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Background: Endoscopic ultrasound (EUS) is important for the evaluation of patients with common bile duct (CBD) dilation., Aims: The purpose of this study was to evaluate the diagnostic performance of EUS for CBD dilation in patients with negative initial studies., Methods: This was a retrospective cohort study that included patients who underwent EUS for CBD dilation (≥ 7 mm if intact anatomy or ≥ 10 mm if prior cholecystectomy) in the absence of pathology on previous ultrasonography (US), computed tomography (CT), and/or magnetic resonance cholangiopancreatography (MRCP)., Results: A total of 109 patients were included, among whom 41 had a positive EUS: 33 choledocholithiasis (30.3%), 6 chronic pancreatitis (5.5%), and 2 ampullary cancer (1.8%). If the EUS was negative, no pathology was found during 1-year follow-up. Older age was associated with positive EUS (79 versus 71 years, p = 0.030). Patients with jaundice, cholelithiasis, and altered liver biochemistry were 16.2 (p = 0.002), 3.1 (p = 0.024), and 2.9 (p = 0.009) times more likely to have positive EUS, respectively. A total of 53 patients had a negative MRCP (48.6%); those with biliary abdominal pain and jaundice were 15.5 (p < 0.001) and 20.0 (p = 0.007) times more likely to have positive EUS, respectively. Considering asymptomatic patients with normal liver tests, CBD diameter ≥ 10 mm in US and ≥ 11 mm in CT can predict a positive EUS (AUC 0.754, p = 0.047 and AUC 0.734, p = 0.048)., Conclusions: EUS is a useful diagnostic method for patients with unexplained CBD dilation, even if negative MRCP, and especially in patients with older age, abdominal pain, jaundice, cholelithiasis, and/or altered liver biochemistry. CBD diameter in US and CT had a moderate discriminative ability in predicting positive EUS in asymptomatic patients without altered liver biochemistry., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Competing Interests: B. Rosa has received consultancy fees from Medtronic, unrelated to the current work. T. Cúrdia Gonçalves, M.J. Moreira, F. Dias de Castro, B. Sousa-Pinto, M. Dinis-Ribeiro, and J. Cotter declare that they have no conflict of interest.

Background: Pan-intestinal capsule endoscopy (PCE) evaluates the small bowel and colon noninvasively. This study evaluated diagnostic accuracy and safety of PCE vs. colonoscopy as first-line examination in suspected mid-lower gastrointestinal bleeding (MLGIB)., Methods: In this prospective, single-center, single-blinded cohort study, consecutive patients with suspected MLGIB underwent PCE followed by same-day colonoscopy. Diagnostic accuracy for potentially hemorrhagic lesions (PHLs; combined diagnosis by PCE + colonoscopy) and incidence of adverse events were assessed., Results: 100 patients were included (median age 70 [range 18-92] years; 65% female). PHLs were diagnosed in 46 patients, including small-bowel and/or colon angioectasias in 32. PCE correctly identified 54 individuals without PHLs, and 95.7% (44/46) of those with PHLs vs. 50.0% (23/46) for colonoscopy (P<0.01). PHLs were detected by PCE alone in 65.2% (30/46), both examinations in 28.3% (13/46), and colonoscopy alone in 6.5% (3/46). PHLs were diagnosed at the ileocolonic region in 28% of patients, with PCE diagnosing 25/28 cases (89.3%) and colonoscopy diagnosing 23/28 (82.1%; P=0.13). Interventional procedures were performed at colonoscopy in 13/81 patients with iron-deficiency anemia (16.0%) vs. 6/19 patients with overt bleeding (31.6%; P<0.01). No significant adverse events occurred with PCE vs. 2% with colonoscopy., Conclusions: In patients with MLGIB, PCE avoided further invasive procedures in >50% of patients. PCE was safe and more effective than colonoscopy in identifying PHL both in the small bowel and colon. These results support the potential use of PCE as first-line examination in patients with suspected MLGIB., Competing Interests: B. Rosa has received consultancy fees from Medtronic, unrelated to the current work. T. Cúrdia Gonçalves, M.J. Moreira, F. Dias de Castro, B. Sousa-Pinto, M. Dinis-Ribeiro, and J. Cotter declare that they have no conflict of interest., (Thieme. All rights reserved.)

Background: Although endoscopic ultrasound (EUS) plays a critical role in the management of subepithelial lesions (SEL) of upper gastrointestinal tract many can be classified solely by a thorough upper gastrointestinal endoscopy (UGE) which can reduce the burden of additional studies., Aims: Analyze the impact of a stepwise approach starting with a second-look UGE before the decision of EUS in patients referred to our center with suspected SEL., Methods: Retrospective cohort study which included all adult patients referred to our center between 2015 and 2020 with suspected SEL.Second-look UGE evaluated the location, size, color, surface characteristics, movability and consistency of the SEL and bite-on-bite biopsies were performed. Decisions on SEL management and follow-up were collected., Results: A total of 193 SEL (190 patients) were included. At the index-UGE, stomach was the most frequent location (n = 115;59.6%). Most patients performed a second-look UGE (n = 180; 94.7%). A minority was oriented directly to EUS (n = 8;4.2%) or endoscopic resection (n = 2; 1.1%). In patients who underwent a second-look UGE, SEL were excluded in 25 (13.9%) and 21 (11.7%) did not need further work-up. The remaining patients were submitted to EUS (n = 88;48.9%), surveillance by UGE (n = 44; 24.4%) or endoscopic resection (n = 2; 1.1%)., Conclusion: Systematically performing a second-look UGE, in patients referred with suspected SEL, safely preclude the need for subsequent investigation in approximately one-fourth of the patients. As UGE is less invasive and more readily available, we suggest that a second-look UGE should be the initial approach in SEL management., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Introduction: There is scarce data focused on recurrence neoplasia rate (RR) after piecemeal endoscopic mucosal resection (pEMR) of 10-19 mm non-pedunculated colorectal lesions (NPL). We aimed to analyze the RR after pEMR of 10-19 mm NPL, identify risk factors for its development and compare it with RR after pEMR of ≥ 20 mm NPL., Methods: Retrospective cohort-study including all ≥10 mm NPL resected by pEMR in our center between 2018-2022 with an early repeat colonoscopy (ERC). RR was defined as recurrence neoplasia identified in the ERC EMR scar with virtual chromoendoscopy or histological confirmation., Results: A total of 444 NPL were assessed, 124 (27.9%) with 10-19 mm. In the ERC, performed a median of 6 months after pEMR, RR was significantly lower for 10-19 mm NPL compared to ≥ 20 mm NPL (13/124 vs 68/320, p  = 0.005). In subgroup analysis, RR after pEMR of 15-19 mm NPL was significantly higher compared to 10-14 mm NPL (13/98 vs 0, p  = 0.041) but not significantly different compared to ≥ 20 mm NPL (13/98 vs 68/320, p  = 0.073). In multivariable analysis, size of NPL (HR 1.501, 95% CI 1.012-2.227, p  = 0.044) was the only independent risk factor identified for RR for 10-19 mm NPL., Conclusion: Although the early RR after pEMR of 10-19 mm NPL is significantly lower compared to ≥ 20 mm NPL, it is non-negligible (10.5%) and appears to be the highest among 15-19 mm NPL. The size of the lesion was the only independent risk factor for RR. Our findings should be accounted in the selection of the most appropriate post-polypectomy endoscopic surveillance.

