Panenteric capsule endoscopy versus ileocolonoscopy plus magnetic resonance enterography in Crohn's disease: a multicentre, prospective study.
ABSTRACT: INTRODUCTION:Crohn's disease diagnosis and monitoring remains a great clinical challenge and often requires multiple testing modalities. Assessing Crohn's disease activity in the entire gastrointestinal (GI) tract using a panenteric capsule endoscopy (CE) system could be used as an alternative to colonoscopy and cross-sectional imaging. This study assessed the accuracy and safety of panenteric CE in Crohn's disease as compared with ileocolonoscopy (IC) and/or magnetic resonance enterography (MRE). METHODS:A prospective, multicentre study was performed in subjects with established Crohn's disease. Individuals with proven small bowel patency underwent a standardised bowel preparation, followed by CE ingestion and IC either the same or following day. MRE, IC, and CE interpretations were performed by blinded central readers using validated scoring systems. The primary endpoint was the overall sensitivity of CE vs MRE and/or IC in Crohn's disease subjects. RESULTS:Study enrolment included 158 subjects from 21 sites in the USA, Austria, and Israel. Of those, 99 were included in the analysis. Imaging modality scores indicated none to mild inflammation in the proximal small bowel and colon, but discrepant levels of inflammation in the terminal ileum. Overall sensitivity for active enteric inflammation (CE vs MRE and/or IC) was 94% vs 100% (p=0.125) and specificity was 74% vs 22% (p=0.001). Sensitivity of CE was superior to MRE for enteric inflammation in the proximal small bowel (97% vs 71%, p=0.021), and similar to MRE and/or IC in the terminal ileum and colon (p=0.500-0.625). There were seven serious adverse advents of which three were related to the CE device. CONCLUSION:Panenteric CE is a reliable tool for assessing Crohn's disease mucosal activity and extent compared with more invasive methods. This study demonstrates high performance of the panenteric CE as compared to MRE and/or IC without the need for multiple tests in non-stricturing Crohn's disease. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov NCT03241368.
Project description:Background and Aims:Diagnostic yield of Small Bowel Capsule Endoscopy (SBCE) for the assessment of small bowel (SB) lesions is higher than radiologic imaging techniques. However, magnetic resonance enterography (MRE) data are scarce and inconclusive. Colon Capsule Endoscopy (CCE) is a new capsule modality. The primary aim of our study was to compare MRE and capsule endoscopy (CE) for the assessment of Crohn's disease (CD). The secondary objectives were to compare the diagnostic accuracy of both CE modalities and changes in Montreal classification after each examination. Methods:We included 47 patients with established (n = 32) or suspected CD (n = 15). MRE was performed first to rule out strictures. In patients with a suspected stricture by MRE, an Agile Patency Capsule was performed. SB disease activity was measured by MaRIA score (MRE) and Lewis Index (CE). Results:SB lesions were found in 36 of47 patients with CE and in 21 of47 patients with MRE (76.6% vs 44.7%, P = 0.001). Jejunal inflammation was detected by CE in 31.9% of patients and by MRE in 6.4% of patients (15/47 vs 3/47; P = 0.03); lesions in ileum were detected in 57.4% of patients by CE, and in 21.3% of patients by MRE (27/ 47 vs 10/ 47; P = 0.04). Finally, in terminal ileum, CE showed lesions in 68.1% (32/47) of patients, whereas MRE detected lesions in 38.3% (18/ 47 patients), (P = 0.001). The original Montreal classification was changed in 53.1% of patients (25/ 47) based on CE findings and in 12.7% of patients (6/47) based on MRE findings (P < 0.05). Conclusions:In our cohort CE was significantly superior to MRE for detecting SB lesions, mainly superficial and proximal lesions. CE is useful for a appropriate patients' classification according to Montreal classification.
