Reply to comment on "Ultrasonographic scores for ileal Crohn's disease assessment: better, worse or the same as contrast­enhanced ultrasound?

We read the comments by Nylund K et al. regarding our paper "Ultrasonographic scores for ileal Crohn's disease assessment: Better, worse or the same as contrast­enhanced ultrasound?". Intestinal ultrasound has become one of the most valuable developments in the past decade, a non-invasive, well-tolerated exam, with an easy repeatability, and absence of sedation, ionizing radiation, or preparation. Particularly for inflammatory bowel disease, where there is a lack of agreement of patient's symptoms with disease activity, in an era where the paradigm of mucosal healing is changing to transmural healing, and with the emergence of several therapies leading to repeated imaging surveillance, it is essential to highlight the role of intestinal ultrasound. Although intestinal ultrasound is an increasingly used tool to monitor inflammatory bowel disease activity, there is no widely accepted reproducible activity index, since the methodology for the development of the scores was shown to be insufficient in most studies and none have been adequately validated (Bots et al., J Crohns Colitis 12:920-9, 2018). In our study, we showed that the contrast-enhanced ultrasound (CEUS) peak enhancement derived from the time-intensity curve (TIC) is a promising non-invasive emerging method with a good accuracy to correlate clinical and endoscopic activity in the terminal ileum, superior to intestinal ultrasound scores relying on bowel wall thickness and colour Doppler.

Prolonged Gastric Transit Time in Small-Bowel Capsule Endoscopy: Which Patients Are at Risk and What Are the Implications?

BACKGROUND: Prolonged gastric transit time is a commonly described cause for incomplete capsule endoscopy examination. This study aimed to evaluate the prevalence and identify risk factors for prolonged gastric transit time and to assess its impact on the rate of incomplete examinations. METHODS: This is a retrospective study including patients undergoing small-bowel capsule endoscopy between January 2014 and August 2020. Patients with prolonged gastric transit time were consecutively included and patients without prolonged gastric transit time were randomized (controls) in a 1:2 ratio. Prolonged gastric transit time was defined as small-bowel capsule endoscopy remaining in the stomach for more than 1 hour, as checked with the routine use of the real-time viewer, requiring an intervention such as prokinetic administration and/or endoscopically assisted capsule delivery into the duodenum. RESULTS: Prolonged gastric transit time occurred in 45/957 patients (prevalence 4.7%). Both groups were similar regarding small-bowel capsule endoscopy indication and inpatient status. The mean small-bowel transit was similar between groups (4 hours 48 minutes ± 2 hours 11 minutes vs. 4 hours 38 minutes ± 1 hour 36 minutes; P =.74). Prolonged gastric transit time group did not have a significant higher rate of incomplete exams (P =.44) but presented more frequently with inadequate small-bowel preparation (P <.001). Older age (P =.046), female sex (P =.004), diabetes (P =.03), and psychotropic medication use (P =.02) were risk factors for prolonged gastric transit time. In multivariate analysis, female sex (odds ratio: 4.0; P =.002) and psychotropic medication use (OR: 4.6; P =.003) were predictors of prolonged gastric transit time. CONCLUSION: Prolonged gastric transit time was not associated with a higher rate of incomplete exams in our cohort but was associated with higher rate of inadequate small-bowel preparation. Female sex and psychotropic medication use were independent risk factors for prolonged gastric transit time.

Small Bowel CLEansing Assessment and Report (SB-CLEAR): Standardizing bowel preparation report in capsule endoscopy.

