More than 20 procedures are necessary to learn small bowel capsule endoscopy: Learning curve pilot study of 535 trainee cases.

Background and study aims The number of procedures needed to acquire a sufficient level of skills to perform an unassisted evaluation of small bowel capsule endoscopy (SBCE) is unknown. We aimed to establish learning curves, diagnostic accuracy, and the number of procedures needed for reviewing small bowel capsule endoscopies unassisted. Methods An expert panel developed a 1-day course including lessons (examination, anatomy, and pathology) and hands-on training. After completing the course, participants received 50 cases in a randomized sequence. An interactive questionnaire about landmarks, findings, and diagnosis followed each case. After submitting the questionnaire, participants received feedback. Data are presented using CUSUM (cumulative sum control chart) learning curves and sensitivity/specificity analyses compared with expert opinions. Results We included 22 gastroenterologists from 11 different Danish hospitals. A total of 535 cases were reviewed (mean: 28; range: 11-50). CUSUM plots demonstrated learning progression for diagnosis and findings during the course, but none of the participants reached a learning plateau with sufficient competencies. The sensitivity for all findings was 65% (95% confidence interval [CI] 0.51-0.82) for the first 20 procedures and 67% (95% CI 0.58-0.73) from case 21 until completion or dropout. The specificity was 63% (95% CI 0.52-0.74) for the first 20 procedures and 57% (95% CI 0.37-0.77) for the rest. Conclusions Our data indicate that learning SBCE may be more difficult than previously recognized due to low discriminative abilities after 20 cases except for the identification of CD. This indicates that 20 SBCE cases may not be sufficient to achieve competency for reviewing SBCE without supervision.

Novel biomarker profiles to improve individual diagnosis and prognosis in patients with suspected inflammatory bowel disease: protocol for the Nordic inception cohort study (NORDTREAT).

INTRODUCTION: Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, can be challenging to diagnose, and treatment outcomes are difficult to predict. In the NORDTREAT cohort study, a Nordic prospective multicentre study, we aim to identify novel molecular biomarkers of diagnostic value by assessing the diagnostic test accuracy (cross-sectionally), as well as the prognostic utility when used as prognostic markers in the long-term (cohort study). In the diagnostic test accuracy study, the primary outcome is a successful diagnosis using one or more novel index tests at baseline compared with the ECCO criteria as the reference standard. The composite outcome of the prognostic utility study is 'severe IBD' within 52 weeks from inclusion, defined as one or more of the following three events: IBD-related surgery, IBD-related hospitalisation or IBD-related death. METHODS AND ANALYSIS: We aim to recruit 800 patients referred on suspicion of IBD to this longitudinal observational study, a collaboration between 11 inclusion sites in Denmark, Iceland, Norway and Sweden. Inclusion will occur from February 2022 until December 2023 with screening and baseline visits for all participants and three outcome visits at weeks 12, 26 and 52 after baseline for IBD-diagnosed patients. Biological material (blood, faeces, biopsies, urine and hair), clinical data and lifestyle information will be collected during these scheduled visits. ETHICS AND DISSEMINATION: This study will explore novel biomarkers to improve diagnostic accuracy and prediction of disease progression, thereby improving medical therapy and the quality of life for patients with IBD.The study is approved by the Ethics Committee (DK: S-20200051, v1.4, 16.10.2021; IS: VSNb2021070006/03.01, NO: 193064; SE: DNR 2021-05090) and the Danish Data Protecting Agency (20/54594). Results will be disseminated through peer-reviewed journals, patient associations and presentations at international conferences. CLINICAL TRIAL REGISTRATION NUMBER: NCT05414578; Pre-results.

Artificial Intelligence-assisted Analysis of Pan-enteric Capsule Endoscopy in Patients with Suspected Crohn's Disease: A Study on Diagnostic Performance.

