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Background CD is classically seen as a progressive disease leading to bowel damage and disability. Disability has been proposed by the Spirit-IOIBD consensus1 as an endpoint in disease modification trials. However, there is a paucity of data regarding disability in CD patients at diagnosis. Methods The “Crohn′s Disease Cohort Study” (CROCO) is an ongoing prospective cohort aiming to study the longitudinal evolution of bowel damage and disability following diagnosis of CD. All patients are included within 12 months following CD diagnosis and will be followed over 5 years with serial assessments of bowel damage and disability. At recruitment patients completed an IBD disability score questionnaire (DS),2 comprising several domains: mobility, self-care, major daily life activities, gastrointestinal-related problems, mental health and interaction with the environment. We here describe the baseline DS and its association with disease features, disease activity score (Harvey-Bradshaw Index), and biomarkers of disease activity, on the first patients recruited into CROCO. Results Ninety-four patients were recruited, of which 66 filled at least 80% of the questions in the DS questionnaire; of those 55% were male and median age at diagnosis was 30.6 [IQR 24.2;38.8]. The baseline visit occurred at a median time of 6 months [IQR 2.6;9.2] after CD diagnosis. Ileal involvement (L1/L3) was reported in 82% of patients; 68% had B1 phenotype, and 26% presented extra-intestinal manifestations. Overall, 32% of patients had been hospitalised, and 6% had a history of CD-related surgery. Regarding medication [from diagnosis to baseline], 55% received steroids, 56% immunosuppressants, and 65% Anti-TNF therapy. The median DS was 79 [IQR 67;108.2] (range: 49;198); only 2 patients (3%) patients presented DS>162 (the central value of the DS), indicating no or mild disability. No correlations were found between clinical or analytical biomarkers of disease activity at the time of recruitment (Table 1). Associations between disease features and DS are displayed in Table 2. A history of CD-related hospitalisation was associated with a significantly higher DS (103 [IQR 79;157] versus 76.5 [65.5;97], p=0.013). No other associations were observed. Conclusion In a cohort of newly diagnosed CD patients, disability was mostly mild and independent of disease activity, disease location or behaviour; around 1/3 required hospitalisation within the first year of diagnosis, which was associated with increased disability. These data add to the growing concept that newly diagnosed disease represents a window of opportunity for intervention.

Background and Aims To date, endoscopic retrograde colangio-pancreatography (ERCP) represents a major advance in gastro-intestinal endoscopy. The ERCP is a safe and minimally invasive therapy for pancreatic-biliary diseases. Adverse events (AEs) associated to ERCP are well described. However, little is known about acute kidney injury (AKI) associated to ERCP. The aim of this study was to evaluate the incidence of post-ERCP AKI and the risk factors for AKI development. The prognostic implication of ERCP-associated AKI in in-hospital mortality has been also assessed. Method In this prospective observational study, we evaluated 396 patients who underwent ERCP, from the 3rd January 2019 through the 27th January 2020. AKI was defined as an increase in serum creatinine (SCr) ≥ 0.3 mg/dl or an increase in SCr ≥ 50% and/or by a decrease in urine output to 0.5 ml/kg/hour for 6 hours, in the first 48 hours following ERCP. Logistic uni- and multivariable regression methods were used to determine predictors of AKI and in-hospital mortality. A two-tailed value Results In the studied group, median age was 69 years, interquartile range [IQ =17], 183 (46.21%) patients being males. ERCP-associated AKI was detected in 103 patients (26%). Univariable regression analysis showed that AKI was associated with baseline eGFR (r=0.246, P Conclusion In patients undergoing ERCP, AKI was a common complication and an independent risk factor for in-hospital mortality. These findings highlight the importance of early AKI and AKI-related risk factors recognition, in order to minimise the risk for ERCP-associated AKI and to improve the post-ERCP outcome of patients.

