bluuebunny/crossref_metadata_2025 huggingface dataset:
P113 Defining the Safety of Early Ileostomy Closure After IPAA
Authors: Clancy C , Connelly T , Jia X , Lipman J , Lightner A , Hull T , Steele S , Holubar MD- MS S
Published: January 2022

Background

Patients undergoing ileal pouch-anal anastomosis commonly wish to have their ileostomy reversed as quickly as possible. The safety of ileostomy reversal (DLI-R) within 8 weeks of surgery has not been established. Our hypothesis is early closure before 8 weeks is associated with negative outcomes.

Methods

Patients who underwent primary IPAA with DLI from 2000 – 2021 from our Pouch Registry were retrospectively reviewed and stratified into groups based on timing of ileostomy closure: very early, routine (< 8 weeks, 56–116 days, respectively). Reasons for early closure were reported. Our primary outcome was overall complication rates according to timing of closure. Univariate analysis was used to compare categorical variables between groups.

Results

2,000 patients underwent DLI-R following IPAA at a very early or routine timepoint: 3-stage 62%, 2-stage 38%; median age 39.2. DLI-R was performed very early in 92 patients and early routine in 1,908. Median time to closure in the very early group is 49 days and in the early routine group was 93 days. There were no differences between the two groups in age or BMI, but the very early group had a higher proportion of females (62% vs 41.5% p<0.001) and a higher proportion of patients with ASA 1–2 (65.2% vs 51.9% p<0.02). Reasons for DLI-R in the very early group were stoma related problems in 39 patients (43.3%) with scheduled closure in 51 patients (56.7%). Complications following DLI-R occurred in 11.3% of patients overall. The complication rate in the very early group was 17.4% compared to 11% in the routine group (p=0.09) and are shown in Table 1. When the patients in the very early group were stratified according to reason for DLI-R those reversed early for stoma related problems had a complication rate of 25.6% compared to 11% in the early routine group (p=0.03). Patients undergoing scheduled DLI-R in the very early group did not have higher complication rates than the routine group (11.8% vs 11% respectively, p=1.0).

Conclusion

DLI-R at <8 weeks following IPAA does not appear to be associated with a statistically higher rate of complications compared to closure in a standard time frame. However, when patients were reversed early due to complications associated with their stoma they had worse outcomes.
P127 Type I collagen degradation fragments (C1M) and human neutrophil elastase-derived fragments of calprotectin (CPa9-HNE) reflect biochemical and endoscopic disease activity in patients with Inflammatory Bowel Disease
Authors: Bourgonje A R , Alexdottir M , Loveikyte R , Pehrsson M , Bay-Jensen A C , van Dullemen H M , Visschedijk M C , Festen E A M , Weersma R K , Karsdal M A , Faber K N , Mortensen J H , Dijkstra G
Published: January 2022

Background

Crohn’s disease (CD) and ulcerative colitis (UC) are characterized by intestinal inflammation and increased extracellular matrix (ECM) remodeling, which are key pathophysiological mechanisms in patients with IBD and highly related to mucosal damage. Alterations in intestinal ECM turnover as well as macrophage and neutrophil activity may be reflected by secreted products that are released into the systemic circulation. In this study, we aimed to investigate associations between serum biomarkers of neutrophil activity (serum calprotectin) and collagen degradation (mucosal damage), and disease activity in patients with IBD.

Methods

Serological biomarkers of collagen formation (PRO-C3, PRO-C4, PRO-C6), matrix metalloproteinase (MMP)-mediated collagen degradation (C1M, C3M, C4M, C4G, C6Ma3) and intestinal inflammation (VICM [macrophage activity], human neutrophil elastase-derived fragment of calprotectin (CPa9-HNE [serum calprotectin, neutrophil activity]) were measured using Protein FingerPrint assay (PFA) technology in 100 patients with IBD (CD: n=44; UC: n=56). Biochemical disease activity was assessed using C-reactive protein (CRP) levels and available faecal calprotectin (FCal) levels. Endoscopic disease activity was determined using the Simple Endoscopic Score for CD (SES-CD) and Mayo endoscopic subscore for UC.

Results

C1M strongly associated with elevated CRP levels (defined as >5mg/L, P<0.001) in patients with IBD and significantly associated with faecal calprotectin levels in patients with UC (Spearman’s ρ=0.75, P<0.001). In patients with CD, C1M reasonably discriminated between patients with mild and moderate-to-severe endoscopic disease activity (AUC=0.73, P=0.01), whereas this discrimination was more subtle in patients with UC (AUC=0.68, P=0.08). CPa9-HNE levels were significantly increased in patients with elevated CRP levels (P=0.002 for both CD and UC) and associated best with faecal calprotectin levels in patients with CD compared with UC (CD: ρ=0.43, P=0.06; UC: ρ=0.20, P=0.45). Finally, CPa9-HNE levels were able to discriminate between mild and moderate-to-severe endoscopic disease activity in patients with CD (AUC=0.75, P<0.01).