BACKGROUND AND AIM: Small-bowel (SB) cleansing is crucial to assess the reliability of capsule endoscopy (CE) findings. However, the presence of multiple grading systems is hampering their use in clinical practice. In 2020, Colon CLeansing Assessment and Report (CC-CLEAR) was created and validated. We sought to develop and validate a new score for the evaluation of the SB cleansing, adapted from CC-CLEAR, aiming to standardize CE reporting regarding the quality of preparation. METHODS: The new grading score, SB CLeansing Assessment and Report (SB-CLEAR), divided the SB into three tertiles, each being scored depending on the percentage of visualized mucosa (0, < 50%; 1, 50%-75%; 2, > 75%; 3, > 90%). The overall classification was a sum of each segment score, graded between excellent, good, and inadequate (0-5). Any segment scoring ≤1 resulted in inadequate overall classification. CE videos were prospectively evaluated by two experienced CE readers blinded to each other. RESULTS: We included 52 CEs, 41(78.8%) female, with a mean age of 57.9 ± 17.9 years. Inter-observer agreement was very strong for each tertile (first: r = 0.863; second: r = 0.865; third: r = 0.861; P < 0.001), which resulted in overall excellent correlation when considering the quality of preparation in all tertiles (r = 0.940; P < 0.001). By applying final classifications of "inadequate," "good," and "excellent," correlation between observers was also very strong (r = 0.875; P < 0.001). CONCLUSIONS: SB-CLEAR is an innovative and reproducible grading score for evaluation of SB preparation quality in CE, with overall excellent inter-observer agreement. Along with CC-CLEAR, this may become a valuable tool to uniformize reporting of bowel preparation quality in CE.

Stepping it up: Physical activity is associated with a lower incidence of prolonged gastric transit time in capsule endoscopy.

BACKGROUND AND AIM: Physical activity has been proposed as a potential factor influencing capsule endoscopy (CE) gastric transit time (GTT). However, there is no reported factual evidence confirming this association. We aimed to prospectively assess the effect of physical activity in the first hour of CE in the occurrence of prolonged GTT. METHODS: This is a prospective study including consecutive patients undergoing CE. For each patient, a step counter was attached to the CE register. The number of steps during the first hour of the procedure was registered. The main outcome was prolonged GTT (CE remaining in the stomach for > 1 h). Outcomes were adjusted for possible confounders by multivariate analysis. RESULTS: We included 100 patients, 60% undergoing small bowel CE and 40% colon CE. The mean number of steps in the first hour was significantly lower in patients with prolonged GTT (2009 ± 1578 steps) comparatively with those without prolonged GTT (3597 ± 1889 steps) (P < 0.001). On multivariate analysis including significant confounders, steps in the first hour were an independent predictor of prolonged GTT (P = 0.018). Single-handedly, the number of steps taken in the first hour had a good acuity for predicting prolonged GTT (area under the curve = 0.74; P < 0.001), with an optimal cut-off of 2000 steps (sensitivity 81.3% and specificity 70%). CONCLUSIONS: Physical activity during the first hour of CE significantly decreased the occurrence of prolonged GTT. These findings pave the way for further definition of clear instructions to give to patients undergoing CE.

The Prediction of Inadequate Colon Capsule Cleansing: A Cohort Selection Guided by CC-CLEAR.

Introduction: In order to optimize the rate of adequate cleansing in colon capsule, it may be important to identify risk factors that can predict a suboptimal colon preparation. Aim: To define predictive factors for inadequate bowel preparation in colon capsule, according to CC-CLEAR (Colon Capsule CLEansing Assessment and Report). Methods: Retrospective, single center, cohort study. Patients' demographics, data, and quality of bowel preparation, according to CC-CLEAR, were collected retrospectively. A univariate analysis tested the association between covariables and the outcome, inadequate cleansing. The statistically significant variables were included in multivariable logistic binary regression, and a receiver operating characteristic curve (ROC) assessment was performed. Results: We included 167 consecutive colon capsules. Sixty-eight percent (n = 114) of patients were female, with a mean age of 64 years. The main indication for colon capsule was previous incomplete colonoscopy, in 158 patients (94.6%). The colon capsules cleansing was graded as good or excellent in 96 patients (57.5%) and as inadequate in 71 (42.5%), according to CC-CLEAR. The variables inadequate previous colon cleansing (OR adjusted 41.72 [95% CI 12.57-138.57], p value < 0.001); chronic laxative (OR adjusted 4.86 [95% CI 1.08-21.79], p value = 0.039); antidepressant (OR adjusted 5.00 [95% CI 1.65-15.16], p value = 0.004), and impaired mobility (OR adjusted 5.54 [95% CI 1.17-26.31], p value = 0.031) were independently associated with the outcome inadequate cleansing, after adjusting for confoundment. The model presented an excellent discriminative power towards the outcome variable (AUC ROC 0.937 [CI 95% 0.899-0.975], p value < 0.001). Conclusion: A previous inadequate colon cleansing, the use of chronic laxative and antidepressant, or impaired mobility are predictors of inadequate colon capsule cleansing, as assessed by the CC-CLEAR. These 4 predictors come together as a model enabling an accurate categorization of the patients at major risk of inadequate bowel preparation for capsule colonoscopy, with an excellent discriminative power and performance, which seems useful for the selection of patients for tailored optimization of the colon cleansing protocol.