Background The optimal endoscopic target in early Crohn’s disease (CD) that limits long-term disease complications is unknown. Methods We analysed medical records from patients who had follow-up data since the end of CALM. Patients with Crohn’s disease endoscopic index of severity (CDEIS) scores at the end of CALM were included. The primary outcome was a composite of major adverse outcomes reflecting CD progression: new internal fistula/abscess, stricture, perianal fistula/abscess, CD hospitalisation, or CD surgery since the end of CALM. We compared median CDEIS and per cent improvement from baseline CDEIS. Youden index analysis was used to identify optimal CDEIS cut-off score associated with CD progression. Kaplan–Meier and Cox regression methods were used to compare rates of progression by different CDEIS targets. Multivariable models were adjusted for age, prior surgery, and stricturing behaviour. Results 110 patients with median age 28 (IQR 22–38) years, disease duration 0.2 (0.1–0.5) years, and median follow up of 3.1 (1.9–4.4) years were included. Eleven per cent had a history of stricture, 5.5% history of surgery, and 52% were originally in the tight control arm of the CALM study. Median CDEIS score at end of CALM was 3 (0–5.4) and 32 (29%) patients had disease progression. Baseline median CDEIS score was similar between those with and without progression [10.9 (7.5–15.5) vs. 11.9 (8–17.5)]. Median CDEIS score at the end of CALM was higher among those with progression [1.3 (0–5.1) vs. 4.9 (3–9.1), p < 0.001)]. Patients within higher quartiles of CDEIS score had higher rates of progression over time (Figure 1). Patients without disease progression had a greater median decrease in CDEIS score from baseline to end of CALM [90% (60–100%) vs. 50% (30–80%), p < 0.001]. The optimal CDEIS score cut-off was 2 with sensitivity 84%, specificity 60% and NPV 90% for progression. Patients with CDEIS ≤ 2 had less progression over time compared with patients with > 50% improvement from baseline CDEIS (not reaching CDEIS ≤ 2) and those not meeting either endpoint (Figure 2). On adjusted analysis, CDEIS score ≤ 2 was associated with a decreased risk of progression (aHR 0.23, 95% CI 0.09–0.56). Conclusion In early CD, a CDEIS score ≤ 2 is optimal cut-off associated with a lower risk of disease progression.

Background The Lémann index (LI) is the first instrument developed to measure cumulative structural bowel damage in Crohn’s disease (CD).1 We here report its validation. Methods This was an international, multicentre, prospective cross-sectional observational study. At each centre, 10 inclusions, stratified by known or suspected CD location and duration, were planned. Clinical examination and abdominal MRI had to be performed in all patients, and upper endoscopy, colonoscopy, and pelvic MRI according to CD location. Upper tract (UT), small bowel (SB), colon/rectum (CR), and anus (AN) were divided into 3, 20, 6 and 1 segments, respectively. History of previous surgery was collected per segment. For each segment, 1 gastroenterologist and 1 radiologist per centre, identified the presence of predefined stricturing and/or penetrating lesions of maximal severity (grade 1 to 3) at each investigation. They provided a damage evaluation for each non-resected segment ranging from 0 to 10, 10 corresponding to the damage of a completely resected segment. Investigator organ damage evaluation was calculated as the sum of segmental damage evaluations. Finally, investigators provided a global damage evaluation from 0 to 10 for each patient according to the 4 organ damage scores, calculated as a function of investigator organ damage evaluations, resections and a total number of segments. The correlation between the investigator global damage evaluation and the LI was high on the construction sample, since coefficients to derive the LI were estimated by maximising this correlation, and is expected to be lower on data obtained in new patients by new investigators. Thus, the LI would be validated if the linear regression model of investigator global damage evaluation on LI shows a still high correlation. The same applies to investigator damage evaluation of each organ and each organ component of the LI. Results 134 patients were included in 15 centres, 7 to 10 per centre. Correlation coefficients between investigator organ damage evaluation and each organ component of the LI were 0.91, 0.96, 0.95, and 0.81, for UT, SB, CR and AN, respectively. The correlation coefficient between investigator global damage evaluation and the LI was 0.98 (Figure 1). Proportions of the investigator organ damage evaluation variance explained by each organ component of the LI were 82%, 91%, 89%, 65%, for UT, SB, CR, AN, respectively. This proportion was 96% for the investigator global damage evaluation and the LI. Conclusion The Lémann index is now a validated index to assess cumulative bowel damage in CD that can be used in epidemiological studies and disease modification trials. Reference

The epidemiology of inflammatory bowel disease [IBD] in Eastern Europe is poorly understood, particularly with regard to diagnostic delay. Here we investigated the factors leading to delayed diagnosis and the effect of the delay on several disease progression and outcome measures.A total of 1196 IBD cases [682 ulcerative colitis [UC], 478 Crohn's disease [CD], 36 indeterminate colitis] from the Romanian national registry IBDPROSPECT were reviewed. Standard clinical and demographic factors were evaluated as predictors of a long diagnostic delay in both CD and UC. Diagnostic delay was subsequently evaluated as a potential risk factor for bowel stenoses, bowel fistulas, perianal fistulas, perianal surgery, and intestinal surgery in CD patients.The median diagnostic delay was significantly longer in CD [5 months] than in UC [1 month] patients [p0.001]. Compared with 5 months for UC patients, 75% of CD patients were diagnosed within 18 months of symptom onset. In CD patients, extra-ileal location was a protective factor (odds ratio [OR], 0.5; p = 0.03), whereas being an active smoker [OR, 2.09; p = 0.01] and symptom onset during summer [OR, 3.35; p0.001] were independent risk factors for a long diagnostic delay [18 months]. In UC patients, an age40 years was a protective factor [OR, 0.68; p = 0.04] for a long delay. Regarding outcomes, a long diagnostic delay in CD patients positively correlated with bowel stenoses [OR, 3.38; p0.01] and any IBD-related surgery [OR, 1.95; p = 0.03] and had a positive trend for intestinal fistulas [OR, 2.64; p = 0.08] and perianal fistulas [OR, 2.9; p = 0.07]. Disease duration since diagnosis positively correlated with bowel stenoses [OR, 1.04; p = 0.04], any IBD-related surgery [OR, 1.04; p = 0.02], and intestinal surgery [OR, 1.07; p0.01].A long diagnostic delay in IBD correlates with an increased frequency of bowel stenoses and need for IBD-related surgery.