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection may lead to the development of the novel coronavirus disease (coronavirus disease 2019 [COVID-19]). Scarce data are available regarding safety and efficacy of SARS-CoV-2 vaccination in inflammatory bowel disease (IBD) patients, which may present differences between subgroups. Lower humoral immunological response could require additional booster injections., Methods: This is a prospective study including adult patients with IBD after complete vaccination against SARS-CoV-2 infection with BioNTech vaccine. Patients with previous SARS-CoV-2 infection were excluded. A control group with healthy individuals matched for age and sex was also analyzed. Blood samples were collected 30 days after complete vaccination to quantify immunoglobulin G (IgG) antibody titers against SARS-CoV-2 in both groups., Results: The final sample included 81 IBD and 32 non-IBD patients, 55 (48.7%) of them women, with a mean age of 40.2 ± 13.0 years. From IBD patients, 58 (71.6%) had Crohn's disease and 23 (28.4%) had ulcerative colitis. IBD patients had significantly lower median anti-SARS-CoV-2 IgG levels when compared with the control group (6479 [interquartile range (IQR) 1830-11883, 10 053] AU/mL vs 13 061 [IQR 2826-21427, 15 539] AU/mL; P = .003). Regarding IBD medication, significant lower levels of SARS-CoV-2 IgG antibodies when compared with control subjects were observed in patients treated with thiopurines (5423 [IQR 3109-13369, 10 260] AU/mL; P = .011), methotrexate (834 [IQR 507-3467, 4155] AU/mL; P = .002), anti-tumor necrosis factor α agents (5065 [IQR 1033-11669, 10 636] AU/mL; P = .001), and corticosteroids (548 AU/mL; P = .001). The incidence of SARS-CoV-2 infection after vaccination was also significantly higher in patients treated with these agents., Conclusions: IBD patients treated with immunomodulators, anti-tumor necrosis factor α agents and corticosteroids presented significantly lower anti-SARS-CoV-2 IgG levels following complete vaccination when compared with healthy control subjects. These findings support the benefit of additional booster injections in this population., (© The Author(s) 2022. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Pancreatitis is the most common complication following endoscopic retrograde cholangiopancreatography (ERCP). In patients receiving NSAID prophylaxis, we aimed to assess whether periprocedural intensive hydration (IH) resulted in a lower incidence of PEP when compared to standard hydration (SH)., Material and Methods: Prospective, single-center, double-blinded randomized controlled trial, with inclusion of consecutive patients submitted to inaugural ERCP between January 2015 and December 2018. Patients were randomized on admission, in a 1:1 ratio, to either SH-Ringer's Lactate (RL) at a rate of 1.5 mL/kg/h during and for 8 h following the procedure, or IH-RL at a rate of 3 mL/kg/h during and for 8 h following the procedure, with an additional bolus of 20 mL/kg at the end of the procedure. PEP incidence and severity were assessed according to the Atlanta Guidelines., Results: A total of 155 patients were randomized (83 to IH, 72 to SH). PEP was observed in 8,4% (n = 13) of the patients, and was significantly less frequent in IH patients when compared to SH (3,6% vs 13,9%, P = 0,021; relative risk 0.233 [95% IC, 0.061-0.881]); five patients in the SH group developed moderate to severe PEP, in contrast to 0 patients in the IH group (6.9% vs 0.0%, P = 0,020)., Conclusions: Intensive hydration significantly decreased the risk of post-ERCP pancreatitis by four-fold. Moreover, no cases of moderate or severe pancreatitis were observed in patients submitted to this intervention. Associated with nonsteroidal anti-inflammatory drugs, intensive hydration could constitute a new standard of care for patients undergoing ERCP., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Optimal strategies for using small-bowel capsule endoscopy (SBCE) in established small-bowel Crohn's disease (CD) remain uncertain. Mucosal healing (MH) has emerged as a valuable predictor of a flare-free disease. We aimed to evaluate the occurrence of disease flare on patients with small-bowel CD and MH, as well as to create a score identifying patients in higher risk for this outcome., Methods: We analyzed consecutive patients submitted to SBCE for assessment of MH and included those where MH was confirmed. The incidence of disease flare was assessed during follow-up (minimum 12 months). A score predicting disease flare was created from several analyzed variables., Results: From 47 patients with MH, 12 (25.5%) had a flare (versus 48.3% in excluded patients without MH; p = 0.01). Age ≤ 30 years (OR  = 70; p  = 0.048), platelet count ≥ 280 × 10 3 /L (OR  = 12.24; p  =  0.045) and extra-intestinal manifestations (OR  =  11.76; p  =  0.033) were associated with increased risk of CD flare during the first year after SBCE with MH. These variables were used to compute a risk-predicting score-the APEX score-which assigned the patients to having low (0-3 points) or high-risk (4-7 points) of disease flare and had excellent accuracy toward predicting disease relapse (AUC  =  0.82; 95%CI 0.64-0.99)., Conclusion: Patients with small-bowel CD and MH were not free of disease flares on the subsequent year, despite presenting lower rates when compared to those without MH. The APEX score demonstrated excellent accuracy at stratifying patients relapse risk and guiding further therapeutic options for patients achieving MH., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objectives: Azathioprine (AZA)-induced pancreatitis (AIP) is a common, idiosyncratic adverse effect whose incidence and risk factors data in inflammatory bowel disease (IBD) patients are not fully clarified. We aimed to establish the incidence, clinical course and identify risk factors for AIP., Methods: A retrospective study including all IBD patients on AZA between January 2013 and July 2020 was conducted. Patients with AIP were considered., Results: Azathioprine-induced pancreatitis occurred in 33 patients (7.5%; 442 patients on AZA). The mean time receiving AZA until AIP was 25 days, with a mean dose of 88 mg. All patients had a mild course of disease, which resolved with suspension of AZA and with no complications. Smoking (P = 0.02), single daily dose of AZA (P < 0.001), and concomitant budesonide (P = 0.001) were risk factors for AIP. In multivariate analysis, concomitant treatment with budesonide (odds ratio, 5.3; P = 0.002) and single daily dose of AZA (odds ratio, 3.8; P = 0.002) were the only predictors of AIP., Conclusions: Although AIP was a relatively common adverse effect, it presented a mild course in all patients. Smoking, concomitant use of budesonide, and single-dose regimen of AZA should be avoided in IBD patients treated with AZA., Competing Interests: The authors declare no conflict of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: A recent meta-analysis has suggested that proton pump inhibitor (PPI) therapy is associated with lower clinical remission rates and a higher number of hospitalizations in patients with inflammatory bowel disease (IBD) under infliximab therapy. We aimed to assess if these differences kept their significance when adjusted for other possible confounders., Methods: Cohort study of consecutive patients with Crohn's disease (CD) and Ulcerative Colitis (UC) under infliximab therapy. A minimum follow-up of 54 weeks after introduction of infliximab treatment was required. The analyzed outcomes were deep remission at week 54 and the need of IBD-related hospitalization, corticosteroid treatment or abdominal surgery under infliximab treatment. Collected possible confounders were age, gender, smoking habits, perianal disease, extra-intestinal manifestations, familiar history of IBD and concomitant use of immunomodulators., Results: Our final sample included 104 patients, 56 (53.8%) of them females, with a mean age of 38.2±13.1 years. From these, 77 (74.0%) had CD and 27 (26.0%) had UC. PPI therapy was described in 21 (20.2%) of the patients under infliximab treatment. On univariate analysis, PPI users were found to have significantly lower rates of deep remission at week 54 (7.7 vs 28.3%; p = 0.034) and higher IBD-related hospitalization rates (47.6 vs 21.7%; p = 0.034). No differences were found regarding the need of corticosteroid therapy (4.8 vs 10.8%; p = 0.398) or abdominal surgery (33.7 vs 21.7; p = 0.201). When adjusted for the collected confounders by multivariate analysis, while not significantly influencing deep remission at week 54 (OR = 0.16; 95%CI = 0.02-1.63; p = 0.121), concomitant PPI therapy was a significant independent risk factor for IBD-related hospitalization (OR = 3.22; 95%CI = 1.11-9.34; p = 0.04)., Conclusion: Despite not conducting to significantly different deep remission rates, concomitant PPI therapy was associated with a three-fold increase in hospitalization rates in IBD patients under infliximab treatment, even when adjusted for classical risk factors for adverse outcomes in IBD. These findings emphasize the importance of restricting PPI treatment to those with a clear clinical indication, especially in this set of patients., (Copyright © 2021 by The American College of Gastroenterology.)

Background: Treatment delay in patients admitted with acute severe ulcerative colitis (ASUC) are associated with increased mortality. Therefore, it is essential to identify on admission patients at high-risk of steroid nonresponse who may benefit from earlier second-line treatment or surgical intervention. Recently, the ACE index was developed and includes 3 variables at admission: C-reactive protein (CRP) ≥50mg/dL, albumin ≤30g/L and endoscopic severity (Mayo endoscopic score=3), and ranges between 0-3 points. An index of 3 has been shown to be useful to identify patients with acute ulcerative colitis with high-risk of steroid nonresponse., Objectives: To assess the ACE index performance in predicting steroids response in ASUC., Methods: Retrospective study including consecutive admissions for ASUC according to Truelove and Witts definition between January 2005 and December 2020. The ACE index was calculated and its accuracy for predicting response to steroids on admission in ASUC was assessed through the area under the curve (AUC)., Results: Sixty-five patients were included of whom 78.5% responded to steroids. Mean CRP (p = 0.01), albumin (p=0.02) and endoscopic severity score (p < 0.001) at admission were significantly different between responders and nonresponders, as opposed to Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score (p = 0.32). Median ACE index was 2. The ACE index was a predictor of steroids response (AUC 0.789; p = 0.001); 50.0% of patients with an index of 3 did not respond to steroids, and 86.3% of patients with an index inferior to 3 responded to steroids (positive predictive value 50.0%; negative predictive value of 86.3%)., Conclusion: The ACE index is an accurate predictor of steroids response on admission in ASUC. However, in our study, the ACE index doesn´t discriminate whose high-risk patients would benefit from earlier therapeutic escalation, since only 50.0% of patients with an index of 3 did not respond to steroids., (Copyright © 2021 by The American College of Gastroenterology.)