Conclusion

C1M and CPa9-HNE levels associate with biochemical (CRP, FCal) and endoscopic disease activity in patients IBD, where C1M demonstrated higher accuracy in UC and CPa9-HNE appeared to be more useful in CD in this cohort. Therefore, C1M and CPa9-HNE could serve as surrogate biomarkers for the assessment of disease activity in patients with UC and CD, respectively. Our results should be validated in additional prospective, larger patient cohorts to corroborate these findings.
P132 An audit of quality of histopathology reporting of colorectal mucosal biopsies for the diagnosis and assessment of Inflammatory Bowel Disease
Authors: Mcalinn J , Feakins R
Published: January 2022

Background

Inflammatory Bowel Disease (IBD) biopsies form a large part of the reporting workload of most histopathology departments. Published UK and European guidelines include recommendations on how best to report these biopsies for IBD diagnosis and assessment 1,2. The purpose of this audit is to assess whether biopsies reported at our institution adhere to these guidelines and to discuss potential improvements in IBD histology reporting.

Methods

An electronic search of histopathology records was conducted using diagnostic results coded for Inflammatory Bowel Disease. The search yielded 56 cases. Percentage compliance was measured for 24 criteria under the following headings: Clinical details and processing; Macroscopic description/processing; Microscopic report; and Summary/conclusion. Satisfactory compliance was set at 90%, using the recommendations from the UK Royal College of Pathologists3.

Results

Of the 24 criteria, 14 were accepted as adhering to the guidelines. Noteworthy results for non-compliance were:

Duration of disease stated: 86%

Endoscopy findings provided: 79%

Actual copy of endoscopy report provided: 4%

Endoscopist states probability of IBD: 63%

Sampling is adequate and appropriate: 50%

Distribution within sites is recorded: 68%

Comment on presence or absence of basal plasmacytosis is made: 32%

Preference for Ulcerative Colitis or Crohn’s disease is stated, or inability to subclassify is recorded: 71%

Conclusion

There is potential for improvement in IBD reporting at our site.

Problems identified included lack of access to endoscopy reports, inappropriate sampling at endoscopy, and absence of endoscopy comments on the probability of IBD. Discussion of audit results with the endoscopists and creation of a regular IBD multidisciplinary team meeting (MDTM) could help to promote communication between departments and provide a route towards higher quality reporting.

Areas of concern regarding microscopic reporting and interpretation included failure to describe distribution of inflammation within sites, absence of a record of basal plasmacytosis, and failure to state a preference for Ulcerative Colitis or Crohn’s disease. A lack of clarity in these areas has the potential to impact patient management negatively. Recommendations included consideration of a structured histology reporting system such as a template or the PAID approach available in the British Society of Gastroenterology guideline2.

References

1. F Magro et al ‘European consensus on the histopathology of inflammatory bowel disease’

2. RM Feakins, ‘IBD biopsies: updated BSG reporting guidelines’

3. RM Feakins, RCPath Cellular pathology audit template ‘An audit of quality of reporting of colorectal mucosal biopsies taken for the diagnosis and assessment of IBD’
P157 Biologic therapy and short disease duration correlate with no dysplasia when colectomy performed for ulcerative colitis
Authors: Ori B , Shlomo Y , Petachia R , Eran G , Koslowsky B
Published: January 2022

Background

15–20% of ulcerative colitis (UC) patients will eventually undergo total proctocolectomy (TPC) with or without a restorative pouch following. The two main indications include refractory UC and advanced colonic neoplasia. Risk factors associated with TPC in the biological era are not clarified. The aim of the study was to compare TPC performed with a finding of neoplasia to all other indications.

Methods

An observational retrospective analysis of all TPC performed at a single tertiary referral medical center between 2003–2020, was performed.

Results

Seventy-nine patients were included, 25 (31%) with neoplasia and 54 (69%) for all other indications. Average age was 42, 62% men, and 12.5 years of disease prior to surgery. Out of the neoplasia group, only 6 (24%) and 8 (32%) were exposed to biologics and steroids prior to surgery, opposed to 36 (66.6%) and 38 (70%) in the controls, p=0.005 and 0.001 respectively. Average years of disease was 18.7± 13 for neoplasia group compared to 9.7± 11 years for the controls, p<0.001. The major indications for TPC in the neoplasia group were a finding in colonoscopy 16 (64%) and treatment failure 5 (20 %), opposed to 4 (7%) and 43 (80%) in the controls, p<0.001 for both, respectively. Short term complications and long term complications occurred in 15 (60%) and 6 (24%) of in the neoplasia group compared to 39 (72%) and 33 (61%) in the controls, p=0.27 and 0.002, respectively. Hemoglobin was higher and albumin lower in the neoplasia group. Two-step procedures and three-step procedures were performed on 12 (48%) and 1 (4%) of patients in the neoplasia group compared to 27 (50%) and 16 (29%) in the controls, p=0.86 and 0.01, respectively.

Conclusion

Even in the biologic era, neoplasia encounters nearly one-third of TPC procedures. Short disease duration and use of biologics are correlated with a decreased risk for neoplasia. Long term complications are less common when TPC performed due to neoplasia.
P176 The effect of induction therapy with infliximab or vedolizumab on hepcidin and iron status in patients with Inflammatory Bowel Disease
Authors: Loveikyte R , Bourgonje A R , van der Reijden J J , Bulthuis M L C , Hawinkels L J A C , van Goor H , van der Meulen-de Jong A E , Dijkstra G
Published: January 2022

Background

Differentiating absolute iron deficiency from functional iron restriction is challenging in active Inflammatory Bowel Disease (IBD). Hepcidin, the systemic iron regulator, could be the key in the diagnosis and management of absolute iron deficiency. In this study, we assessed hepcidin as a diagnostic iron deficiency marker and we explored the relationship between hepcidin, inflammation, hypoxia, and iron deficiency in patients receiving induction therapy with infliximab (IFX) or vedolizumab (VEDO).