BACKGROUND AND AIM: Pan-enteric capsule endoscopy [PCE] is a highly sensitive but time-consuming tool for detecting pathology. Artificial intelligence [AI] algorithms might offer a possibility to assist in the review and reduce the analysis time of PCE. This study examines the agreement between PCE assessments aided by AI technology and standard evaluations, in patients suspected of Crohn's disease [CD]. METHOD: PCEs from a prospective, blinded, multicentre study, including patients suspected of CD, were processed by the deep learning solution AXARO® [Augmented Endoscopy, Paris, France]. Based on the image output, two observers classified the patient's PCE as normal or suggestive of CD, ulcerative colitis, or cancer. The primary outcome was per-patient sensitivities and specificities for detecting CD and inflammatory bowel disease [IBD]. Complete reading of PCE served as the reference standard. RESULTS: A total of 131 patients' PCEs were analysed, with a median recording time of 303 min. The AXARO® framework reduced output to a median of 470 images [2.1%] per patient, and the pooled median review time was 3.2 min per patient. For detecting CD, the observers had a sensitivity of 96% and 92% and a specificity of 93% and 90%, respectively. For the detection of IBD, both observers had a sensitivity of 97% and had a specificity of 91% and 90%, respectively. The negative predictive value was 95% for CD and 97% for IBD. CONCLUSIONS: Using the AXARO® framework reduced the initial review time substantially while maintaining high diagnostic accuracy-suggesting its use as a rapid tool to rule out IBD in PCEs of patients suspected of Crohn's disease.

Additional information obtained from mucosal biopsies is limited after pan-enteric capsule endoscopy in patients with suspected Crohn's disease.

Background and study aims Pan-enteric capsule endoscopy (CE) is an emerging alternative to ileo-colonoscopy for diagnosing Crohn's disease (CD). However, CE does not offer the opportunity to take biopsies to support the diagnosis. This study examined the additional information obtained with mucosal biopsies and the feasibility of CE as a single diagnostic procedure. Patients and methods This retrospective study was based on a prospective, blind multicenter trial in which patients with suspected CD were examined with ileo-colonoscopy plus segmental biopsies and CE. Histopathological findings were compared to the result of CE. Results A total of 107 patients with a complete CE were included in the analysis. CE was consistent with CD in 44 patients (41.1%) and ulcerative colitis in 10 patients (9.3%). Histopathology confirmed the result of CE in 39.3% of patients and added new diagnostic information in 6.5% of patients. A CE consistent with CD was histologically confirmed in 20.5% of patients. Biopsies most often showed non-specific inflammation (61.4%). Only one patient with a normal CE had a specific histological diagnosis (microscopic colitis). Biopsies altered the diagnosis of ulcerative colitis to CD in two patients, and in two patients with a normal CE, biopsies showed CD or ulcerative colitis. In one patient with lymphoma in the terminal ileum and cecum, CE was misinterpreted as CD. Conclusions In patients with suspected CD and an evident result of CE, the additional information obtained from biopsies is limited, and CE as a single diagnostic procedure might be feasible in selected patients. Biopsies are warranted, however, in patients with an atypical endoscopic appearance or suspected malignancy.

Intestinal ultrasound in patients with suspected Crohn's disease - results of a prospective evaluation by trainees.

BACKGROUND AND AIMS: Intestinal ultrasound (IUS) performed by experts is a valuable tool for the diagnostic work-up and monitoring of Crohn's disease (CD). However, concern about insufficient training and perceived high inter-observer variability limit the adoption of IUS in CD. We examined the diagnostic accuracy of trainee-performed IUS in patients with suspected CD. METHOD: Patients recruited to a prospective trial investigating the diagnostic accuracy of magnetic resonance enterocolonography (MREC) in patients with clinically suspected CD underwent IUS performed by trainees. The primary end-point was IUS per-patient sensitivity and specificity for ileocolonic CD determined by ileocolonoscopy. RESULTS: 129 patients with clinically suspected CD and a complete IC and IUS were included in the analysis. IUS detected signs of CD in 49 cases (small bowel 31, colon 15, small bowel, and colon 3). The sensitivity and specificity for detection of ileocolonic CD by trainee performed IUS improved during the first to the second half of the study period from 57.1% (CI 34.0-78.2) to 73.1% (CI 52.2-88.4) and 76.5% (CI 58.8-89.3) to 89.7% (CI 72.6-97.8). The overall sensitivity and specificity of diagnosing CD with IUS were 65.4% (CI 50.9-78.0) and 80.5% (CI 69.9-88.7). There was no difference in diagnostic performance between IUS and MREC for the detection of CD. CONCLUSION: Trainees improved during the study, and IUS performance in disease detection corresponded to expert-evaluated MREC.Registered at ClinicalTrials.gov (NCT03134586).

