Evidence map›Paper›PMID 35689453›Full record

Trial reportJournal of Crohn's & colitis2022

Non-invasive Serological Monitoring for Crohn's Disease Postoperative Recurrence.

Amy L Hamilton, Peter De Cruz, Emily K Wright, Thierry Dervieux, Anjali Jain, Michael A Kamm

Registry-linked trialOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Journal of Crohn's & colitis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00989560 (Post-Operative Crohn's Disease Endoscopic Recurrence "POCER" Study), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
3.0field-weighted citation impact, top 8% 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.

NCT00989560 phase3completednot on this map

Post-Operative Crohn's Disease Endoscopic Recurrence "POCER" Study: Endoscopic Guided Therapeutic Intervention & Determination of Cause

TypeinterventionalSponsorUniversity of MelbourneRan2009 to 2013Enrolled175ConditionsCrohn's DiseaseArmsendoscopy
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 17 citations in OpenAlex.

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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 2 institutions in 2 countries.

Amy L HamiltonDepartment of Gastroenterology, St Vincent's Hospital and Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.ORCID 0000-0002-1627-2057
Peter De CruzDepartment of Gastroenterology, St Vincent's Hospital, Department of Gastroenterology, Austin Health and Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.
Emily K WrightDepartment of Gastroenterology, St Vincent's Hospital and Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.
Thierry DervieuxPrometheus Laboratories, San Diego, CA, USA.
Anjali JainPrometheus Laboratories, San Diego, CA, USA.
Michael A KammDepartment of Gastroenterology, St Vincent's Hospital and Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.
The University of Melbourne · AUPrometheus Biosciences (United States) · US

Funding

Australasian Gastro Intestinal Research FoundationNational Health and Medical Research CouncilPOCER
6 · The paper itself

Abstract

introductionCrohn's disease recurs after intestinal resection. This study evaluated accuracy of a new blood test, the Endoscopic Healing Index [EHI], in monitoring for disease recurrence.

methodsPatients enrolled in the prospective POCER study [NCT00989560] underwent a postoperative colonoscopic assessment at 6 [2/3 of patients] and 18 months [all patients] following bowel resection, using the Rutgeerts score [recurrence ≥i2]. Serum was assessed at multiple time points for markers of endoscopic healing using the EHI, and paired with the Rutgeerts endoscopic score as the reference standard.

resultsA total of 131 patients provided 437 serum samples, which were paired with endoscopic assessments available in 94 patients [30 with recurrence] at 6 months and 107 patients [44 with recurrence] at 18 months. The median EHI at 6 months was significantly lower in patients in remission [Rutgeerts <i2] than those with recurrence; p = 0.033. The area under the receiver operating curve [AUROC] for EHI to detect recurrence at 6 months was comparable to that of faecal calprotectin [0.712 vs 0.779, p = 0.414]. EHI of <20 at 6 months had a negative predictive value of 75.7% (95% confidence interval [CI] 58.8-88.2), and sensitivity of 70% [95% CI 50.6-85.3] for detecting recurrence. Combining all time points, an EHI <20 had a negative predictive value of 70.3%. Changes in EHI significantly associated with changes in Rutgeerts scores over the 18 months.

conclusionsThe non-invasive multi-marker EHI has sufficient accuracy to be used to monitor for postoperative Crohn's disease recurrence. A monitoring strategy that combines EHI with ileocolonoscopy, with or without faecal calprotectin, should now be prospectively tested.

Indexed as

Crohn DiseaseBiomarkersColonoscopyFecesHumansIleumLeukocyte L1 Antigen ComplexProspective StudiesRecurrenceBiomarkersLeukocyte L1 Antigen ComplexCrohn’s diseasedisease monitoringmucosal healingpostoperative recurrenceserology

Identifiers

PMID35689453
PMCPMC9721459
OpenAlexW4282923830

What OpenQuestion holds

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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.