Project description:BACKGROUND:Magnetic resonance enterography (MRE) and wireless capsule endoscopy (WCE) are equally accepted modalities for noninvasive screening of small bowel involvement (SBI) in children with Crohn's disease (CD) and indeterminate colitis (IC) albeit there is a paucity of data comparing the two and thereby guiding the clinician in selecting the ideal diagnostic approach. Therefore, the goal of this study is to provide additional evidence for capsule endoscopy role in the evaluation of established Crohn's disease exacerbation compared to MRE in relation to Pediatric Crohn's Disease Activity Index (PCDAI), and histological indices. AIM:To prospectively compare the findings of MRE and WCE and their agreement with PCDAI or histology in children with CD or IC. METHODS:Consecutive patients diagnosed with CD and IC were screened for inclusion. After informed consent, patient's demographic and clinical data was abstracted. The current pediatric disease activity index (PCDAI) and endoscopic findings were included. Patients underwent MRE and WCE including preprocedural patency capsule within a maximum of 7 d of each other. Pathological presence of active small bowel disease in ileal and duodenal biopsies were collected if the endoscopy was performed within 2 mo of the WCE study. Patients who failed to pass the PC were excluded from the study. WCE was read by two different experienced gastroenterologists (Attard TM and Colombo JM) blinded to each other's findings and to the findings on MRE (Mardis NJ). Agreement between WCE reviewers, WCE and MRE findings and concordance between positive PCDAI and SBI based on MRE compared with WCE was computed. RESULTS:Forty-five patients were included in the study, 18 withdrew and 27 (20 males and 20 CD), mean age (standard deviation) 13.46 (2.4) years, completed the study protocol. There were no instances of capsule retention. Concordance between gastroenterologist reviewers was excellent for the diagnosis of small intestinal CD with good correlation between the two Lewis scores (r = 0.875, P < 0.001). Concordance between WCE and MRE was poor (69%). In CD patients, when both MRE and WCE were compared using PCDAI > 10 as the standard reference reflecting active small intestinal CD, the sensitivity of MRE and WCE were 100% and 83% respectively and the specificity of MRE and WCE were 57.14% and 78.6%, respectively. If the histology in ileum or/and duodenum was used as the reference for active small bowel involvement, WCE had a higher specificity as compared to MRE (83.3% vs 50%). In patients with Crohn's disease, those with a positive PCDAI (> 10) were more likely to have a positive WCE as compared to those with a negative PCDAI (83% vs 21%; P = 0.018). CONCLUSION:We suggest that MRE and WCE have a complementary role in the assessment of SBI in CD. WCE detected SBI with a much higher specificity while MRE had a higher sensitivity.
Project description:Aims:Wireless capsule endoscopy (WCE) and magnetic resonance enterography (MRE) are increasingly utilized to evaluate the small bowel (SB) in Crohn's disease (CD). The primary aims were to compare the ability of WCE and MRE to detect SB inflammation in children with newly diagnosed CD, and in the terminal ileum (TI) to compare them to ileo-colonoscopy. Secondary aims were to compare diagnostic accuracy of WCE and MRE and changes in Paris classification after each study. Methods:Patients (10 to 17 years of age) requiring ileo-colonoscopy for suspected CD were invited to participate. Only patients with endoscopic/histologic evidence of CD underwent MRE and WCE. SB inflammation and extent were documented and comparative analyses performed. Results:Of 38 initially recruited subjects, 20 completed the study. WCE and MRE were similarly sensitive in identifying active TI inflammation (16 [80%] versus 12 [60%]) and any SB inflammation (17 [85%] versus 16 [80%]). However, WCE detected more extensive SB disease than MRE with active inflammation throughout the SB in 15 [75%] versus 1 [5%] patient (P < 0.001). Moreover, WCE was more likely to detect proximal SB disease (jejunum and ileum) compared to MRE (85% versus 50%, P = 0.04). Overall, the Paris classification changed in 65% and 85% of patients following MRE and WCE, respectively. Conclusions:WCE is as sensitive as MRE for identifying active TI inflammation, but appears more sensitive in identifying more proximal SB inflammation. In the absence of concern regarding stricturing or extra-luminal disease WCE can be considered for the evaluation of suspected SB CD.