Endoscopic severity and classification of lesions with pan-enteric capsule endoscopy and ileocolonoscopy in ileocolonic Crohn's disease.

Background and study aims Recent evidence supports the use of pan-enteric capsule endoscopy (CE) for the diagnosis and follow-up of Crohn's disease (CD). The aim of this study was to examine the agreement between CE and ileocolonoscopy (IC) for determining the severity and classification of lesions in ileocolonic CD. Patients and methods In a prospective blinded multicenter study, patients with suspected CD were examined with CE and IC within 2 weeks. Ninety-nine participants with a full IC and CE were included in the analysis. The ileocolonic disease severity was assessed with the Simple Endoscopic Score for Crohn's Disease (SES-CD). Results CD was diagnosed in 30 patients with IC and CE. The mean SES-CD was 9.8 (CI 7.9-11.8) and 10.6 (CI 8.2-13.1), respectively ( P  = 0.69). There was a substantial agreement (ICC 0.83, CI 0.68-0.92) and a strong correlation between SES-CD assessed with IC and CE (r s  = 0.78, P  < 0.001). 55 bowel segments had ulcerations with both modalities (terminal ileum 24, right colon 12, transverse colon eight, left colon eight and rectum three). Mean sub-scores for ulcer size, area of ulcerated surface and area of affected surface did not differ between modalities. The inter-modality agreement (κ) was 0.46, 0.34 and 0.43, respectively ( P  < 0.001). Conclusions There is a strong correlation between IC and CE for the severity of ileocolonic CD. The agreement for SES-CD sub-scores is fair to moderate. CE could be an alternative to IC for the assessment of endoscopic severity in selected patients with suspected CD.

Diagnostic accuracy of pan-enteric capsule endoscopy and magnetic resonance enterocolonography in suspected Crohn's disease.

BACKGROUND AND AIMS: Magnetic resonance enterocolonography (MREC) and pan-enteric capsule endoscopy (CE) offers visualization of the entire gastrointestinal tract in a single examination. We examined the diagnostic accuracy of MREC and CE in patients with suspected Crohn's disease (CD). METHOD: In a prospective, blinded, multicenter study, we included patients with clinically suspected CD. Patients were examined with MREC, CE, and ileocolonoscopy (IC) within 2 weeks. The primary outcome was per patient sensitivity, specificity, and diagnostic accuracy for ileocolonic CD. IC served as reference standard. RESULTS: 153 patients were included in the study and IC, MREC, and CE was performed in 152, 151, 133 patients, respectively. CD was diagnosed with IC in 59 (39%) patients (terminal ileum (TI) 22, colon 20, TI and colon 17). The sensitivity and specificity for diagnosing ileocolonic CD with MREC was 67.9% (CI 53.7-80.1) and 76.3% (CI 65.2-85.3) (TI 76.9% and 85.6%; colon 27% and 93%) compared to 87.5% (CI 73.2-95.8) and 87.8% (CI 78.2-94.3) with CE (TI 96.6% and 87.5%; colon 75.0% and 93.0%). The sensitivity of CE was superior to that of MREC (p = 0.02). The patient experienced discomfort was equal with CE and MREC and significantly less than with IC. CONCLUSION: In patients with suspected CD, CE has a high sensitivity for diagnosing CD in the TI and colon, which is superior to that of MREC. The sensitivity of MREC for diagnosing CD in the colon is poor. CE could be a patient-friendly alternative to IC in selected patients with suspected CD. Registered at ClinicalTrials.gov: NCT03134586.

[Collagenous sprue in a patient with severe diarrhoea, malnutrition and acute renal failure].

Collagenous sprue is a rare enteropathy affecting the small intestinal mucosa and can resemble and coincide with coeliac disease or collagenous colitis. To our knowledge, less than 175 cases of collagenous sprue have been described. Both clinicians and pathologists should be aware of the condition in order to adequately target their investigations and treatment. This is a case report of severe collagenous sprue in a 78-year-old male resulting in severe diarrhoea, weight loss, malnutrition and acute kidney failure. The disorder improved on a lactose and gluten-free diet, loperamide and corticosteroids.

Effect of tofacitinib in a patient with inflammatory bowel disease-related arthritis.