Introdução: Com o intuito de otimizar a taxa de preparações intestinais adequadas em cápsula do cólon, poderá ser importante identificar fatores de risco preditivos de preparações sub-ótimas. Objetivo: Definir fatores preditivos de preparação intestinal inadequada em cápsula do colon, de acordo com a CC-CLEAR (Colon Capsule CLEansing Assessment and Report). Métodos: Estudo de coorte retrospetivo, no qual as variáveis demográficas, clínicas e a qualidade de preparação intestinal, de acordo com a CCCLEAR, foram colhidas retrospetivamente. Uma análise univariada testou a associação entre as covariáveis e a variável outcome ­ preparação intestinal inadequada. As variáveis estatisticamente significativas foram incluídas num modelo de regressão logística binária e performance testada com a realização de curva ROC. Resultados: Incluímos 167 cápsulas do colon consecutivas. Sessenta e oito por cento (n = 114) eram do sexo feminino, com idade média de 64 anos. A principal indicação para cápsula do colon foi uma colonoscopia prévia incompleta, em 158 indivíduos (94.6%). As preparações intestinais em cápsula do colon foram classificadas como boas ou excelentes em 96 indivíduos (57.5%) e como inadequadas em 71 (42.5%), de acordo com a CC-CLEAR. As variáveis preparação cólica prévia inadequada [OR ajustado 41.72 (95% CI 12.57­138.57) valor p < 0.001]; uso crónico de laxante [OR ajustado 4.86 (95% CI 1.08­21.79) valor p = 0.039]; antidepressivo [OR ajustado 5.00 (95% CI 1.65­15.16) valor p = 0.004] e défice de mobilidade [OR ajustado 5.54 (95% CI 1.17­26.31) valor p = 0.031] foram independentemente associadas ao outcome, preparação intestinal inadequada, após o ajuste para o confundimento. O modelo apresentou um excelente poder discriminativo em relação ao outcome [AUC ROC 0.937 (CI95% 0.899­0.975) valor p < 0.001]. Conclusão: Uma preparação cólica prévia inadequada, o uso crónico de laxantes e antidepressivos e um défice de mobilidade são preditores de preparação intestinal inadequada em cápsula do cólon, de acordo com a CC-CLEAR. Estas 4 variáveis formam um modelo que permite a categorização, com excelente acuidade, de indivíduos com risco elevado para preparação intestinal inadequada em cápsula do colon, o que parece ser útil para uma otimização caso a caso do protocolo de preparação intestinal.

Finding Predictors of Azathioprine-Induced Pancreatitis in Patients With Inflammatory Bowel Disease.

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.

RHEMITT score: Predicting the risk of mid gastrointestinal rebleeding after small bowel capsule endoscopy: A prospective validation.