Project description:BACKGROUND AND AIMS: The diagnostic yield of capsule endoscopy (CE) compared with magnetic resonance imaging (MRI) in small bowel Crohn's disease is not well established. We prospectively investigated CE, MRI, and double contrast fluoroscopy in patients with suspected small bowel Crohn's disease. METHODS: Fifty two consecutive patients (39 females, 13 males) were investigated by MRI, fluoroscopy and--if bowel obstruction could be excluded--by CE. In 25, Crohn's disease was newly suspected while the diagnosis of Crohn's disease (non-small bowel) had been previously established in 27. RESULTS: Small bowel Crohn's disease was diagnosed in 41 of 52 patients (79%). CE was not accomplished in 14 patients due to bowel strictures. Of the remaining 27 patients, CE, MRI, and fluoroscopy detected small bowel Crohn's disease in 25 (93%), 21 (78%), and 7 (of 21; 33%) cases, respectively. CE was the only diagnostic tool in four patients. CE was slightly more sensitive than MRI (12 v 10 of 13 in suspected Crohn's disease and 13 v 11 of 14 in established Crohn's disease). MRI detected inflammatory conglomerates and enteric fistulae in three and two cases, respectively. CONCLUSION: CE and MRI are complementary methods for diagnosing small bowel Crohn's disease. CE is capable of detecting limited mucosal lesions that may be missed by MRI, but awareness of bowel obstruction is mandatory. In contrast, MRI is helpful in identifying transmural Crohn's disease and extraluminal lesions, and may exclude strictures.
Project description:Despite differences in the information obtained by capsule endoscopy (CE) and magnetic resonance enterography (MRE), one of these modalities is usually needed when evaluating disease activity. There are no data on patients' preference that would help guide the choice between these two modalities in these instances.To compare patients' tolerance and preference to MRE versus CE.Patients with known small bowel Crohn's disease (CD) in clinical remission (Crohn's disease activity index [CDAI] <150) or with mild symptoms (CDAI <220) were prospectively recruited. All patients underwent MRE followed by CE. Patients were asked to fill out a questionnaire addressing specific points regarding inconvenience during the preparation for the procedures, the procedures, and postprocedures. Side effects and procedure preference were addressed. Questionnaires were included for analysis only when more than 95% of the items were addressed.Fifty-six patients fulfilled inclusion criteria. Pre-exam discomfort, during-exam discomfort, nausea, vomiting, bloating, and abdominal pain were all significantly more prominent in MRE as compared to CE (P<0.0001, P<0.0001, P<0.0001, P=0.009, P=0.0002, P<0.0001, respectively). MRE was perceived as a more difficult procedure (P<0.0001). Furthermore, MRE was associated with a specific adverse event - claustrophobia. Seventy-eight percent of patients (44 patients) preferred to repeat CE as compared to 22% (P<0.0001) who preferred MRE.CE was better tolerated by CD patients compared to MRE and was preferred by 78% of patients. The superior tolerability of CE should be considered along with the diagnostic features, and more data sought when choosing between these two modalities for CD patients for long-term follow-up.