Background and study aims  Polyethylene glycol (PEG) bowel preparations are effective but associated with high ingestion volume. In this study, 1-L PEG and 2-L PEG preparations were compared in a randomized, colonoscopist-blinded, single-center trial. Patients and methods  Patients were aged > 18 years, required colonoscopy, and provided informed consent. Randomization was 1:1 to 1-L PEG or 2-L PEG, based on hospital identification number (odd or even). Preparations were administered using same-day dosing adjusted for colonoscopy start time. The primary endpoint was successful bowel preparation on the Boston Bowel Preparation Scale (BBPS) (no segment scored < 2). Results  A total of 852 patients were randomized. In the intention-to-treat (ITT) population, significantly more patients had diabetes in the 2-L PEG arm, resulting in the creation of the modified-ITT population (mITT) that excluded diabetic patients to correct the imbalance (1-L PEG, n = 239; 2-L PEG, n = 238). In the mITT, there was no significant difference in successful cleansing between 1-L PEG and 2-L PEG (88.3 % vs. 82.4 %; P  = 0.067). Excellent cleansing (BBPS 7-9; no segment < 2) was significantly improved with 1-L PEG (60.7 % vs. 50.4 %; P  < 0.024), as were mean scores in the right and left colon (right: 2.47 vs. 2.30; P  < 0.008; left: 2.55 vs. 2.39; P  = 0.008). Adverse events were mild to moderate in intensity and none resulted in discontinuation. Rates of nausea and vomiting were significantly higher with 1-L PEG, but that did not affect successful cleansing. Conclusions  The lower-volume 1-L PEG was associated with higher levels of excellent bowel cleansing and greater mean segmental scores on the BBPS than 2-L PEG., Competing Interests: Competing interests Dr. Rosa has a consulting services agreement with Medtronic., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background: small-bowel capsule endoscopy (SBCE) is the gold standard for the study of small-bowel bleeding (SBB). Recent studies suggest that longer small-bowel transit times (SBTT) may be associated with a higher diagnostic yield of SBCE., Aim: the aim of the study was to investigate if longer SBTT is a predictive factor of positive findings on SBCE in a population that underwent SBCE for suspected SBB., Methods: a retrospective single-center study including consecutive SBCEs between May 2012 and May 2019, due to suspected SBB. A positive SBCE was considered in the presence of lesions with high bleeding potential such as ulcers, angioectasias, and tumors (P2 lesions, according to the Saurin classification)., Results: we included 372 patients, 65.9 % female, with a median age of 67 (IQR: 19-97) years. We observed that patients with P2 lesions (n = 131; 35.2 %) in SBCE exhibited a longer SBTT (p = 0.01), were older (p < 0.001), were more frequently male (p = 0.019), and suffered more frequently from arterial blood hypertension (p = 0.011), diabetes (p = 0.042), chronic kidney disease (p = 0.003), and heart failure (p = 0.001). In the logistic analysis, significant predictive factors for the presence of P2 lesions included age (OR: 1.027; 95 % CI: 1.009-1.045; p = 0.004), SBTT (OR: 1.002; 95 % CI: 1.001-1.005; p = 0.029), and male gender (OR: 1.588; 95 % CI: 1.001-2.534; p = 0.049)., Conclusions: patients with longer SBTT had higher rates of lesions with high bleeding potential (P2). SBTT along with previously well-defined factors such as age and male gender were the only independent predictive factors for the presence of P2 lesions. These findings may suggest that a slower passage of the capsule through the small bowel may allow a better diagnostic yield for significant lesions.

Background and Aims: Terminal ileitis is a common condition and may be associated with a wide variety of diseases, mostly Crohn's disease. Although small bowel capsule endoscopy (SBCE) is a valuable diagnostic tool for small-bowel diseases, data regarding its diagnostic impact on isolated terminal ileitis are sparse. The aim of this study was to evaluate the diagnostic value of SBCE for isolated terminal ileitis detected during ileocolonoscopy and to assess predictive factors for Crohn's disease diagnosis., Methods: This is a retrospective study including consecutive patients undergoing SBCE after diagnosis of terminal ileitis without colonic mucosal abnormalities on ileocolonoscopy between January 2016 and September 2019., Results: This included 102 patients with isolated terminal ileitis on ileocolonoscopy. Positive findings on SBCE were found in 82.4% of patients. After performing SBCE, 61.8% of patients had a final diagnosis, being Crohn's disease the most common (34.3%), followed by NSAIDs enteropathy (12.7%). Extraintestinal manifestations (P = 0.003), weight loss (P = 0.02), abnormal imaging (P = 0.04) and positive SBCE findings (P = 0.001) were independently associated with Crohn's disease diagnosis. Regarding SBCE, presence of proximal small-bowel disease (P = 0.02), diffuse findings (P = 0.002) and moderate to severe inflammatory activity (Lewis score ≥ 790) (P < 0.001) were independently associated with Crohn's disease diagnosis., Conclusion: SBCE is a valuable tool that should be systematically used in patients with isolated terminal ileitis on ileocolonoscopy, since it revealed a high diagnostic yield, supporting a definite diagnosis in almost two-thirds of patients, and Crohn's disease diagnosis in approximately one-third of patients. A diagnosis of Crohn's disease should be considered when a patient with terminal ileitis on ileocolonoscopy shows proximal involvement, diffuse findings and/or moderate to severe inflammatory activity on SBCE., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Perianal disease is associated with a disabling course of Crohn's disease (CD). We aim to study the impact of perianal disease on CD remission rates, after a 1-year course of infliximab in combination therapy with azathioprine., Methods: This was a retrospective, single-center cohort study, including consecutive CD patients on combination therapy, followed for 1 year since induction. The outcome variable was split into clinical and endoscopic remissions. The correlation toward the outcome variable was assessed with univariate and multivariate analysis and a survival assessment, using SPSS software., Results: We assessed 74 CD patients, of whom 41 (55.4%) were female, with a mean age of 36 years. Thirty-nine percent of the patients presented perianal disease at diagnosis (n = 29). We documented 70.3% clinical and 47.2% endoscopic remissions. Several variables had statistical significance toward the outcomes (endoscopic and clinical remissions) in the univariate analysis. After adjusting for confoundment, patients with perianal disease presented an odds ratio (OR) of 0.201 for achieving endoscopic remission (CI: 0.054-0.75, p value 0.017) and an OR of 0.203 for achieving clinical remission (CI: 0.048-0.862, p value 0.031). Sixty-six patients (89.2%) presented an initial response to treatment, from whom, 20 (30.3%) exhibited at least 1 disease relapse (clinical and/or endoscopic). Patients with perianal disease presented higher probability of disease relapse, displaying statistically significant difference on Kaplan-Meier curves (Breslow p value 0.043)., Conclusion: In the first year of combination therapy, perianal disease is associated with an 80% decrease in endoscopic and clinical remission rates and higher ratio of disease relapse., (© 2020 S. Karger AG, Basel.)

Background: Small bowel capsule endoscopy (SBCE) is the gold standard for suspected small bowel bleeding (SBB). Angioectasias are the most common vascular anomalies in the gastrointestinal tract and have been reported as the source of SBB in up to 80% of patients. Considering their frequency, their usual intermittent bleeding nature, and their risk of rebleeding, the aim of this study was to identify some features and possible predictors of rebleeding in the presence of these lesions., Methods: This is a retrospective study, which included consecutive SBCE with angioectasias between April 2008 and December 2017 with a minimum follow-up of 12 months. Rebleeding was defined as a drop of hemoglobin ≥ 2 g/dl and/or in the presence of hematochezia or melenas with negative esophagogastroduodenoscopy and ileocolonoscopy. Data were collected from medical records, and angioectasias were classified by number, location, size, and type. Univariate and multivariable statistical analysis was performed to identify possible predictors of rebleeding., Results: From a total of 630 patients submitted to SBCE for suspected SBB, 129 with angioectasias were included; 59.7% were female, with a median age of 72 (19-91) years old and a mean follow-up of 44.0 ± 31.9 months. In 32.6% (n = 42) of the patients, at least one episode of rebleeding was documented. The presence of heart failure (OR 3.41; IC95% 1.18-9.89; p = 0.024), the size of the angioectasias (OR 5.41; IC95% 2.15-13.6; p < 0.001), and smoking status (OR 3.15; IC95% 1.07-9.27; p = 0.038) were independent predictor factors of rebleeding., Conclusion: Heart failure, smoking status, and angioectasias with a size superior to 5 mm are independent predictor factors of rebleeding in a population with angioectasias diagnosed by SBCE.

Background: The use of combination therapy of anti-TNFα and thiopurines in inflammatory bowel disease (IBD) is associated with greater efficacy and lower immunogenicity. However, the dose of thiopurine in this setting remains to be elucidated., Aim: To compare the trough levels, anti-TNFα antibodies and the inflammatory biomarkers between three groups in combotherapy: group 1 (dose of azathioprine <1 mg/kg); group 2 (dose of azathioprine ≥1 and <2 mg/kg), and group 3 (dose of azathioprine ≥2 mg/kg)., Methods: A retrospective study was performed, selecting all patients with established diagnosis of IBD who were on combined maintenance treatment., Results: We included 99 patients, 52.5% female with median age 33 (17-61) years. Eighty patients (80.8%) were diagnosed with Crohn's disease and 19 (19.2%) with ulcerative colitis. Seventy-one (71.8%) patients were on infliximab (IFX) and 28 (28.3%) were on adalimumab (ADA). In patients treated with IFX, there were no differences in trough levels ( p =.976) or formation of antibodies anti-IFX ( p =.478) between groups. Moreover, there were no differences in inflammatory biomarkers: CRP ( p =.385) and fecal calprotectin ( p =.576) among the three groups. Regarding patients treated with ADA, there were no differences in trough levels of ADA ( p =.249), formation of antibodies anti-ADA ( p =.706) or in inflammatory biomarkers: CRP ( p =.738) and fecal calprotectin ( p =.269) among the three groups., Conclusion: In our cohort, there were no differences between anti-TNFα trough levels, formation of anti-TNFα antibodies or inflammatory biomarkers among patients in combotherapy with azathioprine, irrespective of its dosage. In conclusion, our study suggests that maintaining therapeutic levels of anti-TNFα drugs without antibodies formation is feasible with lower doses of azathioprine, minimizing its side effects.