BACKGROUND AND AIM: The RHEMITT score (Renal disease; Heart failure; Endoscopic findings; Major bleeding; Incomplete SBCE; Tobacco; Treatment by enteroscopy) was the first score to accurately predict the individual risk of small bowel rebleeding after capsule endoscopy (SBCE). The aim of the study is on the prospective validation of the RHEMITT score. METHODS: Cohort of consecutive patients with mid-gastrointestinal bleeding (MGIB) submitted to SBCE and followed prospectively, during at least 12 months, since 2017 until 2020. Rebleeding was defined as an overt bleeding event (melena or hematochezia) or a hemoglobin decrease of at least 2 g/dL. The RHEMITT score was calculated for each patient and the rebleeding rates compared. The performance of the score was tested by calculating the area under curve of the receiver operator characteristic curve. A rebleeding-free survival was assessed, corresponding to the period between the date of SBCE and the date of the first post-SBCE rebleeding event. RESULTS: We included 162 patients, 102 (62.9%) were female, with a mean age of 64 years old. The sensitivities and specificities of the score grades for predicting rebleeding were as following: for low-risk patients, 0% (0-10%) and 28.8% (21.1-36.5%); for intermediate-risk patients, 23.3% (8.2-38.4%) and 72% (64.3-79.7%); for high-risk patients, 76.7% (61.6-91.8%) and 99.2% (97.7-100%), corresponding to an area under curve of the receiver operator characteristic of 0.988 (P < 0.001). Kaplan-Meyer plots were statistically different according to the attributed risk (log-rank P value <0.001; Breslow-Wilcoxon P value <0.001). CONCLUSION: The RHEMITT score performed with excellent discriminative power in predicting rebleeding risk, and we herewith propose a surveillance of MGIB patients guided by the RHEMITT score.

Apex Score: Predicting Flares in Small-Bowel Crohn's Disease After Mucosal Healing.

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 × 103/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.

Direct oral anticoagulants are associated with potentially bleeding lesions in suspected mid-gastrointestinal bleeding.

BACKGROUND AND AIM: Direct oral anticoagulants (DOACs) became a widespread alternative in anticoagulant therapy. Nevertheless, concerns are raised about their safety, with increased gastrointestinal bleeding rates being described. There are scarce studies regarding DOACs effect on small-bowel capsule endoscopy (SBCE) findings. We aimed to assess if the detection of lesions with high bleeding potential on SBCE was significantly different in patients treated with DOACs when compared to non-anticoagulated patients and to patients anticoagulated with other agents. METHODS: Cohort study including consecutive patients who underwent SBCE for suspected mid-gastrointestinal bleeding (MGIB) in 2019 and 2020. RESULTS: From 148 patients, 38 (25.7%) were anticoagulated, of which 26 (68.4%) with DOACs. P2 lesions were detected in 36.5% (n = 54) of the patients. These lesions were more frequently detected in patients under DOACs treatment when compared to non-anticoagulated patients (69.2% vs. 29.1%; p=.001), and also when compared to patients treated with other anticoagulants (69.2% vs. 33.3%; p=.037). No differences in P2 lesions detection were observed between patients treated with other anticoagulants and non-anticoagulated patients (33.3% vs. 29.1%; p=.747). In multivariate analysis, DOACs usage was significantly associated with higher detection rates of P2 lesions on SBCE, when adjusted for classical risk factors for MGIB (OR: 3.38; 95%CI = 1.23-9.26; p=.018). CONCLUSIONS: Despite their undeniable cardiovascular benefits and easy applicability, DOACs should still be considered with caution. These drugs were significantly associated with higher risk of potentially bleeding lesions on SBCE when compared to other anticoagulants and represent an independent risk factor for MGIB when adjusted for other variables.

Consumer Knowledge about Food Labeling and Fraud.