Methods

130 patients with IBD, who received induction therapy with IFX or VEDO for active disease, were included in this study. Clinical and biochemical data were extracted from medical records. Serum samples at baseline and week 6 of induction therapy were retrieved from the University Medical Center Groningen (UMCG) biobank and analysed for: hepcidin, inflammation (e.g., interleukins [IL] 6, 10, and Tumour Necrosis Factor-α [TNFα]), oxidative stress (free thiols), and hypoxia (e.g., erythropoietin [EPO], Macrophage Inflammatory Protein-3α [MIP3α]). For comparison, serum samples from 50 age- and gender-matched healthy controls were obtained from pre-donation biobank at the UMCG. Response to therapy was defined by either General Physician’s Assessment at week 14 of induction therapy, normalisation or at least a three-point decrease in clinical scores: Harvey-Bradshaw Index (HBI) for Crohn’s Disease, Simple Clinical Colitis Activity Index (SCCAI) for ulcerative colitis.

Results

Hepcidin correlated with ferritin and sTfR/log ferritin index [ρ = 0.74 and ρ = -0.79, respectively; P<0.001 for both markers], while inflammation- and hypoxia-associated markers showed only marginal correlations. Hepcidin accurately identified absolute iron deficiency: AUC(hepcidin) = 0.89 [95% CI: 0.82–0.95; P<0.001]. Induction with either IFX or VEDO decreased hepcidin [13.5 ng/mL vs. 9.5 ng/mL; P<0.001], ferritin [45.5 ug/L vs. 37.0 ug/L, P<0.05], and inflammatory markers at week 6, while transferrin increased [2.4 g/L vs. 2.5 g/L, P<0.001]. In total, 75.4% of patients responded to the induction therapy. Hepcidin and ferritin decreased, while transferrin increased (P<0.001 for all changes) in patients who responded to the therapy. In addition, hypoxia (EPO and MIP3α) and inflammatory markers such as faecal calprotectin, IL-6, IL-22, and TNFα improved significantly. In contrast, none of these improvements were observed in patients who did not respond to the therapy.

Conclusion

Hepcidin reflects iron deficiency in active IBD, but inflammation masks the severity of the deficiency. Induction therapy with either IFX or VEDO modulates hepcidin and iron indices, especially in patients who respond to the therapy.
P187 Major Depression in patients with Ulcerative Colitis and its relationship with clinical activity
Authors: Facanali C , Sobrado C W , Meirelles Carregaro B , Borba M R , Nahas S C
Published: January 2022

Background

In the last decade, there has been an increase in manuscripts published around the world related to psychological aspects in patients with IBD, suggesting a relationship between depression and IBD. Depressive symptoms seem to be able to aggravate ulcerative colitis (UC)¹, however there is a need for a clearer characterization of the sample and disease activity²,³. The aim of the study is to estimate the prevalence of major depression (MD) in patients with UC and to evaluate its relationship with the clinical activity and other diseases characteristics.

Methods

From October 2020 to May 2021, 299 patients with UC were evaluated using the Patient Health Questionnaire-9 (PHQ-9) scale, where absent depressive symptoms range from 0–4 points, mild depressive symptoms 5–9, moderate depressive symptoms 10–14, moderately-severe depressive symptoms 15–20, severe depressive symptoms greater than 20. MD was defined by PHQ-9 ≥10.

Data were prospective analyzed,regarding socio-demographic characteristics, surgeries, current treatment; clinical activity and extent of disease were assessed by montreal classification. The association of characteristics with the MD risk was verified using chi-square tests or Fisher’s exact tests or likelihood ratio, and quantitative characteristics were compared according to MD risk categories using Student’s t-tests or Mann-Whitney tests. All statistical tests were performed with a 5% significance level.

Results

The prevalence of MD in UC patients was 35.8%. The main socio-demographic characteristics and MD risk are described in Figure 1. Figure 2 shows that, separately, sex, disease activity, hemoglobin and hematocrit statistically influenced the risk of MD (p < 0.05). There was no association between disease extension, surgeries performed along the disease course or current drug treatment with MD (p > 0.05).

Together, gender influenced the MD risk in UC patients, regardless of the other characteristics evaluated, with female patients having a 2.63 times the chance of MD than male patients (Odds Ratio [OR] 2.63. 95% confidence interval [CI] 1, 41–4.89; p 0.002).

Conclusion

Our study confirms the high risk of MD among UC patients and is significantly related to the disease clinical activity. Psychological assessment of UC patients, in addition to objective measures of disease activity as an integral part of IBD care, is necessary, aiming to help improve the quality of life and maintain remission.
P190 Implementation of IBD symptom diary – Case Finnish IBD register
Authors: Mustonen Real World Data Manager A , Asikainen S , Toivonen T , Jussila A T
Published: January 2022

Background

BCB MyHealth application is a digital monitoring system of patient reported outcomes (PROMs) fully integrated and synchronized with the Finnish IBD Register, which delivers information about the patients’ disease and state of health. Our system monitors patients’ symptoms and well-being only at one point. There is a need to monitor patients’ symptoms and well-being more closely between follow-up visits. Therefore, we developed a digital daily self-monitoring symptom diary service, Feeling application, which is suitable for all patients with IBD in everyday practice. In addition, our goal was to create a system that allows IBD-patients to view their own parameters used to monitor treatment.