Extraintestinal manifestations are common in patients with chronic inflammatory bowel disease (IBD). Peripheral arthritis occurs in ∼10% of patients with IBD. Treatment of both arthritis and the IBD disease is challenging, and involvement of both the rheumatologist and the gastroenterologist is essential. We present a case with concomitant polyarthritis and ulcerative colitis successfully treated with tofacitinib. A 32-year-old woman with ulcerative colitis currently treated with azathioprine and adalimumab was referred to our rheumatology clinic due to pain and swelling in her knees and finger joints. The patient was diagnosed with IBD-related arthritis. Intra-articular injection with steroid was initially effective, but the arthritis was persistent. Treatment attempts with salazopyrine and golimumab were discontinued due to drug-induced pancreatitis and urticaria, respectively. Subsequently treatment with tofacitinib 10 mg twice daily was effective within weeks, and apart from a mild folliculitis, there were no side effects. With this case report, we would like to draw attention to the fact that treatment with tofacitinib may constitute a good treatment option in refractory cases of IBD-related arthritis.

Association Between the Clinical, Biochemical, and Endoscopic Activity of Inflammatory Bowel Diseases and Severity and Long-term Outcomes of Coronavirus Disease 2019-A Population-based Study.

This brief report investigated the impact of clinical, biochemical, and endoscopic activity of IBD on the severity and long-term outcomes of COVID-19 in a prospective population-based cohort. The study did not identify any association between IBD activity and COVID-19 outcomes.

Outcomes and Long-Term Effects of COVID-19 in Patients with Inflammatory Bowel Diseases - A Danish Prospective Population-Based Cohort Study with Individual-Level Data.

BACKGROUND AND AIMS: The health consequences of coronavirus disease 2019 [COVID-19] among patients with ulcerative colitis [UC] and Crohn's disease [CD] remain largely unknown. We aimed to investigate the outcomes and long-term effects of COVID-19 in patients with UC or CD. METHODS: We conducted a prospective, population-based study covering all Danish patients with CD or UC and confirmed COVID-19 between January 28, 2020 and April 1, 2021, through medical records and questionnaires. RESULTS: All 319 patients with UC and 197 patients with CD who developed COVID-19 in Denmark were included in this study and compared with the Danish background population with COVID-19 [N = 230 087]. A significantly higher risk of COVID-19-related hospitalization was observed among patients with UC (N = 46 [14.4%], relative risk [RR] = 2.49 [95% confidence interval, CI, 1.91-3.26]) and CD (N = 24 [12.2%], RR = 2.11 [95% CI 1.45-3.07]) as compared with the background population (N = 13 306 [5.8%]). A similar pattern was observed for admission to intensive care (UC: N = 8 [2.51%], RR = 27.88 [95% CI 13.88-56.00]; CD: N = 3 [1.52%], RR = 16.92 [95% CI 5.46-52.46]). After a median of 5.1 months (interquartile range [IQR] 4.5-7.9), 58 [42.3%] and 39 [45.9%] patients with UC and CD, respectively, reported persisting symptoms which were independently associated with discontinuation of immunosuppressive therapies during COVID-19 (odds ratio [OR] = 1.50 [95% CI 1.07-10.22], p = 0.01) and severe COVID-19 (OR = 2.76 [95% CI 1.05-3.90], p = 0.04), but not with age or presence of comorbidities. CONCLUSION: In this population-based study of 516 patients with IBD and COVID-19, 13.6% needed hospitalization and 2.1% required intensive care. Furthermore, sequelae were frequent, affecting 43.7% of COVID-19-infected patients. These findings might have implications for planning the healthcare of patients in the post-COVID-19 era.

Adherence to the bowel cleansing regimen for pan-enteric capsule endoscopy in patients with suspected Crohn's disease and factors affecting the image quality.

