Prospective Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Dec 14, 2017; 23(46): 8235-8247
Published online Dec 14, 2017. doi: 10.3748/wjg.v23.i46.8235
Efficacy of noninvasive evaluations in monitoring inflammatory bowel disease activity: A prospective study in China
Jin-Min Chen, Tao Liu, Shan Gao, Xu-Dong Tong, Fei-Hong Deng, Biao Nie
Jin-Min Chen, Shan Gao, Xu-Dong Tong, Department of Gastroenterology, Xiangyang Central Hospital, Hubei University of Arts and Science, Xiangyang 441021, Hubei Province, China
Tao Liu, Department of Gastroenterology, the Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou 510665, Guangdong Province, China
Fei-Hong Deng, Guangdong Provincial Key Laboratory of Gastroenterology, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, Guangdong Province, China
Biao Nie, Department of Gastroenterology, the First Affiliated Hospital of Jinan University, Jinan University, Guangzhou 510630, Guangdong Province, China
Author contributions: Chen JM and Nie B designed the study and wrote the manuscript; Deng FH collected fecal and blood samples and completed patient case report; Liu T and Nie B performed all endoscopies and completed the endoscopic scoring sheet; Tong XD quantified fecal calprotectin; Gao S performed data analysis; all authors read and approved the final manuscript.
Supported by National Natural Science Foundation of China to Biao Nie, No. 81471080.
Institutional review board statement: The study was reviewed and approved by the institutional review board of Department of Gastroenterology in Nanfang Hospital (Guangzhou, China) and the Medical Ethnic Committee of Nanfang Hospital (NFEC-2014-065).
Clinical trial registration statement: The clinical trial was registered in Chinese Clinical Trial Registry (registration ID: ChiCTR-DDT-14005066). Details can be found at http://www.chictr.org.cn/showproj.aspx?proj=4509.
Informed consent statement: All study participants provided written informed consent prior to study enrollment.
Conflict-of-interest statement: The authors of this manuscript have no conflicts of interest to disclose.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at email: niebiao2@163.com. Participants gave informed consent for data sharing.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Biao Nie, MD, PhD, Professor, Associate Chief Physician, Department of Gastroenterology, the First Affiliated Hospital of Jinan University, Jinan University, No. 614, West Huangpu Avenue, Guangzhou 510630, Guangdong Province, China. niebiao2@163.com
Telephone: +86-15101503392 Fax: +86-20-38688025
Received: July 31, 2017
Peer-review started: August 1, 2017
First decision: September 6, 2017
Revised: September 28, 2017
Accepted: November 2, 2017
Article in press: November 2, 2017
Published online: December 14, 2017
Abstract
AIM

To optimize the efficacy of noninvasive evaluations in monitoring the endoscopic activity of inflammatory bowel disease (IBD).

METHODS

Fecal calprotectin (FC), clinical activity index (CDAI or CAI), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and procalcitonin (PCT) were measured for 136 IBD patients. Also, FC was measured in 25 irritable bowel syndrome (IBS) patients that served as controls. Then, endoscopic activity was determined by other two endoscopists for colonic or ileo-colonic Crohn’s disease (CICD) with the “simple endoscopic score for Crohn’s disease” (SES-CD), CD-related surgery patients with the Rutgeerts score, and ulcerative colitis (UC) with the Mayo score. The efficacies of these evaluations to predict the endoscopic disease activity were assessed by Mann-Whitney test, χ2 test, Spearman’s correlation, and multiple linear regression analysis.

RESULTS

The median FC levels in CD, UC, and IBS patients were 449.6 (IQR, 137.9-1344.8), 497.9 (IQR, 131.7-118.0), and 9.9 (IQR, 049.7) μg/g, respectively (P < 0.001). For FC, CDAI or CAI, CRP, and ESR differed significantly between endoscopic active and remission in CICD and UC patients, but not in CD-related surgery patients. The SES-CD correlated closely with levels of FC (r = 0.802), followed by CDAI (r = 0.734), CRP (r = 0.658), and ESR (r = 0.557). The Mayo score also correlated significantly with FC (r = 0.837), CAI (r = 0.776), ESR (r = 0.644), and CRP (r = 0.634). For FC, a cut-off value of 250 μg/g indicated endoscopic active inflammation with accuracies of 87.5%, 60%, and 91.1%, respectively, for CICD, CD-related surgery, and UC patients. Moreover, clinical FC activity (CFA) calculated as 0.8 × FC + 4.6 × CDAI showed higher area under the curve (AUC) of 0.962 for CICD and CFA calculated as 0.2 × FC + 50 × CAI showed higher AUC (0.980) for UC patients than the FC. Also, the diagnostic accuracy of FC in identifying patients with mucosal inflammation in clinical remission was reflected by an AUC of 0.91 for CICD and 0.96 for UC patients.

CONCLUSION

FC is the most promising noninvasive evaluation for monitoring the endoscopic activity of CICD and UC. CFA might be more accurate for IBD activity evaluation.

Keywords: Inflammatory bowel disease, Crohn’s disease, Ulcerative colitis, Fecal calprotectin, Disease activity

Core tip: This was a prospective study conducted in China to assess the efficacy of noninvasive markers, including fecal calprotectin, clinical activity index (CDAI or CAI), CRP, ESR, and procalcitonin (PCT) for monitoring disease activity in colonic or ileo-colonic Crohn’s disease (CICD), CD-related surgery patients, and UC patients and further to optimize the accuracy of those noninvasive biomarkers in detecting active residual mucosal inflammation in IBD patients in clinical remission.