Panenteric capsule endoscopy versus ileocolonoscopy plus magnetic resonance enterography in Crohn's disease: a multicentre, prospective study

David Henry Bruining, Salvatore Oliva, Mark R Fleisher, Monika Fischer, Joel G Fletcher, BLINK study group, Linda Cummings, Mukund Venu, Laurel Fisher, Tuba Esfandyari, Kara De Felice, Michael Chiorean, Dario Sorrentino, David Pound, Felix Tiongco, Stanley Cohen, Michael Rice, Pramod Malik, Jack DiPalma, Razvan Arsenescu, Brian Garvin, Carl Raczkowski, Abraham Eliakim, Cristina Carretero Ribon, Leung Wai-Keung, Bruno Rosa, Cristiano Spada, Mattitiahu Waterman, Daniel Mishkin, Blair Lewis, Jordi Rimola, Rendon Nelson, Werner Dolak, David Henry Bruining, Salvatore Oliva, Mark R Fleisher, Monika Fischer, Joel G Fletcher, BLINK study group, Linda Cummings, Mukund Venu, Laurel Fisher, Tuba Esfandyari, Kara De Felice, Michael Chiorean, Dario Sorrentino, David Pound, Felix Tiongco, Stanley Cohen, Michael Rice, Pramod Malik, Jack DiPalma, Razvan Arsenescu, Brian Garvin, Carl Raczkowski, Abraham Eliakim, Cristina Carretero Ribon, Leung Wai-Keung, Bruno Rosa, Cristiano Spada, Mattitiahu Waterman, Daniel Mishkin, Blair Lewis, Jordi Rimola, Rendon Nelson, Werner Dolak

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.

Keywords: Crohn's disease; colonoscopy; endoscopy; inflammatory bowel disease; small bowel disease.

Conflict of interest statement

Competing interests: DHB declares consulting for Medtronic. SO declares research funding from Medtronic.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow chart of the subjects included and excluded in the study. MRE, magnetic resonance enterography; PSB, proximal small bowel; TI, terminal ileum.
Figure 2
Figure 2
(A–D) Subject with active disease in the terminal ileum by MRE (MaRIA score 15.74) and negative findings according to both CE and IC (SES-CD of 0 in the terminal ileum and colon). (A) and (B) demonstrate normal CE and IC images. (C) and (D) demonstrate MRE images of the terminal ileum. After review of all images and laboratory data, the consensus panel determined that the terminal ileum did not have active inflammatory Crohn’s disease. CE, capsule endoscopy; IC, ileocolonoscopy; MaRIA, Magnetic Resonance Index of Activity; MRE, magnetic resonance enterography; SES-CD, Simple Endoscopic Score for Crohn’sDisease.

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