OBJECTIVE: Pan-enteric capsule endoscopy (CE) is an attractive diagnostic approach in patients examined for Crohn's disease (CD). The aim of this study was to examine the adherence to the recommended bowel cleansing regimen and determine clinical factors affecting the image quality. METHODS: In a prospective blinded trial, patients with suspected CD were examined with the PillCam Crohn's capsule after bowel preparation with 2 + 2 L of polyethylene glycol (PEG) and sodium phosphate booster. The image quality was graded on a four-point scale. A good or excellent image quality defined a diagnostic procedure. RESULTS: Fifty-nine patients participated. The mean volume of PEG was 2.5 L (CI 2.3-2.8). Ten patients (17%) were able to drink all 4 L of PEG, and 44 patients (75%) ingested ≥2 L. The image quality was poor, fair, good or excellent in 0%, 29.3%, 29.3% and 41.4%, respectively. The mean volume of PEG was 1.9 L (CI 1.4-2.4), 2.2 L (CI 1.8-2.7) and 3.2 L (CI 2.8-3.5) in patients with a fair, good or excellent image quality (p < .001). In a regression analysis, only the volume of PEG was associated with the obtained image quality (rs=0.52; p < .001). The diagnostic yield was equal in patients with a diagnostic or non-diagnostic procedure (43.9% and 47.1%, respectively). CONCLUSIONS: In patients examined with pan-enteric CE for suspected CD, the volume of PEG is the major factor affecting the image quality. Although few patients are able to ingest the recommended volume, the diagnostic yield is not affected.

A deep learning framework for autonomous detection and classification of Crohn's disease lesions in the small bowel and colon with capsule endoscopy.

Background and study aims Small bowel ulcerations are efficiently detected with deep learning techniques, whereas the ability to diagnose Crohn's disease (CD) in the colon with it is unknown. This study examined the ability of a deep learning framework to detect CD lesions with pan-enteric capsule endoscopy (CE) and classify lesions of different severity. Patients and methods CEs from patients with suspected or known CD were included in the analysis. Two experienced gastroenterologists classified anonymized images into normal mucosa, non-ulcerated inflammation, aphthous ulceration, ulcer, or fissure/extensive ulceration. An automated framework incorporating multiple ResNet-50 architectures was trained. To improve its robustness and ability to characterize lesions, image processing methods focused on texture enhancement were employed. Results A total of 7744 images from 38 patients with CD were collected (small bowel 4972, colon 2772) of which 2748 contained at least one ulceration (small bowel 1857, colon 891). With a patient-dependent split of images for training, validation, and testing, ulcerations were diagnosed with a sensitivity, specificity, and diagnostic accuracy of 95.7 % (CI 93.4-97.4), 99.8 % (CI 99.2-100), and 98.4 % (CI 97.6-99.0), respectively. The diagnostic accuracy was 98.5 % (CI 97.5-99.2) for the small bowel and 98.1 % (CI 96.3-99.2) for the colon. Ulcerations of different severities were classified with substantial agreement (κ = 0.72). Conclusions Our proposed framework is in excellent agreement with the clinical standard, and diagnostic accuracies are equally high for the small bowel and colon. Deep learning approaches have a great potential to help clinicians detect, localize, and determine the severity of CD with pan-enteric CE.

Vedolizumab as first-line biological therapy in elderly patients and those with contraindications for anti-TNF therapy: a real-world, nationwide cohort of patients with inflammatory bowel diseases.

BACKGROUND: Data from real-life populations about vedolizumab as first-line biological therapy for ulcerative colitis (UC) and Crohn's disease (CD) are emerging. OBJECTIVE: To investigate the efficacy and safety of vedolizumab in bio-naïve patients with UC and CD. METHODS: A Danish nationwide cohort study was conducted between November 2014 and November 2019. Primary outcomes were clinical remission, steroid-free clinical remission, and sustained clinical remission from weeks 14 through 52. RESULTS: The study included 56 patients (UC:31, CD:25) who initiated treatment with vedolizumab mainly because of contraindications to anti-TNFs, of whom 54.8 and 24.0%, respectively received systemic steroids at the initiation. Rates of clinical remission at weeks 6, 14, and 52 were 32.0, 48.0, and 40.0%, respectively, in UC, and 36.8, 36.8, and 47.4% in CD. Steroid-free clinical remission at week 52 was achieved among 36.0 and 47.4% of UC and CD patients, while sustained clinical remission was achieved in 32.0 and 36.8%. Lack of remission was associated with being female (68.8 vs. 11.1%, p = .01) in UC and non-structuring, non-penetrating behavior in CD (90.0 vs. 44.4%, p = .03); however, this was not confirmed in multivariate analysis. Discontinuation due to primary non-response occurred in 20.0 and 5.3% of UC and CD patients, respectively, while rates of secondary loss of response were 12.0 and 5.3% after 52 weeks of follow-up. Vedolizumab was well-tolerated as only one UC patient experienced a serious adverse event. CONCLUSION: Vedolizumab is effective in the achievement of short-term, long-term, and steroid-free clinical remission in bio-naïve UC and CD patients.

