. After the third round, the combined responses from all respondents depicted the consensus in 11 statements (S): definitions of WI (S1) and WE (S2), procedural features (S3-S5), impact on bowel cleanliness (S6), adenoma detection (S7), pain score (S8), and UWR (S9-S11). Conclusions The most important consensus statements are that WI and WE are not the same in implementation and outcomes. Because studies that could potentially shape clinical practice of WAC and UWR were chosen for review, this modified Delphi consensus supports recommendations for the use of WAC in clinical practice.

Background and Aims Linked-color imaging (LCI), a new image-enhancing technology emphasizing contrast in mucosal color, has been demonstrated to substantially reduce polyp miss rate as compared with standard white-light imaging (WLI) in tandem colonoscopy studies. Whether LCI increases adenoma detection rate (ADR) remains unclear. Methods Consecutive subjects undergoing screening colonoscopy after fecal immunochemical test (FIT) positivity were 1:1 randomized to undergo colonoscopy with LCI or WLI, both in high-definition systems. Insertion and withdrawal phases of each colonoscopy were carried out using the same assigned light. Experienced endoscopists from 7 Italian centers participated in the study. Randomization was stratified by gender, age, and screening round. The primary outcome measure was represented by ADR. Results Of 704 eligible subjects, 649 were included (48.9% men, mean age ± standard deviation, 60.8 ± 7.3 years) and randomized to LCI (n = 326) or WLI (n = 323) colonoscopy. The ADR was higher in the LCI group (51.8%) than in the WLI group (43.7%) (relative risk, 1.19; 95% confidence interval, 1.01-1.40). The proportions of patients with advanced adenomas and sessile serrated lesions were, respectively, 21.2% and 8.6% in the LCI arm and 18.9% and 5.9% in the WLI arm (not significant for both comparisons). At multivariate analysis, LCI was independently associated with ADR, along with male gender, increasing age, and adequate (Boston Bowel Preparation Scale score ≥6) bowel preparation. At per-polyp analysis, the mean ± standard deviation number of adenomas per colonoscopy was comparable in the LCI and WLI arms, whereas the corresponding figures for proximal adenomas was significantly higher in the LCI group (.72 ± 1.2 vs .55 ± 1.07, P = .05) Conclusions In FIT-positive patients undergoing screening colonoscopy, the routine use of LCI significantly increased the ADR. (Clinical trial registration number: NCT03690297 .)

ObjectivesCOVID-19 has rapidly become a major health emergency worldwide. Patients with IBD are at increased risk of infection, especially when they have active disease and are taking immunosuppressive therapy. The characteristics and outcomes of COVID-19 in patients with IBD remain unclear.DesignThis Italian prospective observational cohort study enrolled consecutive patients with an established IBD diagnosis and confirmed COVID-19. Data regarding age, sex, IBD (type, treatments and clinical activity), other comorbidities (Charlson Comorbidity Index (CCI)), signs and symptoms of COVID-19 and therapies were compared with COVID-19 outcomes (pneumonia, hospitalisation, respiratory therapy and death).ResultsBetween 11 and 29 March 2020, 79 patients with IBD with COVID-19 were enrolled at 24 IBD referral units. Thirty-six patients had COVID-19-related pneumonia (46%), 22 (28%) were hospitalised, 7 (9%) required non-mechanical ventilation, 9 (11%) required continuous positive airway pressure therapy, 2 (3%) had endotracheal intubation and 6 (8%) died. Four patients (6%) were diagnosed with COVID-19 while they were being hospitalised for a severe flare of IBD. Age over 65 years (p=0.03), UC diagnosis (p=0.03), IBD activity (p=0.003) and a CCI score >1 (p=0.04) were significantly associated with COVID-19 pneumonia, whereas concomitant IBD treatments were not. Age over 65 years (p=0.002), active IBD (p=0.02) and higher CCI score were significantly associated with COVID-19-related death.ConclusionsActive IBD, old age and comorbidities were associated with a negative COVID-19 outcome, whereas IBD treatments were not. Preventing acute IBD flares may avoid fatal COVID-19 in patients with IBD. Further research is needed.

