Outcomes and endpoints of postoperative recurrence in Crohn's Disease: systematic review and consensus conference.
Biotherapy
Clinical trials
IBD
Surgery
Treatment
Journal
Journal of Crohn's & colitis
ISSN: 1876-4479
Titre abrégé: J Crohns Colitis
Pays: England
ID NLM: 101318676
Informations de publication
Date de publication:
19 Dec 2023
19 Dec 2023
Historique:
received:
18
09
2023
medline:
19
12
2023
pubmed:
19
12
2023
entrez:
19
12
2023
Statut:
aheadofprint
Résumé
Outcomes after ileocolonic resection in Crohn's Disease (CD) are heterogeneous and a clear definition of postoperative recurrence remains to be determined. Our Endpoints Working Group of the International Organization for the study of Inflammatory Bowel Disease (IOIBD) aimed to standardize postoperative outcomes, to discuss which endpoints should be used for postoperative clinical trials and to define those which could be used in trials or registries. Based on a systematic review of the literature, recommendations and statements were drafted and sent to all IOIBD members for a first round of voting. Recommendations and statements were revised based on the voters' comments during a consensus hybrid conference open to all IOIBD members. If no agreement was reached after 2 rounds of voting, the statement was excluded. In the systematic review, 3,071 manuscripts were screened, of which 434 were included. Sixteen recommendations were identified, of which 11 were endorsed. Recommendations and statements include that endoscopy remains the gold standard and should be used as a short-term primary endpoint in both observational cohorts and randomized controlled trials. Clinical symptoms classically used in clinical trials for luminal CD are not reliable in this specific situation. For that reason, longer term endpoints should be based on the evidence of macroscopic inflammation assessed by imaging techniques, endoscopy or reflected by the presence of complications. Agencies recommend the use of clinical evaluations, as in the case of luminal CD, and do not recognize primary endpoints based solely on endoscopy. This consensus has led to agreement on the need to define postoperative endoscopy- and/or imaging-based endpoints.
Sections du résumé
BACKGROUND
BACKGROUND
Outcomes after ileocolonic resection in Crohn's Disease (CD) are heterogeneous and a clear definition of postoperative recurrence remains to be determined. Our Endpoints Working Group of the International Organization for the study of Inflammatory Bowel Disease (IOIBD) aimed to standardize postoperative outcomes, to discuss which endpoints should be used for postoperative clinical trials and to define those which could be used in trials or registries.
METHODS
METHODS
Based on a systematic review of the literature, recommendations and statements were drafted and sent to all IOIBD members for a first round of voting. Recommendations and statements were revised based on the voters' comments during a consensus hybrid conference open to all IOIBD members. If no agreement was reached after 2 rounds of voting, the statement was excluded.
RESULTS
RESULTS
In the systematic review, 3,071 manuscripts were screened, of which 434 were included. Sixteen recommendations were identified, of which 11 were endorsed. Recommendations and statements include that endoscopy remains the gold standard and should be used as a short-term primary endpoint in both observational cohorts and randomized controlled trials. Clinical symptoms classically used in clinical trials for luminal CD are not reliable in this specific situation. For that reason, longer term endpoints should be based on the evidence of macroscopic inflammation assessed by imaging techniques, endoscopy or reflected by the presence of complications.
CONCLUSIONS
CONCLUSIONS
Agencies recommend the use of clinical evaluations, as in the case of luminal CD, and do not recognize primary endpoints based solely on endoscopy. This consensus has led to agreement on the need to define postoperative endoscopy- and/or imaging-based endpoints.
Identifiants
pubmed: 38112601
pii: 7478410
doi: 10.1093/ecco-jcc/jjad205
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© The Author(s) 2023. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.