Background and Aims: The ECCO-EpiCom study investigates the differences in the incidence and therapeutic management of inflammatory bowel diseases [IBD] between Eastern and Western Europe. The aim of this study was to analyse the differences in the disease phenotype, medical therapy, surgery, and hospitalization rates in the ECCO-EpiCom 2011 inception cohort during the first year after diagnosis. Methods: Nine Western, five Eastern European centres and one Australian centre with 258 Crohn’s disease [CD], 380 ulcerative colitis [UC] and 71 IBD unclassified [IBDU] patients [female/male: 326/383; mean age at diagnosis: 40.9 years, SD: 17.3 years] participated. Patients’ data were registered and entered in the web-based ECCO-EpiCom database [www.epicom-ecco.eu]. Results: In CD, 36 [19%] Western Europe/Australian and 6 [9%] Eastern European patients received biological therapy [ p = 0.04], but the immunosuppressive [IS] use was equal and high in these regions [Eastern Europe vs Western Europe/Australia: 53% vs 45%; p = 0.27]. Surgery was performed in 17 [24%] CD patients in Eastern Europe and 13 [7%] in Western Europe/Australia [ p < 0.001, p LogRank = 0.001]. Of CD patients from Eastern Europe, 24 [34%] were hospitalized, and 39 [21%] from Western Europe/Australia, [ p = 0.02, p LogRank = 0.01]. In UC, exposure to biologicals and colectomy rates were low and hospitalization rates did not differ between these regions during the 1-year follow-up period [16% vs 16%; p = 0.93]. Conclusions: During the first year after diagnosis, surgery and hospitalization rates were significantly higher in CD patients in Eastern Europe compared with Western Europe/Australia, whereas significantly more CD patients were treated with biologicals in the Western Europe/Australian centres.

Endoscopic and deep remission at 1 year prevents disease progression in early Crohn's disease : long-term data from CALM

Cost analysis in a prospective European population-based inception cohort : is there a cost-saving effect of biological therapy?

Background and aims: The aim of the present study was to validate the IBD (inflammatory bowel diseases) incidence reported in the 2010 ECCO-EpiCom (European Crohn's and Colitis Organization–Epidemiological Committee) inception cohort by including a second independent inception cohort from participating centers in 2011 and an Australian center to investigate whether there is a difference in the incidence of IBD between Eastern and Western European countries and Australia. Methods: Fourteen centers from 5 Eastern and 9 Western European countries and one center from Australia participated in the ECCO-EpiCom 2011 inception cohort. Patients' data regarding disease type, socio-demographic factors, extraintestinal manifestations and therapy were entered into the Web-based EpiCom database, www.ecco-epicom.eu. Results: A total of 711 adult patients were diagnosed during the inclusion year 2011, 178 (25%) from Eastern, 461 (65%) from Western Europe and 72 (10%) from Australia; 259 (37%) patients were diagnosed with Crohn's disease, 380 (53%) with ulcerative colitis and 72 (10%) with IBD unclassified. The mean annual incidence rate for IBD was 11.3/100,000 in Eastern Europe, 14.0/100,000 in Western Europe and 30.3/100,000 in Australia. Significantly more patients were diagnosed with complicated disease at diagnosis in Eastern Europe compared to Western Europe (43% vs. 27%, p = 0.02). Conclusion: Incidence rates, disease phenotype and initial treatment characteristics in the 2011 ECCO-EpiCom cohort were not significantly different from that reported in the 2010 cohort. * Abbreviations: : IBD : inflammatory bowel diseases CD : Crohn's disease UC : ulcerative colitis IBDU : inflammatory bowel disease unclassified ECCO : European Crohn's and Colitis Organization EpiCom : Epidemiological Committee IRR : incidence rate ratio CI : confidence interval EC-IBD : European Collaborative Study on Inflammatory Bowel Disease ACCESS : Asia-Pacific Crohn's and Colitis Epidemiology Study SE : standard error