Project description:To prospectively examine the feasibility and accuracy of Contrast Enhanced Ultrasound (CEUS) in the assessment of Crohn's disease (CD) activity in the terminal ileum in comparison to Magnetic Resonance Enterography (MRE), using endoscopy as a reference standard.105 consecutive patients with alleged clinically active CD were assessed by MRE and CEUS. CEUS of the terminal ileum was performed using an intravenous microbubble contrast enhancer. Accuracy values of CEUS and MRE for the presence of active terminal ileitis were evaluated using the Receiver Operating Characteristic method, using endoscopic findings as a reference standard. Sensitivity and specificity values of MRE and CEUS were compared by the McNemar test.CEUS was feasible in 98% of patients, MRE in all. Optimal diagnostic accuracy in CEUS was obtained at a peak intensity value of 10%, showing 100% sensitivity, 92% specificity and an accuracy of 99% in demonstrating ileal mucosal inflammation. For MRE, overall sensitivity, specificity and accuracy were, 87%, 100%, and 88%, respectively. CEUS and MRE were highly correlated in assessing length and wall thickness of the terminal ileum. CEUS identified 11 of 16 MRE-detected strictures, but no fistulae.The accuracy of CEUS is comparable to that of MRE in the assessment of active, uncomplicated terminal ileal CD and therefore a valuable bedside alternative to MRE in the follow-up of these patients.
Project description:Early recognition of Crohn's disease with initiation of disease-modifying therapy has emerged as a prominent inflammatory bowel disease management strategy. Clinical practice and trials have often focused on patient symptoms, and more recently, serologic tests, stool inflammatory markers, and/or endoscopic inflammatory features for study entry criteria, treatment targets, disease activity monitoring, and to assess therapeutic response. Unfortunately, patient symptoms do not correlate well with biological disease activity, and endoscopy potentially misses or underestimates disease extent and severity in small bowel Crohn's disease. Computed tomography enterography and magnetic resonance enterography (MRE) are potential tools to identify and quantify transmural structural damage and disease activity in the small bowel. In this review, we discuss the role of computed tomography enterography and MRE in disease management algorithms in clinical practice. We also compare the currently developed MRE-based scoring systems, their strengths and pitfalls, as well as the role for MRE in clinical trials for Crohn's disease.
Project description:<h4>Objective</h4>To prospectively evaluate the performance of diffusion-weighted imaging (DWI) to monitor bowel inflammation after medical therapy for Crohn's disease (CD).<h4>Materials and methods</h4>Before and following 1-2 years of medical therapy, between October 2012 and May 2015, 18 randomly selected adult CD patients (male:female, 13:5; mean age ± SD, 25.8 ± 7.9 years at the time of enrollment) prospectively underwent MR enterography (MRE) including DWI (b = 900 s/mm<sup>2</sup>) and ileocolonoscopy. Thirty-seven prospectively defined index lesions (one contiguous endoscopy-confirmed inflamed area chosen from each inflamed anatomical bowel segment; 1-4 index lesions per patient; median, 2 lesions) were assessed on pre- and post-treatment MRE and endoscopy. Visual assessment of treatment responses on DWI in 4 categories including complete remission and reduced, unchanged or increased inflammation, and measurements of changes in apparent diffusion coefficient (?ADC), i.e., pre-treatment-post-treatment, were performed by 2 independent readers. Endoscopic findings and CD MRI activity index (CDMI) obtained using conventional MRE served as reference standards.<h4>Results</h4>?ADC significantly differed between improved (i.e., complete remission and reduced inflammation) and unimproved (i.e., unchanged or increased inflammation) lesions: mean ± SD (× 10<sup>-3</sup> mm<sup>2</sup>/s) of -0.65 ± 0.58 vs. 0.06 ± 0.15 for reader 1 (<i>p</i> = 0.022) and -0.68 ± 0.56 vs. 0.10 ± 0.26 for reader 2 (<i>p</i> = 0.025). DWI accuracy for diagnosing complete remission or improved inflammation ranged from 76% (28/37) to 84% (31/37). A significant negative correlation was noted between ?ADC and ?CDMI for both readers with correlation coefficients of -0.438 and -0.461, respectively (<i>p</i> < 0.05).<h4>Conclusion</h4>DWI is potentially a feasible tool to monitor quantitatively and qualitatively bowel inflammation of CD after medical treatment.