Food fraud is a growing problem and happens in many ways including mislabelling. Since lack of consumers' knowledge about mandatory food labeling information and different types of food fraud may impact public health, the present work assesses consumers' knowledge about these issues. Principal component analysis was performed to obtain a smaller number of uncorrelated factors regarding the usefulness and confidence of information displayed in food labels and the perception of food fraud. Results indicated that information displayed in food labels is useful, however the way it is presented may decrease consumer interest and understanding. Regarding respondents' confidence in foodstuffs, over half of them stated that information provided in food labels is reliable. However, a lack of confidence about food composition is observed in those processed foodstuffs such as meat products. Food fraud is recognized by more than half of respondents with a higher perception of those practices that imply a risk to public health than those related to economic motivation. Age and education of consumers influenced the perception of the information displayed in the food labels, their confidence and knowledge about food fraud. Implementation of education programs to increase consumer knowledge about food labelling and fraud is essential. Respondents' perception results could be use as guidelines by the food industry to improve food label design in order to enhance consumer understanding.

Hyperbaric oxygen therapy for refractory pyoderma gangrenosum: a salvage treatment.

A 42-year-old woman with left-side ulcerative colitis (E2 - rectum to splenic flexure) was diagnosed with pyoderma gangrenosum (PG) on a persistent ulcerated wound with peripheral erythema, in the left leg's gemelar surface, associated with tenderness and pain. Due to incomplete response to wound care and oral prednisolone, treatment with infliximab was initiated. As PG remained unresponsive after 12 weeks, the patient was switched to adalimumab with concomitant oral prednisolone. Before the second induction dosage of adalimumab, the refractory PG complicated with a superinfection by Pseudomonas aeruginosa A course of wide spectrum antibiotic therapy, daily wound care including negative pressure bandages and a physiotherapy rehabilitation programme controlled the infection, but the pyoderma persisted non-healed, with visible deep muscle layers and tendons. We proposed hyperbaric oxygen therapy in addition to weekly adalimumab, achieving full remission of the PG and recovering of the left foot's function.

Small-bowel transit time in capsule endoscopy: a determinant factor for the diagnosis of small-bowel bleeding.

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.

Colon Capsule CLEansing Assessment and Report (CC-CLEAR): a new approach for evaluation of the quality of bowel preparation in capsule colonoscopy.

BACKGROUND AND AIMS: Current colon capsule (CC) cleansing grading scales rely on subjective parameters and lack proper interobserver agreement. We should strive for higher intra- and interobserver agreement for the evaluation of the cleansing quality of CCs. Here we sought to validate a new grading scale for the evaluation of CC cleansing. METHODS: For the new grading scale, named Colon Capsule CLEansing Assessment and Report (CC-CLEAR), the colon was divided in 3 segments: right-sided, transverse, and left-sided colon. Each segment was scored according to an estimation of the percentage of visualized mucosa (0, <50%; 1, 50%-75%; 2, >75%; 3, >90%). The overall cleansing classification was a sum of each segment score, grading between excellent (8-9), good (6-7), and inadequate (0-5). Any segment scoring ≤1 resulted in inadequate overall classification. Videos were reviewed and scored using CC-CLEAR and the Leighton-Rex grading scale by 2 experienced operators blinded to each other. Kendall's coefficient evaluated inter- and intraobserver agreement. RESULTS: We included 58 consecutive CCs, corresponding to 75.9% women, with a mean age of 65 years. Overall cleansing CC-CLEAR classifications were as follows: reader A, 22.4% (n = 13) excellent, 31% (n = 18) good, and 46.5% (n = 27) inadequate; and reader B, 24.1% (n = 14) excellent, 22.4% (n = 13) good, and 53.4% (n = 31) inadequate. CC-CLEAR interobserver agreement was superior to the Leighton-Rex scale (Kendall's W .911 vs .806, respectively; P < .01). The intraobserver agreement for CC-CLEAR was excellent for both readers (P > .01). CONCLUSIONS: CC-CLEAR is a new practical and reliable grading scale for the evaluation of bowel preparation quality using a CC, with excellent inter- and intraobserver agreement.

Small Bowel Angioectasias Rebleeding and the Identification of Higher Risk Patients.

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.

