Evidence map›Paper›PMID 32499275›Full record

Trial reportBMJ open gastroenterology2020

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

Registry-linked trialOpen access · goldAbstract readClinical TrialComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03241368 (Multicenter, Prospective, Study Comparing PillCam® Crohn's Capsule Endoscopy), which is not on this map. Cited by 36 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 2 pooled it
7.2field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03241368 nacompletednot on this map

Multicenter, Prospective, Study Comparing PillCam® Crohn's Capsule Endoscopy (CE) to Ileocolonoscopy (IC) Plus MRE for Detection of Active Crohn's Disease (CD) in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease

TypeinterventionalSponsorMedtronic - MITGRan2017 to 2019Enrolled187ConditionsCrohn DiseaseArmsCapsule Endoscopy
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 71 citations in OpenAlex.

  1. Pooled it
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  7. Observational
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  19. Is Panenteric PillcamDiagnostics (Basel, Switzerland) · 2023
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 2 countries.

David Henry BruiningDepartment of Internal Medicine, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA bruining.david@mayo.edu.ORCID 0000-0003-4320-8429
Salvatore OlivaPediatric Gastroenterology and Liver Unit, Maternal and Child Health Department, Sapienza, University of Rome, Rome, Italy.
Mark R FleisherBorland-Groover Clinic, Jacksonville, Florida, USA.
Monika FischerDepartment of Internal Medicine, Indiana University-Purdue University Indianapolis, Indianapolis, Indiana, USA.
Joel G FletcherDepartment of Radiology, Mayo Clinic, Rochester, Minnesota, USA.
BLINK study group
Mayo Clinic · USBorland Groover Clinic · USSapienza University of Rome · ITUniversity of Indianapolis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCrohn'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).

methodsA 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.

resultsStudy 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.

conclusionPanenteric 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.

Indexed as

AdultAustriaCapsule EndoscopyColonoscopyCrohn DiseaseFemaleHumansIleumIntestine, SmallIsraelMagnetic Resonance ImagingMaleMiddle AgedMultimodal ImagingProspective StudiesReproducibility of ResultscolonoscopyCrohn's diseaseendoscopyinflammatory bowel diseasesmall bowel disease

Identifiers

PMID32499275
PMCPMC7282309
OpenAlexW3033054641

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.