Methods

As a part of MyHealth, we developed the Feeling app (Figure 1) with Tampere University Hospital. Project group included gastroenterologists, IBD-nurses, and the hospitals’ senior medical advisor of health technology assessment. The Feeling app is a digital daily self-monitoring symptom diary service intended for IBD-patients. The system supports biometric authentication (Figure 2) and saves responses to IBD Register database.

Figure 1. IBD Symptom Diary

Figure 2. Biometric authentication

Results

Feeling app enables continuous home-monitoring of patients with IBD. This symptom diary allows patients to monitor their symptoms and well-being daily. They can see their own answers and how their symptoms and well-being have developed weekly, monthly, or annually. During treatment follow-up, the Feeling app also visualizes lab parameters used to monitor treatment, such as CRP, calprotectin and hemoglobin values, which are derived from the IBD register (Figure 3). In addition, certain endoscopy related parameters, such as SES-CD and Mayo Score are visualized for the patient. Health care professionals (HCPs) can see summary view all the data that the patient has inserted in the Feeling app in IBD register and the data is visualized in real time. Tampere University Hospital started to use the Feeling app in 2021.

Figure 3. Summary view

Conclusion

The Feeling app provides new ways to support patient care and is an efficient tool for long-term data collection. The opportunity of patients to monitor the development of their symptoms and well-being, and to see the lab parameters used to monitor treatment may improve adherence to treatment. With efficient data collection we have increased opportunity to utilize the data for AI activities such as synthetic data and outcomes prediction.
P192 First event of acute intestinal inflammation and the risk of progression to Inflammatory bowel disease: a retrospective analysis
Authors: Levartovsky A , Ovdat T , Barash Y , Ben-Shatach Z , Skinezes Y , Jesin S , Klempfner R , Grossman E , Kopylov U , Ben-Horin S , Ungar B
Published: January 2022

Background

Episodes of acute ileitis or colitis have been associated with future development of inflammatory bowel diseases (IBD). Nevertheless, the incidence of IBD among patients diagnosed with acute intestinal inflammation is currently unknown. We aimed to assess the risk for future development of IBD based on clinical and radiographical features of patients presenting with abdominal symptoms to the emergency department (ED) and undergoing urgent computerized tomography (CT) of the abdomen.

Methods

We created an electronic data repository of all patients visiting the ED at our medical center and undergoing abdominal CT between 2011–2020. We searched the computerized database for patients diagnosed with Crohn’s disease (CD) or ulcerative colitis (UC) during a visit to the gastroenterology department within maximal follow-up time of 9 years from the index-admission to the ED. Statistical analysis including multivariate models identified the risk and possible predictors of patients to develop IBD.

Results

Overall, 1551 patients visited the ED and underwent abdominal imaging with abnormal findings. The radiographic parameters reported the most on abdominal CT scans were bowel wall thickening, fat infiltration, and abdominal free fluid. Twenty-three patients (1.5%) were eventually diagnosed with IBD (19 CD, 4 UC) at gastroenterological follow-up with a median of 60 days (IQR 30–120) from the time of the ED admission. Patients with a future IBD diagnosis were significantly younger (28 vs 51 years, p<0.001) and had higher rates of diarrhea as a presenting symptom (17.4% vs 2.6%, p< 0.001) compared to patients who did not develop IBD. On multivariate analysis, age (p< 0.001(and colitis on imaging (p=0.001) were associated with the development of IBD.

Conclusion

IBD would be eventually diagnosed only in a minority of patients presenting with ileitis or colitis on abdominal CT. Younger age, diarrhea as a presenting symptom and colitis on imaging are predisposing factors.
P201 Crohn’s Disease of the terminal ileum associated with ileo-sigmoid fistula: risk factors for ileostomy formation and postoperative complications during the years of biologics
Authors: Belvedere A , Gerti D , Canavese A , Pulcina G , Romano A , Poggioli G , Rottoli M
Published: January 2022

Background

Ileo-sigmoid fistula (ISF) is a complication of Crohn’s disease occurring in a significant proportion of patients. The aim of this study was to describe the perioperative outcomes of patients affected by ISF and to identify the risk factors for complications and ileostomy formation.

Methods

Consecutive patients operated for ISF between 2004 and 2021 in a single referral centre were included. Considering the presence of a large number of regressors the variables to include in the models were selected using the least absolute shrinkage and selection operator (LASSO) method. The multivariate analyses of the independent variables associated with the risk of ileostomy formation and post-operative complications were conducted using logistic regression.

Results

Of the 208 patients who underwent ileocolic resection for ISF (Table 1), 161 (77.4%) also underwent sigmoid resection, while 47 (22.6%) underwent a conservative treatment of the target sigmoid colon. ISF was detected preoperatively with CT scan in 121 (58%) patients and with colonoscopy in 63 (30%) patients.

Significant risk factors for ileostomy (performed in 63 patients - 30%, Table 2) were the preoperative diagnosis of ISF (Odds Ratio - OR - 2.22, 95% Confidence Interval - CI – 1.02–4.78), surgery for a recurrence (OR 6.71, 95% CI 1.46–30.86), the presence of an intrabdominal abscess (OR 3.03, 95% CI 1.44–6.35), and additional small bowel surgery (OR 2.6, 95% CI 1.08–6.25).

Anastomotic leak occurred in 19 (9%) patients. Postoperative complications classified grade 2 or higher according to Clavien-Dindo (71 patients, 34.1%) were significantly associated with additional small bowel surgery (OR 2.42, 95% CI 1.11–5.3), the presence of an intrabdominal abscess (OR 2.45, 95%CI 1.44–6.35), and the localization of Crohn’s disease to the left colon (OR 1.98, 95%CI 1.03–3.8).