Project description:OBJECTIVES:To compare patient acceptability and burden of magnetic resonance enterography (MRE) and ultrasound (US) to each other, and to other enteric investigations, particularly colonoscopy. METHODS:159 patients (mean age 38, 94 female) with newly diagnosed or relapsing Crohn's disease, prospectively recruited to a multicentre diagnostic accuracy study comparing MRE and US completed an experience questionnaire on the burden and acceptability of small bowel investigations between December 2013 and September 2016. Acceptability, recovery time, scan burden and willingness to repeat the test were analysed using the Wilcoxon signed rank and McNemar tests; and group differences in scan burden with Mann-Whitney U and Kruskal-Wallis tests. RESULTS:Overall, 128 (88%) patients rated MRE as very or fairly acceptable, lower than US (144, 99%; p < 0.001), but greater than colonoscopy (60, 60%; p < 0.001). MRE recovery time was longer than US (p < 0.001), but shorter than colonoscopy (p < 0.001). Patients were less willing to undergo MRE again than US (127 vs. 133, 91% vs. 99%; p = 0.012), but more willing than for colonoscopy (68, 75%; p = 0.017). MRE generated greater burden than US (p < 0.001), although burden scores were low. Younger age and emotional distress were associated with greater MRE and US burden. Higher MRE discomfort was associated with patient preference for US (p = 0.053). Patients rated test accuracy as more important than scan discomfort. CONCLUSIONS:MRE and US are well tolerated. Although MRE generates greater burden, longer recovery and is less preferred than US, it is more acceptable than colonoscopy. Patients, however, place greater emphasis on diagnostic accuracy than burden. KEY POINTS:• MRE and US are rated as acceptable by most patients and superior to colonoscopy. • MRE generates significantly greater burden and longer recovery times than US, particularly in younger patients and those with high levels of emotional distress. • Most patients prefer the experience of undergoing US than MRE; however, patients rate test accuracy as more importance than scan burden.
Project description:Magnetic resonance enterography (MRE) and ultrasound are used to image Crohn's disease, but their comparative accuracy for assessing disease extent and activity is not known with certainty. Therefore, we did a multicentre trial to address this issue.We recruited patients from eight UK hospitals. Eligible patients were 16 years or older, with newly diagnosed Crohn's disease or with established disease and suspected relapse. Consecutive patients had MRE and ultrasound in addition to standard investigations. Discrepancy between MRE and ultrasound for the presence of small bowel disease triggered an additional investigation, if not already available. The primary outcome was difference in per-patient sensitivity for small bowel disease extent (correct identification and segmental localisation) against a construct reference standard (panel diagnosis). This trial is registered with the International Standard Randomised Controlled Trial, number ISRCTN03982913, and has been completed.284 patients completed the trial (133 in the newly diagnosed group, 151 in the relapse group). Based on the reference standard, 233 (82%) patients had small bowel Crohn's disease. The sensitivity of MRE for small bowel disease extent (80% [95% CI 72-86]) and presence (97% [91-99]) were significantly greater than that of ultrasound (70% [62-78] for disease extent, 92% [84-96] for disease presence); a 10% (95% CI 1-18; p=0·027) difference for extent, and 5% (1-9; p=0·025) difference for presence. The specificity of MRE for small bowel disease extent (95% [85-98]) was significantly greater than that of ultrasound (81% [64-91]); a difference of 14% (1-27; p=0·039). The specificity for small bowel disease presence was 96% (95% CI 86-99) with MRE and 84% (65-94) with ultrasound (difference 12% [0-25]; p=0·054). There were no serious adverse events.Both MRE and ultrasound have high sensitivity for detecting small bowel disease presence and both are valid first-line investigations, and viable alternatives to ileocolonoscopy. However, in a national health service setting, MRE is generally the preferred radiological investigation when available because its sensitivity and specificity exceed ultrasound significantly.National Institute of Health and Research Health Technology Assessment.