Background The recently introduced Hot AXIOS™ system for endoscopic ultrasound (EUS)-guided transenteric drainage has the potential to change interventional endoscopy significantly. The aim of our study was to assess the effectiveness and safety of this new type of lumen-apposing metal stent (LAMS) with cautery system for pancreatic collection, and gallbladder and biliary tree drainage. Methods We retrospectively reviewed consecutive patients undergoing EUS-guided drainage by LAMS with cautery system in a tertiary-care academic medical center between March 2014 and March 2017. All patients were included in our prospectively maintained institutional EUS database. The main outcome measures were technical success, clinical effectiveness, and adverse events. Results A total of 45 patients (20 men, mean age 69.6 years) underwent LAMS placement. Indications were pancreatic fluid collections (19 patients, 42.2%), acute cholecystitis (10 patients, 22.2%), and biliary drainage (16 patients, 35.5%). Technical success was achieved in all patients except one (97.7%). Clinical success was achieved in 86.4% (38/44) of cases and adverse events occurred in 5 (11.4%) of patients. Conclusions In our experience, EUS-guided LAMS placement performed by expert endoscopists was feasible and effective in the endoscopic management of pancreatic fluid collection, and biliary and gallbladder drainage. Optimization of transmural drainage by new dedicated devices could improve efficacy and safety in appropriately selected patients.

Background Linked color imaging (LCI) is a newly developed image-enhancing endoscopy technology that provides bright endoscopic images and increases color contrast. We investigated whether LCI improves the detection of neoplastic lesions in the right colon when compared with high definition white-light imaging (WLI). Methods Consecutive patients undergoing colonoscopy were randomized (1:1) after cecal intubation into right colon inspection at first pass by LCI or by WLI. At the hepatic flexure, the scope was reintroduced to the cecum under LCI and a second right colon inspection was performed under WLI in previously LCI-scoped patients (LCI–WLI group) and vice versa (WLI–LCI group). Lesions detected on first- and second-pass examinations were used to calculate detection and miss rates, respectively. The primary outcome was the right colon adenoma miss rate. Results Of the 600 patients enrolled, 142 had at least one adenoma in the right colon, with similar right colon adenoma detection rates (r-ADR) in the two groups (22.7 % in LCI–WLI and 24.7 % in WLI–LCI). At per-polyp analysis, double inspection of the right colon in the LCI–WLI and WLI–LCI groups resulted in an 11.8 % and 30.6 % adenoma miss rate, respectively (P Conclusions LCI could reduce the miss rate of neoplastic lesions in the right colon.

Background and study aims Single-center studies, which were retrospective and/or involved unblinded colonoscopists, have suggested that water exchange, but not water immersion, compared with air insufflation significantly increases the adenoma detection rate (ADR), particularly in the proximal and right colon. Head-to-head comparison of the three techniques with ADR as primary outcome and blinded colonoscopists has not been reported to date. In a randomized controlled trial with blinded colonoscopists, we aimed to evaluate the impact of the three insertion techniques on ADR. Patients and methods A total of 1224 patients aged 50 – 70 years (672 males) and undergoing screening colonoscopy were randomized 1:1:1 to water exchange, water immersion, or air insufflation. Split-dose bowel preparation was adopted to optimize colon cleansing. After the cecum had been reached, a second colonoscopist who was blinded to the insertion technique performed the withdrawal. The primary outcome was overall ADR according to the three insertion techniques (water exchange, water immersion, and air insufflation). Secondary outcomes were other pertinent overall and right colon procedure-related measures. Results Baseline characteristics of the three groups were comparable. Compared with air insufflation, water exchange achieved a significantly higher overall ADR (49.3 %, 95 % confidence interval [CI] 44.3 % – 54.2 % vs. 40.4 % 95 %CI 35.6 % – 45.3 %; P = 0.03); water exchange showed comparable overall ADR vs. water immersion (43.4 %, 95 %CI 38.5 % – 48.3 %; P = 0.28). In the right colon, water exchange achieved a higher ADR than air insufflation (24.0 %, 95 %CI 20.0 % – 28.5 % vs. 16.9 %, 95 %CI 13.4 % – 20.9 %; P = 0.04) and a higher advanced ADR (6.1 %, 95 %CI 4.0 % – 9.0 % vs. 2.5 %, 95 %CI 1.2 % – 4.6 %; P = 0.03). Compared with air insufflation, the mean number of adenomas per procedure was significantly higher with water exchange (P = 0.04). Water exchange achieved the highest cleanliness scores (overall and in the right colon). These variables were comparable between water immersion and air insufflation. Conclusions The design with blinded observers strengthens the validity of the observation that water exchange, but not water immersion, can achieve significantly higher adenoma detection than air insufflation. Based on this evidence, the use of water exchange should be encouraged. Trial registered at ClinicalTrials.gov (NCT02041507).