Background and Aims: The histological status of ulcerative colitis [UC] patients in clinical and endoscopic remission has gained space as an important prognostic marker and a key component of disease monitoring. Our main aims were to compare two histological indexes-the continuous Geboes score [GS] and the Robarts Histopathology index [RHI]-regarding their definitions of histological remission and response, and the ability of faecal calprotectin [FC] levels to discriminate between these statuses., Methods: This was an analysis of three prospective cohorts including 422 patients previously enrolled in other studies., Results: The two continuous scores [GS and RHI] were shown to be significantly correlated [correlation coefficient of 0.806, p < 0.001] and particularly close regarding their definition of histological response: 95% and 88% of all patients classified as having/not having [respectively] histological response according to RHI also did so according to GS. Moreover, median FC levels in patients with histological response were lower than those in patients without histological response [GS: 73.00 vs 525.00, p < 0.001; RHI: 73.50 vs 510.00, p < 0.001]; a similar trend was observed when FC levels of patients in histological remission were compared to those of patients with histological activity [GS: 76.00 vs 228.00, p < 0.001; RHI: 73.50 vs 467.00, p < 0.001]. FC levels allowed us to exclude the absence of histological remission [according to RHI] and absence of histological response [according to RHI and GS], with negative predictive values varying from 82% to 96%. However, optimization of the FC cut-off to exclude the absence of histological remission, as for the continuous GS, falls within values that resemble those of the healthy population., Conclusion: The continuous GS and RHI histological scores are strongly correlated in their definitions of histological response. An absence of histological remission could only be excluded at physiological levels of FC., (Copyright © 2019 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Small bowel capsule endoscopy (SBCE) is the reference standard tool for diagnosing small bowel bleeding (SBB). The "TOP 100", which performs an automatic selection of the 100 images that mostly likely contain abnormalities, emerged as a new functionality of the RAPID Reader® software in 2017., Aim: To compare the concordance of findings between the standard reading (SR) and the use of TOP 100 in suspected SBB., Methods: Retrospective study, including consecutive patients submitted to SBCE for suspected SBB. Two experienced readers performed SR and reported the most important findings. Another experienced reader, who was blinded to the SR results, reviewed all the SBCE videos using TOP 100 and reported the most important findings. The relevant findings were defined as the presence of high bleeding potential lesions (P2)., Results: 97 patients were included. The TOP 100 detected 81/97(83.5%) of the P2 lesions, in particular 64/67(95.5%) of the angioectasias and 17/30(56.7%) of the ulcers. The TOP 100 identified all sites of active bleeding (n = 9)., Conclusion: The TOP 100 identified all sites of active bleeding, as well as the vast majority of significant lesions (83.5%); in particular, it detected over 95% of the angioectasias. Although SR remains the reference standard in the SBCE review, these findings demonstrate that TOP 100 allows for a quick preview reading constituting an important asset in the identification of lesions that may require priority full review and intervention planning., (Copyright © 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Mantle cell lymphoma (MCL) of the colon is a rare entity, usually presenting as lymphomatous polyposis. We report the case of a 43-year-old male with an unusual colonic MCL in the form of a single exophytic and ulcerous lesion with necrotic areas associated with an ileo-cecal intussusception. The endoscopic appearance suggested adenocarcinoma. However, the diagnosis was made by histology and immunohistochemistry studies of the endoscopic biopsies.

Background: Pan-intestinal capsule endoscopy (Pan-CE) has been used to assess both the small and large bowel inflammation in Crohn's disease (CD) patients in a single examination. The capsule endoscopy Crohn's disease activity index (CECDAI) was initially developed to measure mucosal disease activity in the small bowel, although in 2018, it was extended to the colon for standardization of inflammatory activity (CECDAIic). The aim of this study was to apply the CECDAIic in a cohort of CD patients that underwent Pan-CE to evaluate the inter-observer agreement and the correlation between this score and inflammatory parameters. Methods: The videos were read and scored using the CECDAIic by three independent experienced operators, blinded to the results of the standard workup. Statistical analysis was performed with SPSS ® , using Kendall's coefficient to evaluate the inter-observer agreement. Spearman correlation ( r s ) was used to access the correlation between the score and inflammatory biomarkers. Results: Included 22 patients, 59.1% males with mean age of 30.7 ± 11.1 years. The median CECDAIic score was 9.17 (0-37). The overall CECDAIic score Kendall coefficient was 0.94, demonstrating a statistically significant ( p  < .001) and excellent agreement between the three observers. In addition, we found a very good correlation between CECDAIic and calprotectin ( r s  = 0.82; p  = .012) and a moderate correlation with C-reactive protein (CRP, r s  = 0.50; p  = .019). Conclusions: CECDAIic is a new score with excellent inter-observer agreement and strong correlation with calprotectin levels.

Background: Bariatric surgery (BS) is one of the most effective approaches to weight loss. Performing esophagogastroduodenoscopy (EGD) prior to BS is controversial but allows the detection and treatment of mucosal lesions that may affect surgical decision and type of surgery., Aim: The aim of this study was to identify the frequency of gastric lesions and Helicobacter pylori (Hp) infection in a group of asymptomatic patients on the waiting list for BS., Methods: This is a retrospective descriptive study including patients undergoing EGD before BS., Results: A total of 360 patients were included with a mean age of 42.1 ± 10.8 years, 319 (88.6%) were females, with a mean body mass index of 42.8 ± 5.44 kg/m 2 . Regarding endoscopic findings, 25.6% presented no endoscopic lesions, 61.6% presented hyperemic gastropathy, 11.4% erosive gastropathy, 1.1% gastric polyp, and 0.3% gastric ulcer. Histologically, no changes were observed in 20.8% of the patients, 239 (66.4%) presented with superficial gastritis, 11.7% ( n = 42) had chronic atrophic gastritis and intestinal metaplasia ( n = 34 in the antrum, n = 1 in the body, and n = 7 in both the antrum and the body), and 1.7% ( n = 6) had low-grade dysplasia. Hp was positive in 251 (69.7%) patients. We found that patients with metaplasia or dysplasia were more frequently submitted to surgical techniques that did not exclude the stomach (55.8 vs. 16.4%, p < 0.001)., Conclusion: EGD with histological analysis plays an important role in the pre-surgical evaluation in BS, with a high rate of pathological findings in asymptomatic patients. These findings may have an impact on the long-term management and outcomes of these patients., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2019 by S. Karger AG, Basel.)

Background: Obesity is one of the main factors of transient elastography (TE) failure, considering body mass index (BMI) ≥28 kg/m 2 as a limiting factor. The XL probe was designed to overcome this limitation. Aim: To compare the feasibility of the M and XL probes in patients with BMI ≥ 28 kg/m 2 , to evaluate differences in mean values of controlled attenuation parameter (CAP) and liver stiffness measurement (LSM) between the two probes and find predictive factors of TE failure. Material and methods: Prospective study, including all patients with BMI ≥ 28 kg/m 2 consecutively admitted for TE. Results: Included 161 patients. Measurements with M probe were reliable in 69.6% of the patients, with 68.2% of valid measurements in obese population and 58.9% in patients with skin-capsule distance (SCD) >25 mm. In 40 patients (81.6%) with an invalid M probe measurement, a reliable result was obtained with XL probe. We found that SCD >25 mm was the only predictor of M probe failure (OR: 4.9, CI: 1.64-14.63, p  = .004). In those patients in which TE was possible with both probes ( n  = 112), mean CAP was 304 ± 49 dB/m 2 with M probe and 301 ± 50 dB/m 2 with XL probe ( p  = .59). Regarding liver stiffness, a mean value of 7.58 ± 3.47 kpas was obtained with the M probe and 6.21 ± 3.44 kpas with the XL probe ( p  < .001). Conclusion: There is a reliable applicability of the M probe in a high number (68.2%) of patients with a BMI ≥30 kg/m 2 . A SCD >25 mm was the only predictive factor of M probe failure. Mean values of LSM with XL probe were lower than those obtained with M probe.