Serological Assessment of the Quality of Wound Healing Processes in Crohn's Disease.

BACKGROUND AND AIMS: Crohn's disease (CD) is a chronic inflammatory condition characterized by continuous mucosal damage and ongoing wound healing of the intestines. The fibrinolytic system is involved in early parts of the wound healing process. Fibrin is a key mediator of primary blood clot formation and is formed by cross-linking of fibrinogen. To gain insights into the dynamics of wound healing in CD patients we investigated the conversion of fibrinogen into fibrin by the pro-peptide FPA, the amount of factor XIII cross-linked fibrin and total fibrin clot. METHODS: Serum samples of 35 CD patients, 15 non-inflammatory bowel disease (non-IBD) patients and 39 age-matched healthy controls were analyzed for three novel neo-epitope markers: D-fragment and D-dimer, reflecting the degradation of total fibrin clot and factor XIII cross-linked fibrin, as well as FPA, reflecting synthesis of fibrin. RESULTS: Crohn's disease patients had a significantly lower D-dimer level (p=0.0001) compared to healthy controls. Crohn's disease and non-IBD patients had a significantly higher level of FPA (p<0.0001) and D-fragment/D-dimer ratio (p<0.0001 and p=0.02). FPA, D-dimer and D-fragment/D-dimer ratio could distinguish CD patients from healthy controls with area under the curve of 0.92 (95% CI 0.83-0.97), 0.78 (95% CI 0.67-0.87) and 0.85 (95% CI 0.75-0.93), respectively. CONCLUSION: Wound healing parameters were clearly changed in CD patients. FPA levels were higher in CD patients as compared to healthy controls, indicating more ongoing wound healing. D-dimer levels were lower in CD patients than in healthy controls, indicating impaired wound healing due to poor quality of factor XIII cross-linked fibrin and clot resolution.

[CVID is a multifaceted disease].

Common variable immunodeficiency disease (CVID) is the most common primary immunodeficiency in adults, and multiple organs may be involved. This is a case report of a 49-year-old female patient with granulomatous-lymphocytic interstitial lung disease, liver fibrosis, portal hypertension and rectal cancer. Examinations showed non-necrotic granulomas in her lungs, mediastinal glands and liver, and she was seen in six different specialities. The multifaceted manifestation of CVID calls for multidisciplinary collaboration.

Ulcerative colitis, Crohn's disease, and irritable bowel syndrome have different profiles of extracellular matrix turnover, which also reflects disease activity in Crohn's disease.

BACKGROUND: Increased protease activity is a key pathological feature of inflammatory bowel disease (IBD). However, the differences in extracellular matrix remodelling (ECM) in Crohn's disease (CD) and ulcerative colitis (UC) are not well described. An increased understanding of the inflammatory processes may provide optimized disease monitoring and diagnostics. We investigated the tissue remodelling in IBD and IBS patients by using novel blood-based biomarkers reflecting ECM remodelling. METHODS: Five ECM biomarkers (VICM, BGM, EL-NE, C5M, Pro-C5) were measured by competitive ELISAs in serum from 72 CD patients, 60 UC patients, 22 patients with irritable bowel syndrome (IBS), and 24 healthy donors. One-way analysis of variance, Mann-Whitney U-test, logistic regression models, and receiver operator characteristics (ROC) curve analysis was carried out to evaluate the diagnostic accuracy of the biomarkers. RESULTS: The ECM remodelling was significantly different in UC compared to CD. The best biomarker combination to differentiate UC from CD and colonic CD was BGM and VICM (AUC = 0.98, P<0.001; AUC = 0.97, P<0.001), and the best biomarker combination to differentiate IBD from IBS patients were BGM, EL-NE, and Pro-C5 (AUC = 0.8, P<0.001). When correcting for the use of immunosuppressant and elevated CRP levels (CRP>5mg/mL), correlation of Pro-C5 (r = 0.36) with CDAI was slightly improved compared to CRP (r = 0.27) corrected for the use of immunosuppressant. Furthermore, BGM and EL-NE biomarkers were highly associated with colon inflammation in CD patients. CONCLUSION: ECM fragments of tissue remodelling in IBD affect UC and CD differently, and may aid in differentiating IBD from IBS (EL-NE, BGM, Pro-C5), and UC from CD patients (BGM, VICM). Formation of type V collagen is related to the level of inflammation in CD and may reflect disease activity in CD.