Conclusion

Although a diverting ileostomy was more likely to be performed in those patients identified perioperatively as high-risk subjects (more clinically relevant ISF, recurrent disease, addition bowel surgery or abdominal sepsis), this did not prevent the onset of postoperative complications, which seem to be associated with a more disseminated disease (either to the colon or to other locations of the small bowel) or with the presence of untreated intra-abdominal sepsis.
P219 Impact of COVID-19 pandemic in patients with a first consultation for suspected inflammatory bowel disease
Authors: Ramos Lopez L , Hernández A , Carrillo-Palau M , Hernández-Camba A , Alonso-Abreu I , Reygosa C , Vela M , Rodríguez G E , González-Mendez Y , Tardillo C , Arranz L , Benítez-Zafra F , Hernández-Guerra M
Published: January 2022

Background

During the COVID-19 pandemic, outpatient activity and the performance of complementary tests have been limited in order to optimize health care resources in patients with SARS-CoV2 infection according to the incidence of cases in each time period. The aim of this study was to determine the impact of the measures implemented by the COVID-19 pandemic on the diagnosis, initiation of treatment, and follow-up of patients referred for suspected inflammatory bowel disease (IBD) at different times during the pandemic.

Methods

Retrospective multicenter study comparing three cohorts of patients who were referred for evaluation in IBD consultation during three time periods: pre-pandemic “pre-COVID19” (pC), from March to May 2019; during health alert “alert-COVID19” (aC), from March to May 2020; and during a recent post-pandemic alert period “post-COVID19 alert” (p-aC), from January 2021 to March 2021. All patients referred with suspected IBD (“first time” consultation) were included. Epidemiological and clinical variables were recorded from the onset of digestive symptoms and up to a follow-up of 6 months after consultation.

Results

A total of 114 first-time consultations were recorded: 47 in pC (age 45.3, SD 2.6 years; 63.83% female), 24 in aC (age 48.3, SD 3.3; male 54.2%) and 43 in p-aC (age 44.5, SD 2.4; male 53.4%). Significant differences were determined in terms of the reason for consultation between the periods (recent diagnosis of IBD: 25.5% pC vs 41.7% cD vs 53.5% a-pC; p= 0.03 and suspicion of IBD: 74.5% pC vs 58.3% aC vs 46.5% in p-aC; p = 0.03). The diagnosis of IBD was confirmed in 44.6% of patients in the pC period, 66.6% in aC and 67.4% in p-aC, (p=0.06). There were no significant differences between the three periods in terms of time from suspicion of the disease to evaluation at the first visit and time to completion of complementary tests. However, there were significant differences in the time between diagnosis and initiation of treatment among the pC group (mean 1.7, SD 1.05 months), in contrast to 4.36 months (SD 2.03) in aC and 3.82 months (SD 1.3) in p-aC (p= 0.05). There were also no differences in the management (treatment and request for complementary tests) of the sucessive consultation, except for the number of hospital admissions in the six months following the first consultation (5 cases in pC vs. no admissions in aC and p-aC,p=0.03).

Conclusion

During the COVID19 pandemic,the ability to diagnose patients with IBD has been maintained with no delays in the performance of complementary tests at participating centers. However, a delay in the initiation of treatment that could negatively impact the health of IBD patients is currently being maintained.
P222 Raman Spectroscopy in the diagnosis of pIBD: experimental study
Authors: Viola I , Costa S , Pellegrino S , Acri G , Romano C
Published: January 2022

Background

Diagnostic delay is a major issue among the paediatric Inflammatory Bowel Disease (pIBD) population because of the association with higher risk of complications and growth failure. At present, non-invasive serological and faecal biomarkers lack sufficient sensibility and/or sensitivity to be used as a diagnostic tool in clinical practice and none can discriminate between Crohn’s Disease (CD) and Ulcerative Colitis (UC). In this setting, new non-invasive diagnostic tools with better diagnostic performance are needed.Raman Spectroscopy (RS) is a spectroscopic technique that relies on the inelastic scattering process of monochromatic light. Through the analysis of spectra molecular changes can be identified.The overall objective of this study was to explore RS performance as a non-invasive diagnostic test in IBD diagnosis.

Methods

RS was applied to the analysis of stool protein extracts in pIBD patients and a control group. Being directly in contact with the intestine stool can provide information on the bacterial and inflammatory background and represents an excellent sample material to study. At our Paediatric Gastroenterology Unit 55 patients (age 0–18) were enrolled, 32 cases (20 MC, 2 Very Early Onset-IBD, 9 CU, 2014 Porto criteria), 23 controls (functional constipation, irritable bowel syndrome, Rome IV criteria). Protein extract from faecal samples (obtained by the same kit test used to evaluate faecal calprotectin) were analysed with a DXR- Smart Raman Spectrometer (thermos Fisher Scientific, Waltham, MA, USA) with a 785 nm diode laser. After obtaining a spectrum the analysis focused on the band in the wavenumber range of about 1550–1750 cm-1 which defines the amide-I vibration modes, deconvolution of this band was performed. Ratio of the area of the sub-bands, parameter R, was calculated. Receiver Operating Characteristic (ROC) Curve and Youden Index (J) were used for statistical analysis.

Results

As represented by the ROC curve R showed a great diagnostic accuracy in differentiating between cases and controls, AUC 0,9389 (0,87-1,00) figure 1. A cut-off value of 1,2 distinguished cases from controls with sensibility 0,9 (0,78-0,95), specificity 1 (0,85-1), figure 2.