Background and Aims: The incidence of inflammatory bowel disease (IBD) is increasing in Eastern Europe possibly due to changes in environmental factors towards a more "westernised" standard of living. The aim of this study was to investigate differences in exposure to environmental factors prior to diagnosis in Eastern and Western European IBD patients. Methods: The EpiCom cohort is a population-based, prospective inception cohort of 1560 unselected IBD patients from 31 European countries covering a background population of 10.1. million. At the time of diagnosis patients were asked to complete an 87-item questionnaire concerning environmental factors. Results: A total of 1182 patients (76%) answered the questionnaire, 444 (38%) had Crohn's disease (CD), 627 (53%) ulcerative colitis (UC), and 111 (9%) IBD unclassified. No geographic differences regarding smoking status, caffeine intake, use of oral contraceptives, or number of first-degree relatives with IBD were found. Sugar intake was higher in CD and UC patients from Eastern Europe than in Western Europe while fibre intake was lower (p.

Natural disease course of inflammatory bowel disease unclassified in a prospective European population-based inception cohort-the Epi-IBD cohort

Disease course during the first five years following diagnosis in a prospective European population-based inception cohort - the ECCO-EpiCom cohort

Change in Crohn's disease behavior in a prospective European population-based inception cohort - the ECCO-EpiCom cohort

Frequency of anaemia and anaemia subtypes in east-west European inception cohort : an ECCO-EpiCom cohort study

The risk of proximal disease extension in patients with limited ulcerative colitis in a prospective European population-based inception cohort - the ECCO-EpiCom cohort

The cost of investigations and medical treatment including biological therapy in a European inception cohort from the biological era : An ECCO-EpiCom study

C. Gheorghe1, A. Dimitriu1 *, R. Iacob1, M. Cojocaru1, C. Lupei1, R. Vadan1, D. Dobru2, A. Trifan3, M. Tantau4, A. Goldis5, G. Constantinescu6, S. Gologan7, B. Mateescu8, D. Gheonea9, L. Gheorghe1, M. Diculescu1, on behalf of the IBDPROSPECT Study Group. 1Fundeni Clinical Institute, Digestive Diseases and Liver Transplantation Center, Bucharest, Romania, 2Municipal Hospital Targu Mures, Gastroenterology, Targu Mures, Romania, 3Gastroenterology and Hepatology Institute Iasi, Gastroenterology, Iasi, Romania, 43rd Medical Clinic Cluj-Napoca, Gastroenterology, Cluj-Napoca, Romania, 5District Hospital Timisoara, Gastroenterology, Timisoara, Romania, 6Floreasca Emergency Hospital, Gastroenterology, Bucharest, Romania, 7Elias Universitary Hospital, Gastroenterology, Bucharest, Romania, 8Colentina Clinical Hospital, Gastroenterology, Bucharest, Romania, 9University of Medicine and Pharmacy Craiova, Romania, Immunology, Craiova, Romania

Results: Two hundred seventy-five patients (143 males and 132 females) were colliged. Mean age was 31.8 years old [8 65]. They were followed during a mean period of 23.3 months. Familial form (FF) of CD was diagnosed in 32 patients (11.6%). Age at onset of CD, site and phenotype of CD were similar in FF and sporadic forms (SF) (respectively p = 0.2, p = 0.6 and p = 0.9). Upper gastrointestinal tract involvement, anoperineal lesions and complications such as abcess and severe acute colitis were as common in FF as in SF of CD. Extraintestinal manifestations were significantly more frequent in FF than SF (45.1% versus 21.5%, p = 0.005). Corticosteroids were more commonly prescribed in FF than in SF (75% versus 55%, p = 0.026). Overall, patients with FF receive more immunosuppressive therapy than patients with SF (65.6% versus 48.5%, p = 0.05) mainly methotrexate (12.5% versus 1.6%; p = 0.008). There was no difference between FF and SF of CD with regard of Biotherapy with anti-TNF agents (15% versus 8%; p = 0.1) and surgery (8% versus 35%, p = 0.2). Conclusions: Despite comparable clinical characteristics of both groups, extraintestinal manifestations may result in more common use of corticosteroids and immunosuppressive therapy in FF than in SF of CD.

Conclusions: Accurate diagnosis of IBD is made by experienced physicians. The patients having suspicious symptoms must be sent to most experienced physicians without delay. The time from onset of symptoms to diagnosis was median 8.3 months in CD, 4.5 months in UC in IBSEN study. Our study results were generally compatiple with the literature. Early diagnosis can decrease the risk of progression to complicated disease that is required more effective and expensive drugs.