Background & Aims Blue-light imaging (BLI) is a chromoendoscopy technique that uses direct (not filtered) emission of blue light with short wavelength (410 nm) to increase visibility of microvascular pattern and superficial mucosa. A BLI-based classification system for colorectal polyps (also called BLI Adenomas Serrated International Classification, BASIC) has been created and was validated using still images or short videos. We aimed to validate BASIC in a clinical practice setting, using thresholds recommended by the American Society for Gastrointestinal Endoscopy for the resect and discard strategy as the reference standard. Methods We studied 333 patients (mean age, 62.7±8.1 y; 176 men) who underwent screening colonoscopy from January through July 2019. Six endoscopists trained in BASIC participated in the study. All detected diminutive polyps were characterized by real-time BLI and categorized as adenoma or non-adenoma according to BASIC. All polyps were removed and evaluated by histopathology. The BLI-directed surveillance intervals (based on high-confidence characterization of polyps 5 mm or smaller and pathology feature for others) were compared with histology-directed surveillance intervals, according to United States Multi-society Task Force and European Society of Gastrointestinal Endoscopy recommendations. We calculated negative-predictive values of optical real-time analysis of diminutive rectosigmoid adenomas. Results When we applied BASIC, 748 polyps smaller than 5 mm were categorized with 89% accuracy (95% CI, 85.9%–90.6%). BLI-directed surveillance was correct for 90% of patients according to the United States Multi-society task force criteria (95% CI, 86%–93%) and for 96% of patients according to European Society of Gastrointestinal Endoscopy criteria (95% CI, 93%–97%). The negative-predictive value for 302 polyps smaller than 5 mm, located in the rectosigmoid colon and evaluated with high confidence, based on histologic features of adenomatous polyps, was 91% (95% CI, 85%–95%). Conclusions Our analysis of data from 333 patients undergoing screen colonoscopies supports the validity of BASIC discriminating diminutive colorectal polyps with histologic features of adenomas from non-adenomas. This allows for the implementation of the resect and discard strategy based on BLI in clinical practice. ClinicalTrials.gov no: NCT03746171.

Background: Prospective studies about endoscopic retrograde cholangio-pancreatography (ERCP) in a community setting are rare. Aim: To assess success and complication rates of routinely-performed ERCP in a regional setting, and the priority quality indicators for ERCP practice. Methods: Prospective region wide observational study on consecutive patients undergoing ERCP during a 6-month period. A centralized online ERCP questionnaire was built and used for data storage. Primary quality indicators provided by the American Society of Gastrointestinal Endoscopy (ASGE) were considered. Results: 38 endoscopists from 18 centers performed a total of 2388 ERCP. The most common indication for ERCP was choledocholitiasis (54.8%) followed by malignant jaundice (22.6%). Cannulation of the desired duct was obtained in 2293 cases (96%) and ERCP was successful in 2176 cases (91.1%). Success and ERCP difficulty were significantly related to the experience of the operator (p = 0.001 and p < 0.001, respectively). ERCP difficulty was also significantly related to volume centers (p < 0.01). The overall complication rate was 8.4%: post-ERCP pancreatitis (PEP) occurred in 4.1% of procedures, bleeding in 2.9%, infection in 0.8%, perforation in 0.4%. Mortality rate was 0.4%. All the ASGE priority quality indicators for ERCP were confirmed. Conclusions: The procedural questionnaire proved to be an important tool to assess and verify the quality of routinely-performed ERCP performance in a community setting.