Background: Recent studies suggest an increased prevalence of hepatic steatosis (HS) in patients with inflammatory bowel disease (IBD). Features such as chronic inflammation, previous surgeries, drug-induced hepatotoxicity, malnutrition, and intestinal dysbiosis seem to be involved in its pathogenesis., Aims: The aim of this study was to assess the frequency of HS in patients with IBD quantified by controlled attenuation parameter (CAP) and by clinical-analytical scores: Hepatic Steatosis Index (HSI) and Fatty Liver Index (FLI). The secondary aim was to investigate risk factors associated with HS in patients with IBD., Patients and Methods: A cross-sectional study was carried out including consecutive outpatients observed in our department between January and March 2017. HS was defined as HSI of at least 36 or FLI of at least 60 or CAP of greater than 248., Results: A total of 161 patients were included, with a mean age of 40.6±12.8 years. There were 86 (53.4%) female patients. Overall, 62.7% had Crohn's disease and 37.1% had ulcerative colitis. Moreover, 73 (45.3%) patients had CAP greater than 248, 27 (16.8%) had FLI greater than 60, and 46 (28.6%) had HSI greater than 36.We found that patients with CAP of greater than 248 were more frequently obese (28.8 vs. 0.0% P<0.001), male (57.5 vs. 37.5% P=0.011), and presented more frequently with metabolic syndrome (23.9 vs. 4.5% P <0.001). With regard to IBD factors, patients with HS had a higher frequency of previous surgeries (31.5 vs. 12.5% P=0.003). In multivariate analysis, only male sex [odds ratio: 5.7 (95% confidence interval: 2.0-15.9); P=0.001] and previous surgeries [odds ratio: 5.9 (95% confidence interval: 1.5-22.9); P=0.011] were independent risk factors of HS., Conclusion: In our cohort, the frequency of HS varied between 16.8 and 45.3% defined by noninvasive methods. We found that male sex and previous history of surgery were the independent risk factors of HS when quantified by transient elastography.

Background and Aim: Fecal calprotectin (FC) is a noninvasive marker of intestinal inflammation. Predicting relapses in Crohn's disease (CD) patients can allow earlier changes in therapy. The aim of this study was to evaluate the role of FC in predicting relapse in CD patients in clinical remission within six months follow-up., Methods: Patients with CD who were in clinical remission at least ≥3 months were included in this study. The first FC sample during the remission period was evaluated and was used as the baseline value. Relapse was defined as an unexpected escalation in therapy, hospitalization or need for surgery for active CD. The accuracy and optimal cutoff FC values for predicting clinical relapse at six months were assessed by the area under the ROC curve (AUC)., Results: One hundred and forty-four patients were evaluated, with mean age of 38.4 years. Of these, 13 (9%) had a relapse during the follow-up period. The mean FC value was significantly lower for non-relapsers (203.2 μg/g) than for relapsers (871.3 μg/g), p < .001. The AUC for predicting relapse by using FC values was 0.924. The optimal cutoff FC value to predict relapse was 327 μg/g; with values of sensitivity, specificity, negative predictive value and positive predictive value were 92.3%, 82.4%, 99.1% and 34.3%, respectively., Conclusions: FC is more useful in predicting remission maintenance than relapse in patients with CD in clinical remission. Values of FC ≤327 μg/g can exclude relapse at least at six months follow-up period.

Common variable immunodeficiency (CVID) is the most frequent form of immunodeficiency in adults. Clinical manifestations are heterogeneous with an increased susceptibility to infections and inflammatory conditions, namely autoimmune diseases, such as inflammatory bowel disease. We present the clinical case of a Caucasian female patient, 21 years old, with a past medical history of CVID, with multiple visits to the emergency department due to abdominal pain in the lower quadrants and diarrhea. Her biochemical analysis showed elevated inflammatory parameters. Stool cultures and parasitological examination of feces were negative. Ileocolonoscopy revealed lymphoid nodular hyperplasia of the terminal ileum, and the small bowel capsule endoscopy demonstrated edema and multiple pleomorphic ulcers (Lewis score = 1,104). CVID-associated inflammatory enteropathy was suspected. Budesonide 9 mg/day was started, but no positive clinical response was observed. It was decided to initiate biological therapy with infliximab. The patient's condition is currently clinically improved with no complications due to biological therapy.

Background: Crohn's disease (CD) is a chronic and progressive disease that changes its behaviour over time. Transmural inflammation in CD leads to stricturing and/or penetrating complications., Aim: To evaluate the frequency of long-term progression of CD phenotypes, the need of abdominal surgery, and the main factors associated with these outcomes., Methods: A retrospective study was conducted with a prospective follow-up. Montreal classification was assessed at the moment of the diagnosis and at the end of the follow-up period., Results: Two hundred and ninety patients were included, with mean follow-up duration of nine years. A change in behaviour was observed in 46 patients (15.9%). Ileocolic location (60.9% vs. 45.1%; p = .049), age at diagnosis <16 years (8.7% vs. 2.0%; p = .017), the use of steroids at diagnosis (43.2% vs. 27.0%; p = .031) and shorter exposure time to biological therapy (15.9 months vs 41.3 months; p < .001) were identified as risk factors for phenotype change. Regarding surgery, 70 patients (24.1%) were submitted to abdominal surgery. Smoking habits (41.3% vs. 26.9%; p = .048), stricturing behaviour (50% vs. 18.4%; p < .001), penetrating behaviour 34.8% vs. 7.8%; p < .001), hospitalisations in the first year of diagnosis (52.3% vs. 12.4%; p < .001), and use of steroids at diagnosis (61.4% vs. 23.6%; p < .001) were more frequently seen in patients subjected to surgery. Patients subjected to surgery were less frequently treated with biological therapy (8.7% vs. 23.4%; p < .025)., Conclusions: A behaviour progression was observed in about one-sixth of the patients. Progression to a stricturing pattern was the most frequent change in behaviour. Stricturing and penetrating behaviour, higher number of hospitalisations in the first year of diagnosis, use of steroids at diagnosis, smoking status, age at diagnosis <16 years and ileocolic disease location were associated with an unfavourable clinical evolution.

Objectives: Perianal Crohn's disease (CD) prevalence varies according to the disease location, being particularly frequent in patients with colonic involvement. We aimed to evaluate small bowel involvement and compare small bowel capsule endoscopy findings and inflammatory activity between patients with and without perianal disease., Materials and Methods: Retrospective single-center study including 71 patients - all patients with perianal CD (17 patients) who performed a small bowel capsule endoscopy were included, and non-perianal CD patients were randomly selected (54 patients). Clinical and analytical variables at diagnosis were reviewed. Statistical analysis was performed with SPSS v21.0 and a two-tailed p value <.05 was defined as indicating statistical significance., Results: Patients had a median age of 30 ± 16 years with 52.1% females. Perianal disease was present in 23.9%. Patients with perianal disease had significantly more relevant findings (94.1% vs 66.6%, p = .03) and erosions (70.6% vs 42.6%, p = .04), however, no differences were found between the two groups regarding ulcer, villous edema and stenosis detection. Overall, patients with perianal disease had more frequently significant small bowel inflammatory activity, defined as a Lewis Score ≥135 (94.1% vs 64.8%, p = .03), and higher Lewis scores in the first and second tertiles (450 ± 1129 vs 0 ± 169, p = .02 and 675 ± 1941 vs 0 ± 478, p = .04, respectively). No differences were found between the two groups regarding third tertile inflammatory activity assessed with the Lewis Score., Conclusion: Patients with perianal CD have significantly higher inflammatory activity in the small bowel, particularly in proximal small bowel segments, when compared with patients without perianal disease.

Background: Small bowel capsule endoscopy (SBCE) is a very important tool in the diagnosis and monitoring of Crohn's disease (CD). The Lewis score (LS) and Capsule Endoscopy Crohn's Disease Activity Index (CECDAI) are used to quantify and standardize inflammatory activity observed in the SBCE., Aim: To evaluate the correlation between the LS and CECDAI scores and inflammation biomarkers (C-reactive protein [CRP] and erythrocyte sedimentation rate [ESR]). A secondary goal was to define thresholds for CECDAI based on thresholds already established for LS., Methods: This was a retrospective study of 110 patients with suspect or known CD, with involvement of small bowel. Linear regression was used to calculate thresholds of CECDAI corresponding to the thresholds already established for LS. A Pearson correlation (r) was used to calculate the correlation between the LS and CECDAI scores and biomarker levels. Only patients with exclusive involvement of the small bowel were selected (n = 78)., Results: A moderate correlation was found between the endoscopic scores (r = 0.59, p < 0.001). CECDAI scores of 5.57 and 7.53 corresponded to scores of 135 and 790 in LS, respectively. There was a statistically significant correlation between CRP and the LS (r = 0.28, p = 0.014) and CECDAI (r = 0.29, p = 0.009). There was also a significant correlation between ESR and CECDAI (r = 0.29, p = 0.019), but not with LS., Conclusion: There is a moderate correlation between the two scores. This study allowed the calculation of thresholds for CECDAI based on those defined for LS. We found a weak correlation between SBCE endoscopic activity and inflammatory biomarkers.

Objectives: The real benefit of gastrostomy is still a matter of debate. We aimed to prospectively evaluate the global impact of percutaneous endoscopic gastrostomy (PEG) in patients followed at a specialized multidisciplinary clinic, namely, the impact on the need for healthcare resources, anthropometric measures, pressure ulcers prevention and healing, and nutritional and hydration status., Patients and Methods: From the 201 patients who underwent PEG between May 2011 and September 2014, 60 were included in a prospective study. Anthropometric, clinical, and laboratorial variables were collected and compared before and after PEG. Follow-up duration, mortality, and number of emergency department visits or hospital admissions were also assessed., Results: Thirty-three (55.0%) patients were women and the median age was 79 years. The main indications for PEG were dementia (43.3%) and poststroke dysphagia (30.0%). Four months following PEG, significant decreases in the tricipital skinfold (P=0.002) and brachial perimeter (P=0.003) were found. A decrease in the mean number of hospitalizations (1.4 vs. 0.3; P<0.001) and visits to emergency department (2.2 vs. 1.1; P=0.003) was noted in the next 6 months after PEG compared with the previous semester. In 53.8% of patients with pressure ulcers, complete healing was observed after PEG. PEG was associated with increases in hemoglobin (P=0.024), lymphocytes (P=0.041), cholesterol (P=0.008), transferrin (P<0.001), albumin (P<0.001), and total proteins (P<0.001), and a decrease in serum sodium (P=0.001)., Conclusion: Anthropometric values may not translate the early benefits of a gastrostomy. PEG decreases the need for hospital health care, facilitates healing of pressure ulcers, and induces biochemical changes that may reflect better nutrition and hydration.