P020 Proton Pump Inhibitor Therapy: Providing "Acid" Outcomes in Patients With Inflammatory Bowel Disease Under Infliximab Treatment.

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.

P051 Identifying High-Risk Patients With Acute Severe Ulcerative Colitis: Is the ACE Index Useful?

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.

Does Perianal Disease Influence the Efficacy of Combination Therapy in Crohn's Disease?

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.

Simplify to improve in capsule endoscopy - TOP 100 is a swift and reliable evaluation tool for the small bowel inflammatory activity in Crohn's disease.

Background: Capsule endoscopy is a widely recognized method to study the small bowel, including in patients with Crohn's disease (CD). The Lewis score (LS) is a valuable tool in this setting, able to assess inflammatory activity. TOP100, a new software tool of the RAPID Reader®, emerged to assist in the time-consuming capsule reading process, by automatically selecting 100 images that will most likely contain abnormalities.Aim: Evaluate the agreement between TOP100 and classic reading (CR) in determining LS in the setting of CD.Methods: Retrospective study including consecutive patients undergoing small bowel capsule endoscopy (SBCE) for suspected or established CD. One experienced reader performed CR and calculated the LS. Another experienced reader, blinded to the CR results, reviewed all SBCE videos using TOP100 and calculated the LS.Results: One hundred and fifteen patients were included. SBCE detected significant inflammatory activity (LS ≥135) in 64 patients (55.7%). We verified a strong agreement between the two methods of capsule reading (Kappa = 0.83, p < .001), with an agreement on 89.6% of the cases. The agreement was superior in moderate-to-severe inflammatory activity (Kappa = 0.92, p < .001). All cases of moderate-to-severe activity detected by CR were identified by TOP100 as significant inflammatory activity. A good agreement was verified in all tertiles (p < .001).Conclusions: Although the classical review of the entire video remains the gold standard, the TOP100 has been shown to be a useful tool in assisting the reader in a prompt calculation of LS, in particular for identifying patients with moderate-to-severe inflammatory disease.

RHEMITT Score: Predicting the Risk of Rebleeding for Patients with Mid-Gastrointestinal Bleeding Submitted to Small Bowel Capsule Endoscopy.

INTRODUCTION: Small bowel capsule endoscopy (SBCE) is the gold standard for mid-gastrointestinal bleeding (MGIB). No score has been developed to predict the risk of small bowel rebleeding after SBCE. OBJECTIVE: Creating a predictive small bowel rebleeding risk score for MGIB, after initial SBCE. METHODS: Retrospective, single center study, including SBCEs for MGIB, from June 2006 to October 2016. The minimum follow-up was 12 months. Univariate analysis and a multivariable Cox regression model tested the association with rebleeding. Statistically significant variables were used to compute the score. The score's accuracy was tested through a receiver operating characteristic (ROC) curve. A classification tree identified risk groups. For internal validation, we performed a 5-fold cross validation. RESULTS: We assessed 357 SBCEs for MGIB, of which 88 (24.6%) presented rebleeding during follow-up. Seven variables were used to compute a risk-predicting score - the RHEMITT score - namely, renal disease; heart failure; endoscopic capsule P1/P2 lesions; major bleeding; incomplete capsule; tobacco consumption; and endoscopic treatment. The score presented good accuracy toward the outcome (area under the curve ROC 0.842, 95% CI 0.757-0.927). We established 3 rebleeding risk groups: low (0-3 points); intermediate (4-10 points); and high (+11 points). CONCLUSION: A new MGIB score, named RHEMITT, accurately anticipates the individual risk of small bowel rebleeding after initial SBCE.

CECDAIic - a new useful tool in pan-intestinal evaluation of Crohn's disease patients in the era of mucosal healing.

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 (rs) 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 (rs = 0.82; p = .012) and a moderate correlation with C-reactive protein (CRP, rs = 0.50; p = .019).Conclusions: CECDAIic is a new score with excellent inter-observer agreement and strong correlation with calprotectin levels.