Background and aim: The safety of endoscopic resection of large colorectal lesions (LCLs) (≥20 mm) is clinically relevant. The aim of the present study was to assess the rate of post-resection adverse events (AEs) in a real-life setting. Patients and methods: In a prospective, multicentre, observational study, data from consecutive resections of LCLs over a 6-month period were collected in 24 centres. Patients were followed up at 15 days from resection for AEs. The primary endpoint was intra-procedural bleeding according to lesion morphology. Secondary endpoints were delayed bleeding and perforation. Patient and polyp characteristics, and polypectomy techniques were analysed with respect to the bleeding events. Results: In total, 1504 patients (female/male: 633/871, mean age, 66.1) with 1648 LCLs (29.1% pedunculated and 70.9% non-pedunculated lesions) were included. Overall, 168 (11.2%) patients had post-resection bleeding (8.5 and 2.0% immediate and delayed, respectively), while 15 (1.0%) cases of perforation occurred. Independent predictors of immediate bleeding for pedunculated lesions were bleeding prophylaxis (odds ratio (OR) 0.28, 95% confidence interval (CI) 0.13–0.62), simple polypectomy (versus endoscopic mucosal resection, OR 0.38, 95% CI 0.17–0.88) and inpatient setting (OR 2.21, 95% CI 1.07–5.08), while bleeding prophylaxis (OR 0.37, 95% CI 0.30–0.98), academic setting (OR 0.27, 95% CI 0.12–0.54) and size (OR 1.03, 95% CI 1.00–1.05) were predictors for those non-pedunculated. Indication for colonoscopy (screening versus diagnostic (OR 0.33, 95% CI 0.12–0.86)), antithrombotic therapy (OR 3.12, 95% CI 1.54–6.39) and size (OR 2.34, 95% CI 1.12–4.87) independently predicted delayed bleeding. Conclusions: A low rate of post-resection AEs was observed in a real-life setting, reassuring as to the safety of endoscopic resection of ≥2 cm colorectal lesions. Bleeding prophylaxis reduced the intra-procedural bleeding risk, while antithrombotic therapy increased delayed bleeding. CLINICALTRIAL: (NCT02694120).

Background and Aims: Most of the evidence supporting endoscopic submucosal dissection (ESD) comes from Asia. European data are primarily reported by specialized referral centers and thus may not be representative of common European ESD practice. The aim of this study is to understand the current state of ESD practice across Italian endoscopy centers. Methods: All Italian endoscopists who were known to perform ESD were invited to complete a structured questionnaire including: operator features and competencies, ESD training details and clinical outcomes over a 2-year period. Results: Twenty-nine operators from 23 centers (69% response rate) completed the questionnaire: 18 (62%) were 150 in 8 (27.5%). Colorectal ESD was predominant for operators with an experience >80 cases. En-bloc resection rates ranged from 77.2 to 97.2% depending on the anatomic location with an R0 resection rate range of 75.3–93.6%. ESD perforation rates in the colon and rectum were significantly lower when experience was >150 compared to 80–150 cases (p < 0.0001 and p = 0.006 for colon and rectum, respectively). Conclusion: ESD in Italy is performed by a significant number of operators. Overall, Italian endoscopists performing ESD have achieved a good competence level. However, there is much variability in training protocols, initial supervision of procedures, practice settings, case mix and procedural volume/year that are likely responsible for some of the suboptimal resectional outcomes and increased perforation risk, mainly in the colon. Standardized training programs, practice parameters and auditing of outcomes are required.

Adenoma detection rate (ADR) is the most robust colonoscopy quality metric and clinical studies have adopted it as the ideal method to assess the impact of technical interventions. Areas covered: We reviewed papers focusing on the impact of colonoscopy technical issues on ADR, including withdrawal time and technique, second evaluation of the right colon, patient positional changes, gastrointestinal assistant participation during colonoscopy, water-aided technique, optimization of bowel preparation and antispasmodic administration. Expert commentary: Overall, technical interventions are inexpensive, available worldwide and easy to implement. Some of them, such as the adoption of split dose regimen and slow scope withdrawal to allow a careful inspection, have been demonstrated to significantly improve ADR. Emerging data support the use of water-exchange colonoscopy. According to published studies, other technical interventions seem to provide only marginal benefit to ADR. Unfortunately, the available evidence has methodological limitations, such as small sample sizes, the inclusion of expert endoscopists only and the evaluation of single technical interventions. Additionally, larger studies are needed to clarify whether these interventions might have a higher benefit on low adenoma detectors and whether the implementation of a bundle of them, instead of a single technical maneuver, might have a greater impact on ADR.