Background and Aims: Mucosal healing and histological remission are different targets for patients with ulcerative colitis, but both rely on an invasive endoscopic procedure. This study aimed to assess faecal calprotectin and neutrophil gelatinase B-associated lipocalin as biomarkers for disease activity in asymptomatic ulcerative colitis patients., Methods: This was a multicentric cross-sectional study including 371 patients, who were classified according to their endoscopic and histological scores. These results were evaluated alongside the faecal levels of both biomarkers., Results: Macroscopic lesions [i.e. endoscopic Mayo score ≥1] were present in 28% of the patients, and 9% had active disease according to fht Ulcerative Colitis Endoscopic Index of Severity. Moreover, 21% presented with histological inflammation according to the Geboes index, whereas 15% and 5% presented with focal and diffuse basal plasmacytosis, respectively. The faecal levels of calprotectin and neutrophil gelatinase B-associated lipocalin were statistically higher for patients with endoscopic lesions and histological activity. A receiver operating characteristic-based analysis revealed that both biomarkers were able to indicate mucosal healing and histological remission with an acceptable probability, and cut-off levels of 150-250 μg/g for faecal calprotectin and 12 μg/g for neutrophil gelatinase B-associated lipocalin were proposed., Conclusions: Faecal calprotectin and neutrophil gelatinase B-associated lipocalin levels are a valuable addition for assessment of disease activity in asymptomatic ulcerative colitis patients. Biological levels of the analysed biomarkers below the proposed thresholds can rule out the presence of macroscopic and microscopic lesions with a probability of 75-93%. However, caution should be applied whenever interpreting positive results, as these biomarkers present consistently low positive predictive values., (Copyright © 2016 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com)

Introduction: Helicobacter pylori eradication has become increasingly difficult as resistances to several antibiotics develop. We aimed to compare Helicobacter pylori eradication rates between triple therapy and sequential therapy in a naive Portuguese population., Material and Methods: Prospective randomized trial including consecutive patients referred for first-line Helicobacter pylori eradication treatment., Exclusion Criteria: previous gastric surgery/neoplasia, pregnancy/lactancy, allergy to any of the drugs. The compared eradication regimens were triple therapy (pantoprazol, amoxicillin and clarithromycin 12/12 hours, 14 days) and sequential therapy (pantoprazol 12/12 hours for 10 days, amoxicillin 12/12 hours for days 1 - 5 and clarithromycin plus metronidazol 12/12 hours during days 6 - 10). Eradication success was confirmed with urea breath test. Statistical analysis was performed with SPSS v21.0 and a p-value < 0.05 was considered statistically significant., Results: Included 60 patients, 39 (65%) female with mean age 52 years (SD ± 14.3). Treatment groups were homogeneous for gender, age, indication for treatment and smoking status. No statistical differences were encountered between sequential and triple therapy eradication rates (86.2% vs 77.4%, p = 0.379), global eradication rate was 82%. Tobacco consumption was associated with a significantly lower eradication success (54.5 vs 87.8%, p = 0.022)., Discussion: In this randomized controlled trial in a naive Portuguese population, we found a satisfactory global Helicobacter pylori eradication rate of 82%, with no statistical differences observed in the efficacy of the treatment between triple and sequential regimens., Conclusion: These results support the use of either therapy for the first-line eradication of Helicobacter pylori.

Aim: To evaluate the role of small bowel capsule endoscopy (SBCE) on the reclassification of colonic inflammatory bowel disease type unclassified (IBDU)., Methods: We performed a multicenter, retrospective study including patients with IBDU undergoing SBCE, between 2002 and 2014. SBCE studies were reviewed and the inflammatory activity was evaluated by determining the Lewis score (LS). Inflammatory activity was considered significant and consistent with Crohn's disease (CD) when the LS ≥ 135. The definitive diagnosis during follow-up (minimum 12 mo following SBCE) was based on the combination of clinical, analytical, imaging, endoscopic and histological elements., Results: Thirty-six patients were included, 21 females (58%) with mean age at diagnosis of 33 ± 13 (15-64) years. The mean follow-up time after the SBCE was 52 ± 41 (12-156) mo. The SBCE revealed findings consistent with significant inflammatory activity in the small bowel (LS ≥ 135) in 9 patients (25%); in all of them the diagnosis of CD was confirmed during follow-up. In 27 patients (75%), the SBCE revealed no significant inflammatory activity (LS < 135); among these patients, the diagnosis of Ulcerative Colitis (UC) was established in 16 cases (59.3%), CD in 1 case (3.7%) and 10 patients (37%) maintained a diagnosis of IBDU during follow-up. A LS ≥ 135 at SBCE had a sensitivity = 90%, specificity = 100%, positive predictive value = 100% and negative predictive value = 94% for the diagnosis of CD., Conclusion: SBCE proved to be fundamental in the reclassification of patients with IBDU. Absence of significant inflammatory activity in the small intestine allowed exclusion of CD in 94% of cases., Competing Interests: Conflict-of-interest statement: The authors declare that there is no conflict of interests regarding the publication of this paper.

Background: Small bowel bleeding is a leading indication for small bowel capsule endoscopy. The Suspected Blood Indicator (SBI) is a software feature directed to automatically detect bleeding lesions during small bowel capsule endoscopy., Objective: - We aimed to assess SBI diagnostic accuracy for small bowel haemorrhage or potentially bleeding lesions during small bowel capsule endoscopy for small bowel bleeding. Methods - Single-centre retrospective study including 281 consecutive small bowel capsule endoscopy performed for small bowel bleeding during 6 years. The investigators marked lesions with high bleeding potential (P2), such as angioectasias, ulcers and tumours, as well as active bleeding during regular small bowel capsule endoscopy viewing with PillCam SB2(r). All small bowel capsule endoscopy were independently reviewed by another central reader using SBI., Results: - Among the 281 patients, 29 (10.3%) presented with active haemorrhage while 81 (28.9%) presented with a P2 lesion. The most frequently observed P2 lesions were angioectasias (52), ulcers (15), polyps (7) and ulcerated neoplasias (7). SBI showed a 96.6% (28/29) sensitivity for active small bowel bleeding, with a 97.7% negative predictive value. Regarding P2 lesions, the SBI displayed an overall sensitivity of 39.5%, being highest for ulcerated neoplasias (100%), but significantly lower for angioectasias (38.5%) or ulcers (20.0%)., Conclusion: Although SBI sensitivity for the automatic detection of potentially bleeding lesions was low, it effectively detected active small bowel bleeding with very high sensitivity and negative predictive value.

Introduction: The identification of subepithelial lesions is a relatively frequent finding at endoscopy however their natural history is not well known. Our aim was to analyze the role of endoscopic ultrasound (EUS) in the diagnostic approach of subepithelial lesions of the upper gastrointestinal tract., Methods: Retrospective study which included 324 patients undergoing upper radial EUS for evaluation of subepithelial lesions from 2008 to 2014. The EUS features, presumptive diagnosis and management decision were analyzed., Results: 324 patients included, 60% with gastric subepithelial lesions, 28% oesophageal and 12% from the duodenum. Based on EUS features the presumptive diagnosis was: 25% gastrointestinal stromal tumor, 21% lipoma, 19% leiomyoma, 17% pancreatic rest, 7% submucosa cysts, 1% granular cell tumors, 1% carcinoids, 1% mucosa lesions and 8% not defined. After EUS the suggested approach was no follow-up in 45%, follow-up with re-examination with EUS in 35% and additional tissue sampling or endoscopic/surgical resection in 20%. The latter was based on EUS features of risk at the diagnosis (53%), such as size ≥2 cm, hypoechogenicity, heterogeneity, lobulation, calcifications, cystic component and regional adenopathies; impossibility to define a presumptive diagnosis (39%) or EUS features change at follow-up (8%). The combination of multiple features correlated with a higher probability of this recommended strategy ( p  < 0.001), in 100% when 4 or more features were present. Among the 33 patients who underwent fine needle aspiration, in 66% the result was inconclusive. During follow-up, none of the patients who were managed with surveillance radial EUS presented complications., Conclusion: EUS is the method of choice in the study of subepithelial lesions of the upper gastrointestinal tract, in most cases defining a diagnosis. The need for a definitive diagnosis or therapeutic approaches can be based on ultrasound risk features, presented, in the majority, at presentation. This study shows that EUS is capable of safely and accurately define those subepithelial lesions that can be managed only with surveillance ultrasound while waiting for better results with fine needle aspiration.