In the group of cases R distinguished CD from UC, AUC 0,83 (0,65-1) figure 3. A cut of value of 1,4 distinguished CD from UC with sensibility 1 (0,69-1), specificity 0,83 (0,58-0,96) figure 4.

Conclusion

This is the first application of RS as a non-invasive diagnostic tool on stool samples. Preliminary data show that RS may recognize IBD from non-IBD features, and, what is completely new, it can discriminate the two main forms of IBD, CD and UC. Future prospective studies including patients with suspected IBD will help defining the diagnostic performance.
P225 David against Goliath: direct comparison of hand-held bowel sonography and magnetic resonance enterography for diagnosis of Crohn’s disease
Authors: Rispo A , Mainenti P P , Testa A , de Sire R , Imperatore N , Nardone O M , Ricciolino S , Patturelli M , Olmo O , Calabrese G , Castiglione F
Published: January 2022

Background

The diagnosis of small bowel Crohn’s disease (CD) is mainly performed by ileo-colonoscopy (IC), while the assessment of its extension can be achieved non-invasively by using magnetic resonance enterography (MRE) and bowel sonography (BS) in view of a very concordant agreement about diagnostic accuracy. More recently, hand-held sonography has been used effectively in cardiological and orthopaedical diagnostic settings, while data about its use for CD diagnosis are still scarce. The aim of this pilot study was to evaluate the diagnostic accuracy of hand-held BS (HHBS) in comparison with MRE for the diagnosis of CD.

Methods

From September 2019 to June 2021, we prospectively studied 85 consecutive subjects who attended our third level IBD Unit for suspected CD. All patients underwent IC (as gold standard for CD diagnosis), HHBS (VScan, dual probe, 5–7.5 MHz; General Elelectric®) and MRE in a random order and blind way. MRE was assumed as reference standard for defining the extension of small bowel CD. Bivariate correlation about CD extension between MRE and HHBS was calculated by Spearman’s coefficient (r). To test the consistency between MRE and HHBS for CD location and complications (strictures, abscesses, fistulas) the Cohen’s k measure was applied. A p value of 0.05 was considered significant.

Results

The diagnosis of small bowel CD was made in 48 out of 85 subjects (56%), whereas the remaining 37 subjects received a different diagnosis. Sensitivity, specificity, positive and negative predictive values for CD diagnosis were 87% (95%CI 74–95%), 91% (95%CI 78–98%), 91% (95%CI 78–96%), 88% (95%CI 77–93%) for HHBS (TP 42, TN 34, FP 3, FN 6) and 92% (95%CI 80–97%), 95% (95%CI 81–99%), 94% (95%CI 81–98%), 91% (95%CI 85–97%) for MRE (TP 44, TN 35, FP 2, FN 4), without significant differences (p=N.S.). On the other hand, MRE was superior to HHBS in defining CD extension (r=0.67; p<0.01) and location (k = 0.81; p<0.01). Also, MRE showed a better diagnostic performance than HHBS for detecting strictures (k=0.75; p<0.01), abscesses (k=0.68; p<0.01) and fistulas (k=0.65; p<0.01).

Conclusion

HHBS and MRE are two accurate and non-invasive procedures for the diagnosis of CD, even if MRE appears to be more sensitive in defining the extension, location and intestinal complications. HHBS could be used as effective ambulatory (or out-of-office) screening tool for selecting the patients to submit to MRE examination because of high probability of CD diagnosis.
P231 Emergency Colectomy for IBD Is Not Associated with Increased Risk of Postoperative Infection, Reoperation or Readmission
Authors: Connelly T , Clancy C , Cheong J Y , Jia X , Kessler H , Valente M , Holubar MD- MS S
Published: January 2022

Background

The current literature suggests that IBD patients have worse outcomes after emergency surgery when compared to elective surgery. We hypothesized that this association will be lost after matching cohorts of emergency and elective patients. We aimed to confirm the current emergency IBD surgery literature in a large cohort of unmatched IBD patients. We then aimed to determine if postoperative outcomes are worse in matched patients undergoing elective vs emergency colectomy.

Methods

We utilized the NSQIP PUF IBD Cohort 2005–2019 to assess 30-day outcomes in adult IBD patients undergoing emergency vs elective colectomy. Our primary outcome was any complication. Our secondary endpoints were readmission, reoperation, and mortality. Univariable and multivariable logistic regression models were used to examine the association between emergency surgery and complications in the unmatched cohort. Propensity-score matching was performed to match emergency patients to non-emergency patients on a 1:1 basis. A logistic regression model was used to assign a propensity score to each patient using emergency surgery as the outcome. All preoperative and perioperative characteristics were included in the model except those with > 20% missing data. The probability of emergency surgery based on these factors was used as the propensity score. A greedy matching algorithm was used to find the best controls matches for each case. A Love plot was used to show the covariate balance. Conditional logistic regression were used to evaluate the association between outcomes and emergency surgery on the matched sample.

Results

A total of 16,790 patients (15,849 elective, 941 emergency) were included in the unmatched cohort analysis. 30-day outcomes in 21 categories including length of stay, surgical site infection, sepsis, death and cardiovascular, renal and thrombotic complications were worse in the emergency cohort (Table 1). After matching, 632 sets were constructed. The majority of adverse outcomes demonstrated in the unmatched cohort lost significance. Only unplanned intubation (OR 2.6, p=.006), >48 hours on a ventilator (OR 2.8, p<.001), septic shock (OR 3.6, p<.001) and any complication (OR 1.3, p=.03) retained significance (Table 2).