Objective Although split regimen is associated with higher adenoma detection and is recommended for elective colonoscopy, its adoption remains suboptimal. The identification of patient-related barriers may improve its implementation. Our aim was to assess patients' attitude towards split regimen and patient-related factors associated with its uptake. Design In a multicentre, prospective study, outpatients undergoing colonoscopy from 8:00 to 14:00 were given written instructions for 4â €..L polyethylene glycol bowel preparation, offering the choice between split-dose and day-before regimens and emphasising the superiority of split regimen on colonoscopy outcomes. Uptake of split regimen and association with patient-related factors were explored by a 20-item questionnaire. Results Of the 1447 patients (mean age 59.2±13.5â €..years, men 54.3%), 61.7% and 38.3% chose a split-dose and day-before regimens, respectively. A linear correlation was observed between time of colonoscopy appointments and split-dose uptake, from 27.3% in 8:00 patients to 96% in 14:00 patients (p1â €..h (OR 0.55, 95% CI 0.38 to 0.79), low education level (OR 0.72, 95% CI 0.54 to 0.96) and female gender (OR 0.74, 95% CI 0.58 to 0.95) were inversely correlated with the uptake of split-dose. Overall, the risk of travel interruption and faecal incontinence was slightly increased in split regimen patients (3.0% vs 1.4% and 1.5% vs 0.9%, respectively; p=NS). Split regimen was an independent predictor of adequate colon cleansing (OR 3.34, 95% CI 2.40 to 4.63) and polyp detection (OR 1.46, 95% CI 1.11 to 1.92). Conclusion Patient attitude towards split regimen is suboptimal, especially for early morning examinations. Interventions to improve patient compliance (ie, policies to reorganise colonoscopy timetable, educational initiatives for patient and healthcare providers) should be considered. Trial registration number NCT02287051; pre-result.

Background Since infliximab (IFX) patent expiry in 2015, several IFX biosimilars have been licensed in EU for all indications, including inflammatory bowel diseases (IBD). IFX biosimilars currently available in Italy include CT-P13 and SB2, both of which demonstrated comparable efficacy, safety and immunogenicity with IFX originator in IBD patients. Safety and clinical efficacy of single switch from originator IFX to CT-P13 have also been confirmed in a prospective clinical trial. On the contrary, data regarding multiple therapeutic switching of IFX originator with CT-P13 and SB2 are currently lacking. Methods This study was aimed to evaluate the safety and efficacy of double switch from IFX originator to CT-P13 and subsequently to SB2 in patients with IBD. From November 2018 to May 2019, patients undergoing IFX double switch in 8 Centres in Lombardy were retrospectively analysed. The overall rate of IFX discontinuation, incidence and type of adverse events (AE) and proportion of patients on clinical remission over time were recorded. Data were compared with a control group of 66 IBD patients single switched from IFX originator to CT-P13. Results Fifty-two double-switched IBD patients were enrolled (63% M, mean age 41 years, 75% Crohn’s disease, 25% ulcerative colitis). Main indications for IFX therapy were moderate to severe disease (50%) and steroid-dependent disease (25%). The overall 24- and 48-week IFX discontinuation rates following second switch (CTP13->SB2) were 2% (95% CI 0–6%) and 14% (95% CI 3–25%), respectively. During a median follow-up of 40 weeks (18–48), 4 patients (12%) experienced a total of 6 AE (2 cutaneous, 2 infectious, 1 articular and 1 immunological), leading to IFX discontinuation in 3 cases (6%). No infusion reactions were observed. At week 24 following second switch, 49 (94%) patients were in clinical remission, the remaining 3 patients not being in remission already at the time of second switch. Only one patient lost response after week 24, 48 (92%) of patients being in clinical remission at the end of follow-up. No differences in IFX discontinuation, AE and clinical remission rates were found between double-switched and single-switched patients. No clinical parameters were found to predict safety and efficacy outcomes. Conclusion The study supports both safety and efficacy of the double switch from IFX originator to CT-P13 and SB2 in patients with IBD, and demonstrates its non-inferiority to a single switch strategy, with potential cost implications.