Background: Small bowel capsule endoscopy represents the initial investigation for obscure gastrointestinal bleeding. Flexible spectral imaging colour enhancement (FICE) is a virtual chromoendoscopy technique designed to enhance mucosal lesions, available in different settings according to light wavelength-- FICE1, 2 and 3., Aims: To compare the diagnostic yield of FICE1 and white light during capsule endoscopy in patients with obscure gastrointestinal bleeding., Methods: Retrospective single-centre study including 60 consecutive patients referred for small bowel capsule endoscopy for obscure gastrointestinal bleeding. Endoscopies were independently reviewed in FICE1 and white light; findings were then reviewed by another researcher, establishing a gold standard. Diagnostic yield was defined as the presence of lesions with high bleeding potential (P2) angioectasias, ulcers or tumours., Results: Diagnostic yield using FICE1 was significantly higher than white light (55% vs. 42%, p=0.021). A superior number of P2 lesions was detected with FICE1 (74 vs. 44, p=0.003), particularly angioectasias (54 vs. 26, p=0.002), but not ulcers or tumours., Conclusions: FICE1 was significantly superior to white light, resulting in a 13% improvement in diagnostic yield, and potentially bleeding lesions particularly angioectasias were more often observed. Our results support the use of FICE1 while reviewing small bowel capsule endoscopy for obscure gastrointestinal bleeding., (Copyright © 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background and Aims: Extensive evidence has underlined the importance of mucosal healing as a treatment aim for ulcerative colitis (UC). We aimed to assess differences in the incidence of clinical relapse at 12 months between UC patients with Mayo endoscopic scores (MES) 0 and 1., Methods: This retrospective study included consecutive patients in corticosteroid-free remission between 2008 and 2013 and with follow-up of at least 1 year, with MES 0 or 1 in complete colonoscopy. Clinical relapse was defined as need for induction treatment, treatment escalation, hospitalization or surgery. A p value <0.05 was considered statistically significant., Results: The study included 138 patients, 72 (52.2%) female, with mean age of 49 (±14) years. Inflammatory activity was classified as MES 0 in 61 (44.2%) patients and MES 1 in 77 (55.8%) patients. Clinical relapse during follow-up was significantly more frequent in patients with MES 1 than MES 0 (27.3 vs 11.5%, p = 0.022), and in the multivariate analysis MES 1 was the only factor significantly associated with an increased risk of relapse (odds ratio 2.89, 95% confidence interval 1.14-7.36, p = 0.026). This association was encountered in the subgroup of patients with left-sided/extensive colitis (29.7 vs 11.1%, p = 0.049), but not proctitis (25.0 vs 12.0%, p = 0.202)., Conclusions: In patients with UC in corticosteroid-free remission, particularly those with left-sided colitis or extensive colitis, MES 1 was significantly associated with a 3-fold increased risk of relapse compared with endoscopic MES 0. Our results support the use of endoscopic MES 0 as the most suitable treatment endpoint to define mucosal healing in patients with UC., (Copyright © 2015 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background and Aims: Small bowel capsule endoscopy (SBCE) allows mapping of small bowel inflammation in Crohn's disease (CD). We aimed to assess the prognostic value of the severity of inflammatory lesions, quantified by the Lewis score (LS), in patients with isolated small bowel CD., Methods: A retrospective study was performed in which 53 patients with isolated small bowel CD were submitted to SBCE at the time of diagnosis. The Lewis score was calculated and patients had at least 12 months of follow-up after diagnosis. As adverse events we defined disease flare requiring systemic corticosteroid therapy, hospitalization and/or surgery during follow-up. We compared the incidence of adverse events in 2 patient subgroups, i.e. those with moderate or severe inflammatory activity (LS ≥790) and those with mild inflammatory activity (135 ≤ LS < 790)., Results: The LS was ≥790 in 22 patients (41.5%), while 58.5% presented with LS between 135 and 790. Patients with a higher LS were more frequently smokers (p = 0.01), males (p = 0017) and under immunosuppressive therapy (p = 0.004). In multivariate analysis, moderate to severe disease at SBCE was independently associated with corticosteroid therapy during follow-up, with a relative risk (RR) of 5 (p = 0.011; 95% confidence interval [CI] 1.5-17.8), and for hospitalization, with an RR of 13.7 (p = 0 .028; 95% CI 1.3-141.9)., Conclusion: In patients with moderate to severe inflammatory activity there were higher prevalences of corticosteroid therapy demand and hospitalization during follow-up. Thus, stratifying the degree of small bowel inflammatory activity with SBCE and LS calculation at the time of diagnosis provided relevant prognostic value in patients with isolated small bowel CD., (Copyright © 2015 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: The Lewis Score (LS) aims to standardize the method of quantification of small bowel inflammatory activity detected by the small bowel capsule endoscopy (SBCE). The aim of this study was to evaluate the diagnostic accuracy of the LS in patients with suspected CD undergoing SBCE., Methods: We performed a retrospective study including patients who underwent SBCE for suspected CD between September 2006 and February 2013. Patients were grouped according to the criteria of the International Conference on Capsule Endoscopy for the definition of suspected CD. Inflammatory activity on SBCE was objectively assessed by determining the LS., Results: Ninety-five patients were included. Group 1: 37 patients not fulfilling International Conference on Capsule Endoscopy criteria; Group 2: 58 patients with ≥ 2 International Conference on Capsule Endoscopy criteria. The diagnosis of CD was established in 38 patients (40%): 8 (21.6%) from group 1 and 30 from group 2 (51.7%) (P = 0.003). Among those patients, 34 had LS ≥ 135 (73.9%) and 4 had LS <135 (8.2%) at SBCE (P < 0.001). The LS ≥ 135 had an overall diagnostic accuracy of 83.2% with a sensitivity, specificity, positive predictive value, and negative predictive value for the diagnosis of CD of 89.5%, 78.9%, 73.9%, and 91.8%, respectively., Conclusions: The application of LS ≥ 135 as the cutoff value for the presence of significant inflammatory activity in patients undergoing SBCE for suspected CD may be useful to establish the diagnosis of CD. In patients with LS < 135, the probability of having CD confirmed on follow-up is low.

Background: Ulcerative colitis (UC) has a recognized phenotypic heterogeneity. Some studies suggest that age at diagnosis may influence features and natural history of the disease., Aim: This study aimed to compare patients', disease's and treatment's features between Portuguese patients diagnosed before and after the age of 40-years-old., Methods: Retrospective single-center study that included 310 patients with UC, divided in two groups: Those diagnosed before the age of 40-years-old (early onset UC) and those diagnosed later than that (late onset UC). In each group features of the patients (gender, family history, smoking), of the disease (duration, extension, severity, clinical course, hospitalization, extraintestinal manifestations), and of treatment (oral aminosalicylates, systemic steroids or immunomodulators) were analyzed. Statistical analysis was performed using SPSSv22.0. Univariate and multivariate analyses were performed to assess factors associated with early and late onset UC., Results: From the analyzed patients, 207 had UC diagnosed before the age of 40 years old (43.5% men; mean age at diagnosis 29.4 ± 6.9 years) and 103 were diagnosed after that age (61.2% men; mean age at diagnosis 51.8 ± 8.1 years). In the group diagnosed before 40 years old, female gender (p = 0.003), severe disease (p = 0.002), chronic intermittent clinical course (p = 0.026), and hospitalizations (p = 0.001) were significantly more frequent. The use of oral aminosalicylates (p = 0.032), systemic steroids (p = 0.003) and immunomodulators (p = 0.012) were also more common in the early onset UC group. No differences between groups were found in family history, smoking, disease's extension, extraintestinal manifestations, and use of biological agents. Multivariate analysis pointed early onset UC to be significantly associated with female gender (odds ratio [OR], 1.77; 95% confidence interval [CI], 1.08-2.91; p = 0.024), chronic intermittent symptoms (OR, 2.34; 95% CI, 1.17-4.70; p = 0.016), and need of hospitalization (OR, 2.89; 95% CI, 1.46-5.72; p = 0.002)., Conclusions: When diagnosed before the age of 40-years-old, UC preferably affects women and manifests as a more severe disease, with more frequent hospitalizations and chronic intermittent symptoms. These facts might have implications in planning timely and individualized future therapeutic strategies.

Aim: To evaluate mucosal healing in patients with small bowel plus colonic Crohn's disease (CD) with a single non-invasive examination, by using PillCam COLON 2 (PCC2)., Methods: Patients with non-stricturing nonpenetrating small bowel plus colonic CD in sustained corticosteroid-free remission were included. At diagnosis, patients had undergone ileocolonoscopy to identify active CD lesions, such as ulcers and erosions, and small bowel capsule endoscopy to assess the Lewis Score (LS). After ≥ 1 year of follow-up, patients underwent entire gastrointestinal tract evaluation with PCC2. The primary endpoint was assessment of CD mucosal healing, defined as no active colonic CD lesions and LS < 135., Results: Twelve patients were included (7 male; mean age: 32 years), and mean follow-up was 38 mo. The majority of patients (83.3%) received immunosuppressive therapy. Three patients (25%) achieved mucosal healing in both the small bowel and the colon, while disease activity was limited to either the small bowel or the colon in 5 patients (42%). It was possible to observe the entire gastrointestinal tract in 10 of the 12 patients (83%) who underwent PCC2., Conclusion: Only three patients in sustained corticosteroid-free clinical remission achieved mucosal healing in both the small bowel and the colon, highlighting the limitations of clinical assessment when stratifying disease activity, and the need for pan-enteric endoscopy to guide therapeutic modification.