Conclusion

In concordance with the current literature, we demonstrated increased rates of postoperative infection, cardiovascular and renal complications, reoperation and length of stay in unmatched groups of IBD patients undergoing emergency vs elective surgery. However, the majority of these complications were not significantly different after propensity matching. This suggests that emergency surgery is not associated with poorer outcomes in terms of length of stay, mortality and most morbidities as previously thought.
P236 Interobserver reliability of the Nancy index for ulcerative colitis: An assessment of the practicability and ease of use in a single-centre real-world setting
Authors: Le H D , Pflaum T , Sari S , Bretschneider F , Nikolaus S , Lassen A , Schreiber S , Aden K , Roecken C
Published: January 2022

Background

Histological disease severity assessment in ulcerative colitis has become a mainstay in clinical endpoints definition (“histologic remission”) in clinical trials of ulcerative colitis (UC). Among the several scores that were developed for the microscopical assessment of disease activity, the Nancy index (NI) stands out for the least amount of work load due to the lowest number of scoring items. To which extent histologic assessment using NI is affected by interobserver reliability in the real word setting, is poorly understood. We therefore performed a single-center retrospective analysis of NI assessment in patients with ulcerative colitis.

Methods

We retrospectively evaluated in two independent cohorts with a total of n=1085 of biopsy samples (sigmoid, rectum) taken from 547 clinically diagnosed UC patients, who underwent colonoscopy between 2007 and 2020. Cohort #1 consisted of 637 biopsies from 312 patients, Cohort #2 consisted of 448 biopsies from 235 patients. The NI of these samples were assessed by two blinded pathologists with a different amount of pathological experience. After each cohort a consensus conference was held where samples that were rated with different NI grades were re-assessed, and a consensual score was given by both observers. We evaluated interobserver reliability and differences in the amount of the several grades of the NI rated by the observers.

Results

The interobserver-agreement of the NI was very-good after the assessment of the 1085 samples (κ = 0,687 [95%-CI: 0,653-0,720]). An improvement of the interobserver-agreement was found with growing numbers of samples evaluated by both observers (1st cohort: κ = 0,659 [95%-CI: 0,615-0,704]; 2nd cohort: κ = 0,726 [95%-CI: 0,675-0,776]). The biggest number of differences were in NI grade 1 (observer 1: n=128; observer 2: n=236). The smallest number of differences were in NI grades 0 (observer 1: n=504; observer 2: n=479) and 3 (observer 1: n=71; observer 2: n=66). After a consensual score was given the largest part of grades were NI grade 0 (n=504) followed by NI grade 2 (n=309). The least number of samples were given NI grade 3 (n=62). Average time for scoring was less than 2 minutes.

Conclusion

The NI represents an easy-to-use index with very high interobserver reliability to assess the histological disease activity of UC patients in a real-world setting. Though further improvements of the NI regarding stricter classifications of the several grades need to be done to improve the practicability of the index. While NI grades 0 and 3 having a very high level of agreement between the observers, NI grade 1 has a lower agreement-level. This highlights the clinical need to specify histological characteristic leading to NI grade 1.
P241
Authors: Cifù A , Marino M , Sablich R , Carletti M , Blasone N , Milloch S , Curcio F , Fabris M
Published: January 2022

Background

In recent decades, biological drugs targeting anti-tumour necrosis factor-α (TNF-α) have represented the cornerstone in the treatment of inflammatory bowel diseases. Currently, anti- TNF-α represents a breakthrough in patient care. However, 20–50% of patients experience primary or secondary loss of response. This may be due to pharmacodynamic and/or pharmacokinetic issues, resulting in subtherapeutic drug concentrations, frequently related to the development of anti-drug antibodies (ADA).

In this context, therapeutic drug monitoring (TDM) is essential to patients’ management in order to pinpoint the basis of reduced efficacy. Indeed, a fast and reliable assessments of TDM is mandatory to allow rapid intervention, to avoid toxicity and improve treatment efficacy.

In this study we assess the analytical performance of a novel fully automated chemiluminescent assay in measuring biological drugs levels and ADA serum concentration and to compare its performances to the current diagnostic method (ELISA).

Methods

Serum levels of biological drugs (Infliximab and Adalimumab) and their respective ADA were measured in twenty infliximab (IFX)-treated IBD patients and twenty adalimumab (ADL)-treated IBD patients using both the Promonitor® ELISA kits (Grifols) and the i-TRACKER chemiluminescent (CLIA) kits (Theradiag

Results

The CLIA method is a random-access platform that allows the continuous loading of samples, while the ELISA is a time-consuming manual method to be planned in advance to reduce expenses. Actually, in our laboratory is performed only twice a month. A very good correlation was observed both for Infliximab (Spearman r=0.9695, 95%CI = 0,92-0,99, p<0.0001) and Adalimumab serum levels (Spearman r=0.9476, 95%CI = 0,86-0,98, p<0.0001). Among the patients with undetectable IFX serum levels, 6/8 (75%) resulted ADA positive by ELISA versus 8/8 (100%) by CLIA. Moreover, CLIA disclosed very high ADA concentration in 3 samples compared to borderline results by ELISA. Regarding ADL, all the 9 patients with undetectable serum levels presented similar ADA concentration as tested with ELISA or CLIA.