Blue-light imaging (BLI) is a new chromoendoscopy technique, potentially useful for differentiating neoplastic from nonneoplastic lesions. The present study was aimed at comparing BLI with high-definition white light (HDWL) in the real-time histology prediction of colon polyps 10 mm.Consecutive outpatients undergoing colonoscopy with the ELUXEO 7000 endoscopy platform and 760 series video colonoscopes (Fujifilm Co, Tokyo, Japan) who had at least 1 polyp 10 mm were randomized to BLI or HDWL for polyp characterization. The accuracy of high-confidence real-time histology prediction (adenoma vs not adenoma) by either BLI or HDWL for polyps 10 mm (primary end-point) and diminutive (≤5 mm) polyps was calculated, along with sensitivity, specificity, and positive and negative predictive values, with histopathology as the reference standard.A total of 483 polyps were detected in 245 randomized patients (125 and 120 in the BLI and HDWL arms, respectively). A total of 358 were diminutive, and 283 were adenomas. Overall, 222 (85.7%) and 193 (86.1%) polyps were characterized with high confidence by BLI and HDWL, respectively (P = .887), with an overall accuracy of 92% and 84%, respectively (P = .011). The accuracy was significantly higher by BLI than HDWL, also for diminutive polyps (92% vs 83%; P = .008). When BLI was used, the negative predictive value for diminutive rectosigmoid polyps was 88%, and the post-polypectomy surveillance interval was correctly attributed in 85.7% and 93.7% of patients, respectively, according to U.S. and European guidelines.BLI was superior to HDWL for the real-time prediction of histology in polyps 10 mm. A BLI-dedicated classification might further improve the endoscopist performance. (Clinical trial registration number: NCT03274115.).

BACKGROUND We report a prospective, nationwide cohort evaluating the safety and effectiveness of CT-P13. METHODS A structured database was used to record serious adverse events (SAEs), clinical remission/response, inflammatory biomarkers (CRP and calprotectin), and endoscopic findings. RESULTS Eight hundred ten patients with inflammatory bowel disease (IBD) (452 Crohn's disease [CD]) were enrolled. Four hundred fifty-nine patients were naive to anti-TNFα (group A), 196 had a previous exposure (group B), and the remaining 155 were switched to CT-P13 (group C). All patients were included in the safety evaluation with a mean follow-up of 345 ± 215 days and a total number of 6501 infusions. One hundred fifty-four SAEs were reported (19%), leading to cessation of the biosimilar in 103 subjects (12.7%). Infusion reactions were 71, leading to cessation of the biosimilar in 53 subjects (6.5%), being significantly more frequent in patients pre-exposed to anti-TNFα (P = 0.017). The efficacy of therapy was calculated in 754 IBD patients, with a mean follow-up of 329 ± 202 days. Forty-eight patients had a primary failure (6.4%), and 188 (25.6%) lost response during follow-up. Six hundred twenty-eight (364 CD) and 360 IBD patients (222 CD) completed the follow-up at 6 and 12 months, respectively. At 12 months, patients without loss of response were 71%, 64%. and 82% in groups A, B, and C, respectively (log rank P = 0.01). Clinical/endoscopic scores and inflammatory biomarkers dropped significantly in CD and UC patients (P = 0.01 and P < 0.0001) compared with baseline. CONCLUSIONS In this large prospective cohort, no further signals of difference in safety and effectiveness of CT-P13 in IBD has been observed.

