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The bowel preparation for magnetic resonance enterography in patients with Crohn's disease: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Adequate bowel preparation is required for magnetic resonance enterography (MRE), which can be achieved by administering contrast solution after mid-gut tubing or taking contrast solution orally. We present the design of randomized controlled trial (RCT) to compare the efficacy and compliance of bowel preparation between mid-gut tubing and oral administering for MRE in patients with Crohn's disease (CD). METHODS/DESIGN:This is an open-label, multicenter RCT. Ninety-six patients with CD in need of MRE examination and mid-gut tubing (prepared for fecal microbiota transplantation and/or enteral nutrition), aged ??14?years, will be included. Patients will be randomized 1:1 into either bowel preparation by oral administering (oral group) or bowel preparation through mid-gut transendoscopic enteral tubing (TET) (tubing group). The primary outcome measures are: (1) degree of discomfort before/during/after bowel preparation for MRE using a visual 5-grade scale (1?=?few, 5?=?very severe); and (2) grade of bowel distention evaluated by a 5-grade scale (1?=?0-20% segmental distention, 2?=?20-40% distention, 3?=?40-60% distention, 4?=?60-80% distention, 5?=?80-100% distention). The secondary outcome measure is the accuracy of lesion detection through MRE confirmed by colonoscopy which is evaluated by a 5-point scale. DISCUSSION:The outcome of this study is expected to provide a novel effective clinical protocol of bowel preparation for MRE in patients with CD. We hope to highlight the concept of physician-patient satisfaction based on different methods of bowel preparation for MRE. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03541733 . Registered on 30 May 2018.

SUBMITTER: Dai M

PROVIDER: S-EPMC6318891 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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The bowel preparation for magnetic resonance enterography in patients with Crohn's disease: study protocol for a randomized controlled trial.

Dai Min M Zhang Ting T Li Qianqian Q Cui Bota B Xiang Liyuan L Ding Xiao X Rong Rong R Bai Jianling J Zhu Jianguo J Zhang Faming F

Trials 20190103 1

<h4>Background</h4>Adequate bowel preparation is required for magnetic resonance enterography (MRE), which can be achieved by administering contrast solution after mid-gut tubing or taking contrast solution orally. We present the design of randomized controlled trial (RCT) to compare the efficacy and compliance of bowel preparation between mid-gut tubing and oral administering for MRE in patients with Crohn's disease (CD).<h4>Methods/design</h4>This is an open-label, multicenter RCT. Ninety-six ...[more]

PMID: 30606236

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Project description:BackgroundThis study aimed to construct a magnetic resonance imaging (MRI) index for assessing transmural inflammatory activity in the small intestine of patients with Crohn' disease which enables rapid and non-invasive quantitative assessment of Crohn's disease inflammation.MethodsIn this prospective study, magnetic resonance enterography (MRE) was performed to examine 29 consecutive patients with Crohn's disease who had undergone ileocolonoscopy in the Jingling hospital of Nanjing. This diagnostic study was not registered on a clinical trial platform. We grade the T2 signal ratio and T1 enhancement ratio with a score of 0 to 3. The ratios were calculated as follow: terminal ileal inflammation of intestinal T2 signal intensity/adjacent normal intestinal T2 signal intensity (T2 ratio 1), terminal ileal inflammation intestinal T2 signal intensity/vertical muscle T2 signal intensity (T2 ratio 2), the fifth phase of the inflamed intestinal T1 signal intensity/noncontrast intestine T1 signal (T1 ratio 3), and the fifth phase of inflamed intestinal T1 signal intensity/adjacent normal intestinal T1 signal (T1 ratio 4). Wall thickness, lymph nodes, perimural T2 signal, comb sign, and ulceration were graded from 0 to 3. the simple endoscopic score for Crohn's disease (SES-CD) from 0 to 12 was used to assess Crohn's disease activity as a reference. The study calculated the correlations between the MRE activity index and endoscopic activity scores and derived the MRE index model to assess Crohn's disease activity.ResultsThe MRE index model (a T1 ratio 4 score of 1.52 + an ulceration score of 2.03) had a sensitivity of 0.962, a specificity of 0.667, and an area under the curve (AUC) of 0.968 [95% confidence interval (CI): 0.921-1.000]. The intraclass correlation coefficient (ICC) for the interobserver agreement of the MRE index was 0.921 (95% CI: 0.833-0.963).ConclusionsThe study derived an MRE index with good sensitivity to inflammatory changes in the small bowel. The index could be used to assess Crohn's disease activity of the small bowel.

Project description:ObjectivesTo compare patient acceptability and burden of magnetic resonance enterography (MRE) and ultrasound (US) to each other, and to other enteric investigations, particularly colonoscopy.Methods159 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.ResultsOverall, 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.ConclusionsMRE 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:BackgroundMagnetic 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.MethodsWe 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.Findings284 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.InterpretationBoth 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.FundingNational Institute of Health and Research Health Technology Assessment.

Dataset Information

The bowel preparation for magnetic resonance enterography in patients with Crohn's disease: study protocol for a randomized controlled trial.

Publications

The bowel preparation for magnetic resonance enterography in patients with Crohn's disease: study protocol for a randomized controlled trial.

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