Conclusion

In conclusion, the i-TRACKER CLIA Infliximab and Adalimumab assays showed a very good correlation for serum-based drugs level quantification as compared to the related ELISA methods. Furthermore, a good agreement was observed for ADA analysis, with a higher sensitivity against anti-IFX antibodies by CLIA compared to ELISA. Our data clearly highlighted that a fully automated assay for TDM would certainly reduce costs and significantly improve the management of IBD patients in terms of a shorter turn-around time.
P257 The clinical decision support tool has low performance in predicting outcome to ustekinumab in Crohn’s disease
Authors: Alsoud D , Sabino J , Ferrante M , Verstockt B , Vermeire S
Published: January 2022

Background

Several biologicals and small molecules have been added to the therapeutic arsenal of inflammatory bowel disease, which generated a wide interest in precision medicine. In this context, both clinical features and laboratory tests have shown some correlation with therapy outcome. Recently, an online clinical decision support tool1 (CDST) was built, using clinical and biochemical variables (e.g. disease location, prior anti-TNF exposure), to help physicians predict the outcome of various biological treatments in Crohn’s disease (CD). We sought to evaluate the predictive performance of this tool in patients with CD initiating ustekinumab (UST).

Methods

Baseline data were collected from consecutive CD patients who started UST IV induction followed by eight weekly UST 90 mg SC maintenance from December 2015 through March 2021 at our referral center. The probability of achieving clinical remission (low, intermediate, or high) was determined using the online CDST using patients’ data. Also, differences in rates of primary non-response and ustekinumab persistence were compared between CDST classifications. Primary non-response was defined as failing to attain endoscopic response (≥50% decrease in SES-CD) nor clinical response (a drop in the physician global assessment score or patients reported outcome), both assessed at month 6 after UST initiation. Finally, we studied the relation between the individual components used to construct the CDST and the three classifications in a univariate analysis.

Results

A total of 291 CD patients started UST, of whom 237 had objectively-assessed (CRP, fCal, symptoms or endoscopy) baseline disease activity. Using the CDST, the proportion of patients with “low”, “intermediate” or “high” probability to attain clinical remission were 11.8 % (n=28), 55.7 % (n=132) and 32.5 % (n=77), respectively. The CDST could not discriminate patients with primary non-response (p value = 0.18; Figure 1), nor identify trends in drug persistence (p value = 0.44; Figure 2). In the univariate analysis, 3 out of 9 components (active fistulizing disease, disease location and concomitant immunomodulatory use) were not significantly contributing to the CDST classification (Table 1).

Conclusion

The recently developed clinical decision support tool showed low performance in predicting short-term (primary clinical and endoscopic response) and long-term (drug persistence) real-life outcomes in CD patients starting UST. These findings underscore the necessity of incorporating molecular variables, in addition to clinical ones, to construct reliable and reproducible tools to predict therapeutic outcomes.

1. https://via.juxlyapps.com/pathway/archemedx/ibd-cdst/index.html#/disease-selection
P264 Prevalence and predictors of stoma formation and restoration of intestinal continuity in patients with Crohn’s disease in a tertiary referral hospital: A retrospective explorative study
Authors: Primas C , Waldhör T , Kozbial K , Dawoud C , Riss S , Reinisch W , Niapri M , Kutschera M , Kazemi-Shirazi L , Reinisch S , Dabsch S , Pedarnig N , Angermann H , Novacek G
Published: January 2022

Background

Crohn’s disease (CD) is associated with a high risk of intestinal complications such as stricture, fistula and abscess formation, as well as perianal disease, frequently requiring surgical procedures and intestinal stoma formation. The aim of the present study was to evaluate the prevalence as well as predictors for surgical stoma formation in CD patients.

Methods

This is a retrospective single tertiary center cohort study of 1157 patients with CD with a median follow-up of 15 years whose characteristics (Table 1) are recorded via a validated data software (IBDIS, Inflammatory Bowel Disease Information System). The primary objective was the assessment of risk factors for intestinal stoma formation during follow-up. The probability of stoma-free survival was calculated for the entire patient population and for subgroups defined by their time of diagnosis (-1999, 2000–2009, 2010-), location and behavior of disease, presence of perianal disease (ever), gender, and smoking habits by means of Kaplan-Meier estimates.

Results

135 (11.7%) patients with intestinal stomas [78 (57.8%) ileostomies and 57 (42.2%) colostomies] were registered. The probability of stoma-free survival after 5, 10, and 20 years was 95.9%, 91.8%, and 85.5%, respectively. Stoma formation surgery was elective in 51 (37.8%) cases, emergency in 49 (36.3%) and unknown in the others (25.9%). The most common indications were perianal disease [(n=34; 25.2%), internal fistula/abscess [n=25 (18.5%)], postoperative complications [n=21 (15.6%)], stricture [n=11 (8.1%)], and refractory to treatment [n=10 (7.4%)]. The probability of stoma-free survival was significantly lower in patients with perianal disease (p<0.0001) (Figure 1), colon involvement (p<0.0001) (Figure 2), and penetrating disease behavior (p<0.0001) (Figure 3). Time of diagnosis, gender, and smoking habit were not significantly associated with stoma-free survival. In 73 (54.1%) patients a restorative surgery for intestinal continuity was performed.

Conclusion

We found a high prevalence of intestinal stoma formation in CD patients of a tertiary center. Patients with perianal disease, penetrating behavior and colonic location, have a lower probability of stoma-free survival.