To test the hypothesis that water exchange (WE) significantly increases adenoma detection rates (ADR) compared with water immersion (WI).Low ADR was linked to increased risk for interval colorectal cancers and related deaths. Two recent randomized controlled trials of head-to-head comparison of WE, WI, and traditional air insufflation (AI) each showed that WE achieved significantly higher ADR than AI, but not WI. The data were pooled from these 2 studies to test the above hypothesis.Two trials (5 sites, 14 colonoscopists) that randomized 1875 patients 1:1:1 to AI, WI, or WE were pooled and analyzed with ADR as the primary outcome.The ADR of AI (39.5%) and WI (42.4%) were comparable, significantly lower than that of WE (49.6%) (vs. AI P=0.001; vs. WI P=0.033). WE insertion time was 3 minutes longer than that of AI (P0.001). WE showed significantly higher detection rate (vs. AI) of the10 mm advanced adenomas. Right colon combined advanced and sessile serrated ADR of AI (3.4%) and WI (5%) were comparable and were significantly lower than that of WE (8.5%) (vs. AI P0.001; vs. WI P=0.039).Compared with AI and WI, the superior ADR of WE offsets the drawback of a significantly longer insertion time. For quality improvement focused on increasing adenoma detection, WE is preferred over WI. The hypothesis that WE could lower the risk of interval colorectal cancers and related deaths should be tested.

This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE). The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system 1 2 was adopted to define the strength of recommendations and the quality of evidence. Main recommendations 1 ESGE recommends endoscopic en bloc resection for superficial esophageal squamous cell cancers (SCCs), excluding those with obvious submucosal involvement (strong recommendation, moderate quality evidence). Endoscopic mucosal resection (EMR) may be considered in such lesions when they are smaller than 10 mm if en bloc resection can be assured. However, ESGE recommends endoscopic submucosal dissection (ESD) as the first option, mainly to provide an en bloc resection with accurate pathology staging and to avoid missing important histological features (strong recommendation, moderate quality evidence). 2 ESGE recommends endoscopic resection with a curative intent for visible lesions in Barrett’s esophagus (strong recommendation, moderate quality evidence). ESD has not been shown to be superior to EMR for excision of mucosal cancer, and for that reason EMR should be preferred. ESD may be considered in selected cases, such as lesions larger than 15 mm, poorly lifting tumors, and lesions at risk for submucosal invasion (strong recommendation, moderate quality evidence). 3 ESGE recommends endoscopic resection for the treatment of gastric superficial neoplastic lesions that possess a very low risk of lymph node metastasis (strong recommendation, high quality evidence). EMR is an acceptable option for lesions smaller than 10 – 15 mm with a very low probability of advanced histology (Paris 0-IIa). However, ESGE recommends ESD as treatment of choice for most gastric superficial neoplastic lesions (strong recommendation, moderate quality evidence). 4 ESGE states that the majority of colonic and rectal superficial lesions can be effectively removed in a curative way by standard polypectomy and/or by EMR (strong recommendation, moderate quality evidence). ESD can be considered for removal of colonic and rectal lesions with high suspicion of limited submucosal invasion that is based on two main criteria of depressed morphology and irregular or nongranular surface pattern, particularly if the lesions are larger than 20 mm; or ESD can be considered for colorectal lesions that otherwise cannot be optimally and radically removed by snare-based techniques (strong recommendation, moderate quality evidence).

Acute gastrointestinal bleeding represents the most common adverse event associated with the use of oral anticoagulant therapy. Due to increasing prescription of anticoagulants worldwide, gastroenterologists are more and more called to deal with bleeding patients taking these medications. Their management is challenging because several issues have to be taken into account, such as the severity of bleeding, the intensity of anticoagulation, the patient's thrombotic risk and endoscopy findings. The recent introduction into the marketplace of new direct oral anticoagulants, for whom specific reversal agents are still lacking, further contributes to make the decision-making process even more demanding. Available evidence on this topic is limited and practice guidelines by gastroenterology societies only marginally address key issues for clinicians, including when and how to reverse coagulopathy, the optimal timing of endoscopy and when and how to resume anticoagulation thereafter. The present paper reviews the evidence in the literature and provides practical algorithms to support clinicians in the management of patients on anticoagulants who present with acute gastrointestinal bleeding.