Capsule endoscopy for the diagnosis and follow up of Crohn's disease: a comprehensive review of current status.

Capsule endoscopy (CE) has revolutionized the diagnosis and monitoring of small bowel Crohn's disease (CD). The procedure is patient friendly and noninvasive, and compared to cross-sectional imaging, CE allows a direct and detailed evaluation of the entire small bowel mucosa with a high sensitivity for the earliest lesions of CD. Today, CE is the leading modality for visualizing the small bowel in suspected CD, and validated activity indices are available for the follow up of patients with established CD. CE of the entire gastrointestinal tract (panenteric CE) was recently introduced as a new diagnostic approach in patients examined for CD, and preliminary results are promising. There are important limitations, involving mainly capsule retention. Furthermore, a diagnostic criterion for CD has never been validated, and lesions detected by CE are not specific for CD. Hence, concern has been raised about a low specificity compared to other diagnostic modalities. Important questions about the optimal bowel preparation, selection of patients for CE and the optimal reading protocol remain to be clarified. The aim of this review is to evaluate the performance of CE for diagnosing CD and assess disease activity in known CD; to compare the diagnostic accuracy of CE to that of cross-sectional imaging; to discuss limitations; and to define the place of CE in the diagnostic algorithm in suspected or known CD.

The Danish National Registry for Biological Therapy in Inflammatory Bowel Disease.

AIM: The aims of The Danish National Registry for Biological Therapy in Inflammatory Bowel Disease are to ensure that biological therapy and the clinical management of patients with inflammatory bowel disease (IBD) receiving biological treatment are in accordance with the national clinical guidelines and, second, the database allows register-based clinical epidemiological research. STUDY POPULATION: The study population comprises all Danish patients with IBD (both children and adults) with ulcerative colitis, Crohn's disease, and IBD unclassified who receive biological therapy. Patients will be enrolled consecutively when biological treatment is initiated. MAIN VARIABLES: The variables in the database are: diagnosis, time of diagnosis, disease manifestation, indication for biological therapy, previous biological and nonbiological therapy, date of visit, clinical indices, physician's global assessment, pregnancy and breastfeeding (women), height (children), weight, dosage (current biological agent), adverse events, surgery, endoscopic procedures, and radiology. DESCRIPTIVE DATA: Eleven clinical indicators have been selected to monitor the quality of biological treatment. For each indicator, a standard has been defined based on the available evidence. National results will be published in an annual report and local results on a quarterly basis. The indicators will be reported as department-specific proportions with 95% confidence intervals, and the national average will be provided for comparison. An estimated 1,200-1,300 new biological therapies are initiated each year in Danish patients with IBD. CONCLUSION: The database will be available for research during 2016. Data will be made available by The Danish Clinical Registries (www.rkkp.dk).

Symptomatic Patency Capsule Retention in Suspected Crohn's Disease.

The main limitation of capsule endoscopy is the risk of capsule retention. In patients with suspected Crohn's disease, however, this complication is rare, and if a small bowel stenosis is not reliably excluded, small bowel patency can be confirmed with the Pillcam patency capsule. We present two patients examined for suspected Crohn's disease who experienced significant symptoms from a retained patency capsule. Both patients had Crohn's disease located in the terminal ileum. In one patient, the patency capsule caused abdominal pain and vomiting and was visualized at magnetic resonance enterography 9 days after ingestion. Symptoms improved spontaneously. Another patient experienced small bowel perforation with severe peritonitis caused by an intact patency capsule wedged in a small bowel stricture. We conclude that the Pillcam patency capsule is an effective modality for securing small bowel patency prior to capsule endoscopy. However, it should be emphasized that delayed patency capsule degradation and symptomatic capsule retention is a rare but potentially severe complication which should be treated aggressively, either medically or endoscopically.