Background and Aim: A significant proportion of patients presenting with obscure gastrointestinal bleeding (OGIB) have negative small bowel capsule endoscopy (SBCE) examinations, and yet remain at risk of rebleeding. We aimed to evaluate whether a second-look review of SBCE images using flexible spectral color enhancement (FICE) may improve the detection of potentially bleeding lesions., Materials and Methods: This was a retrospective, single-center study including consecutive patients with OGIB subjected to SBCE, whose standard white light examination was nondiagnostic. Each SBCE was reviewed using FICE 1. New findings were labeled as either P1 or P2 lesions according to bleeding potential. Patients were followed up to assess the incidence of rebleeding., Results: A total of 42 consecutive patients were included. Sixteen patients (38%) experienced rebleeding after a mean follow-up of 26 months. Review of SBCE images using FICE 1 enabled the identification of previously unrecognized P2 lesions, mainly angioectasias, in nine patients (21%) and P1 lesions, mainly erosions, in 26 patients (62%). Among patients who experienced rebleeding, 13/16 (81%) were diagnosed with P1 lesions with FICE 1 (P=0.043), whereas 3/16 (19%) had confirmed nondiagnostic SBCE and only 1/16 (6%) had newly diagnosed P2 (plus P1) lesions. An alternative source of bleeding outside the small bowel was found in only 3/16 (19%) patients with rebleeding during the follow-up., Conclusion: In a significant proportion of patients with OGIB, FICE 1 may detect potentially bleeding lesions previously missed under conventional white light SBCE. Review of nondiagnostic SBCE with FICE 1 may be a valuable strategy to obviate the need for further investigations in patients with OGIB, particularly for those who experience rebleeding.

Background and Study Aims: The Lewis score was developed to measure mucosal inflammatory activity as detected by small-bowel capsule endoscopy (SBCE). The aim of the current study was to validate the Lewis score by assessing interobserver correlation and level of agreement in a clinical setting., Patients and Methods: This was a retrospective, single-center, double-blind study including patients with isolated small-bowel Crohn's disease who underwent SBCE. The Lewis score was calculated using a software application, based on the characteristics of villous edema, ulcers, and stenoses. The Lewis score was independently calculated by one of three investigators and by a central reader (gold standard). Interobserver agreement was assessed using intraclass correlation (ICC) coefficient and Bland - Altman plots., Results: A total of 70 patients were consecutively included (mean age 33.9 ± 11.7 years). The mean Lewis score was 1265 and 1320 for investigators and the central reader, respectively. There was a high correlation, both for scores obtained for each tertile (first tertile r = 0.659 - 0.950, second tertile r = 0.756 - 0.906, third tertile r = 0.750 - 0.939), and for the global score (r = 0.745 - 0.928) (P < 0.0001). Interobserver agreement was almost perfect between the investigators and the central reader (first tertile ICC = 0.788 - 0.971, second tertile ICC = 0.824 - 0.943, third tertile ICC = 0.857 - 0.968, global score ICC = 0.852 - 0.960; P < 0.0001). The inflammatory activity was classified as normal (score < 135) in 2.9 % vs. 2.9 %, mild (score ≥ 135 - < 790) in 51.4 % vs. 55.7 %, and moderate to severe (score ≥ 790) in 45.8 % vs. 41.4 % of patients, respectively (P < 0.001)., Conclusion: A strong interobserver agreement was demonstrated for the determination of the Lewis score in a practical clinical setting, validating this score for the reporting of small-bowel inflammatory activity. The Lewis score might be used for diagnosing, staging, follow-up, and therapeutic assessment of patients with isolated small-bowel Crohn's disease., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background and Aims: Small bowel capsule endoscopy (SBCE) may detect proximal small bowel lesions that have been previously missed by ileocolonoscopy and small bowel imaging in patients with known ileal and/or colonic Crohn's disease (CD). We aimed to evaluate whether the therapeutic management is influenced by SBCE findings., Methods: Retrospective single center study. Inclusion of consecutive patients with known non-stricturing and non-penetrating ileal and/or colonic CD, submitted to SBCE to evaluate disease extension and activity, with ≥ 1 year follow-up. Lesions were classified with the Lewis score (LS) as non-significant (LS<135), mild (135≤LS≤790), or moderate-to-severe (LS>790). Therapeutic changes were assessed three months after SBCE., Results: Fifty consecutive patients (35±13 years, 52% females) were included. At ileocolonoscopy, disease location was ileal (L1) in 60%, colonic (L2) in 10% and ileocolonic (L3) in 30% of the patients. In 33 patients (66%) SBCE detected significant proximal lesions previously missed by other modalities. The proportion of patients on thiopurines and/or biologics before SBCE was 2/50 (4%); this was significantly higher three months after SBCE, 15/50 (30%), p=0.023. Treatment with thiopurines and/or biologics was started more often in patients with proximal small bowel lesions [13/33 (39%) vs. 1/17 (6%), p=0.011, relative risk (RR) 6.5], particularly when severe (6%, 36% and 45% of patients with non-significant, mild and moderate-to-severe inflammation, respectively)., Conclusions: SBCE diagnoses previously undetected lesions and it influences therapeutic management of CD, triggering an earlier introduction of immunomodulators and/or biological therapy., (Copyright © 2014 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.)

Introduction: Adherence to therapy is a key factor when analyzing the efficacy of a treatment in clinical practice. The aim of our study was to assess the frequency of non-adherence to treatment among patients with inflammatory bowel disease and evaluate which factors could be related., Material and Methods: One hundred thirty eight consecutive inflammatory bowel disease outpatients (55.8% with Crohn's disease and 44.2% with Ulcerative Colitis) filled in an anonymous questionnaire, which included information about demography, duration of the disease, specific therapy for inflammatory bowel disease, and data possibly related to extent of non-adherence to treatment. Statistics were performed with SPSS v.18.0. Categorical variables were compared with Fisher's exact test. A p value < 0.05 was considered statistically significant. Significant variables in univariate analysis were included in the logistic regression analysis., Results: Overall non-adherence was reported by 29.7% of patients. 70.7% of them reported unintentional non-adherence and 51.2% forgot at least one dose per week. Non-adherence was statistically associated with: short disease duration (p < 0.001); young age (p = 0.001); topical aminosalicylates (p = 0.005); the perception that medical therapy isn't effective enough (p = 0.007) and high educational level (p = 0.011). In a logistic regression analysis, topical aminosalicylates use (p = 0.004), short disease duration (p = 0.006) and young age (p = 0.027) were identified as significant predictors of non-adherence., Discussion: Young patients, patients with short disease duration and under topical aminosalicyates presented a higher risk for nonadherence to treatment., Conclusions: Gastroenterologist's attention should be focused on the identification of risk factors potentially involved in non-adherence to therapy and in the promotion of measures to improve it.

Background/aim: Small bowel capsule endoscopy (SBCE) is currently a fundamental tool in the etiological study of obscure gastrointestinal bleeding (OGIB). However, the impact of a negative exam and the risk of rebleeding are not entirely known. The aim of this study was to evaluate the outcomes of patients with OGIB and a negative SBCE examination in terms of follow-up duration, additional diagnostic studies, and achievement of a diagnosis as well as to assess the incidence of rebleeding and possible associated factors., Materials and Methods: We retrospectively analyzed 256 patients who consecutively underwent an SBCE examination for the study of OGIB between April 2006 and December 2011, and then selected the 79 whose results excluded potentially bleeding lesions. Eleven patients were lost to follow-up and the remaining 68 were eligible for a nested case-control analysis. Pre-SBCE and post-SBCE information was collected, including follow-up interval and incidence of rebleeding, defined as admission to the hospital for symptomatic anemia, need for blood transfusion, decrease in hemoglobin value of greater than 2 g/dl, or evidence of melena or hematochezia. Univariate analysis included age, sex, OGIB presentation (occult or visible), hemoglobin levels at presentation, and comorbidities., Results: In the 68 patients analyzed, the mean age was 52±18 years and 61.8% were women. The OGIB was occult in 54 patients (79.4%) and overt in 14 patients (20.6%). Patients were followed up for an average of 32 months. Thirty-nine patients (57.4%) underwent further diagnostic investigations during the period of follow-up and a cause for the gastrointestinal bleeding was found in five of them. Rebleeding was documented in 16 (23.5%) patients, occurring on average 15±13.8 months after the SBCE. Male sex was associated significantly with higher incidence of rebleeding (P=0.004)., Conclusion: Approximately one quarter of patients with OGIB and negative SBCE examination will experience rebleeding, with higher incidence among men; thus, a negative SBCE in this setting is not reassuring. As the vast majority of rebleeding episodes seem to occur within the following 2 years after SBCE, the maintenance of regular medical surveillance during the above-mentioned period of time after a negative SBCE seems advisable.