Background and study aims: It has been proposed that the use of narrow-band imaging (NBI) for real-time histological assessment to determine postpolypectomy surveillance intervals is a cost-effective approach to the management of diminutive polyps. However, significant discrepancies in NBI performance have been observed among endoscopists; hence, professional societies recommend training, monitoring, and auditing. The aim of the present study was to evaluate the performance of real-time optical diagnosis for diminutive polyps after the inclusion of this approach in an internal quality assurance program, in order to assess its applicability in clinical practice Patients and methods: Four endoscopists attended periodic training sessions on NBI assessment of polyp histology before and during the study. Performance was audited and periodic feedback was provided. The accuracy of high-confidence NBI evaluation for polyps ≤ 5 mm in predicting surveillance intervals according to the European and US guidelines, and the negative predictive value (NPV) for adenoma in the rectosigmoid were calculated and compared with recommended thresholds (90 % agreement and 90 % NPV, respectively). Results: Overall, 284 outpatients (mean age 61.3 ± 18.2 years; 63 % males) were enrolled. A total of 656 polyps were detected, 465 of which (70.9 %) were diminutive (70.5 % adenomas). Sensitivity, specificity, positive and negative predictive values, and accuracy of high-confidence NBI predictions for adenoma in diminutive lesions were 95.3 %, 83.5 %, 93.5 %, 87.6 %, and 91.9 %, respectively. High-confidence characterization of diminutive polyps predicted the correct surveillance interval in 95.8 % and 93.3 % of cases according to European and American guidelines, respectively. NPV for adenoma in the rectosigmoid was 91.3 % Conclusions: For community settings in which endoscopists are adequately trained and performance is periodically audited, real-time optical diagnosis for diminutive polyps is sufficiently accurate to avoid postpolypectomy histological examination of resected lesions, or to leave rectosigmoid hyperplastic polyps in place. Trial registered at ClinicalTrials.gov (NCT02196402).

A split-dose (SD) regimen is crucial for colonoscopy quality. Compliance with SD for early morning colonoscopy is generally poor. The present study evaluated whether pre-colonoscopy counselling, in addition to a dedicated leaflet, might increase SD uptake.Consecutive 50-69-year-old patients undergoing screening colonoscopy before 10 a.m. were randomized to either receive written information only on bowel preparation (Written Group, WG) or written and oral instructions (Written and Oral Group, WaOG). The leaflet strongly encouraged SD adoption. The primary endpoint was the number of patients adopting SD in each group. The secondary endpoints were predictors of SD uptake, compliance with preparation schemes and cleansing adequacy.A total of 286 patients (143 WG, 143 WaOG) were enrolled (mean age 59.6 ± 6.1 years, men 49.3%). SD was adopted by 114 and 125 patients in the WG and WaOG, respectively (79.7% versus 87.4%,Our leaflet guaranteed satisfactory uptake of SD and excellent adherence to the preparation scheme for early morning colonoscopy. Its use might marginalize the need for additional oral instructions, particularly in open-access settings.

Background. Granulocyte-monocyte apheresis has been proposed for the treatment of ulcerative colitis, although it is limited by costs and variability of results. Aim. To assess effectiveness of granulocyte-monocyte apheresis in patients with steroid-dependent, azathioprine-intolerant/resistant moderate ulcerative colitis. Methods. Consecutive patients fulfilling inclusion criteria were prospectively enrolled, treated by apheresis, and followed up for 12 months. The primary end point of the study was steroid-free clinical remission at 12 months, with no need for biologic therapy or surgery. Results. From January to December 2013, 33 patients were enrolled. After one year of follow-up, 12 (36%) patients had clinical remission, were steroid-free, and had no need for biological therapy or surgery; 3 (9%) cases showed a clinical response (but not clinical remission). Moreover, 12 (36%) patients required biologic therapy, 4 (12%) underwent colectomy, and in the other 2 (6%) a reduction, but not withdrawal, of steroid dose was achieved. Conclusions. Our study shows that a standard course of granulocyte-monocyte apheresis is associated with a 36% steroid-free clinical remission in patients with steroid-dependent, azathioprine-intolerant or resistant moderate ulcerative colitis. Apheresis might represent an alternative to biologic therapy or surgery in this specific subgroup of patients. This trial is registered with Clinicaltrial.gov NCT03189888.