Last reviewed · How we verify

NCT04291976: HELIOS

Back-to-back Endoscopy Versus Single-pass Endoscopy and Chromoendoscopy in IBD Surveillance

Completed NA Last updated 21 November 2023
What this trial tests

NA trial testing Back-to-back high-definition white light endoscopy in Inflammatory Bowel Diseases in 563 participants. Completed in 7 November 2023.

Timeline
13 March 2020
Primary endpoint
23 May 2023
7 November 2023

Quick facts

Lead sponsorRadboud University Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment563
Start date13 March 2020
Primary completion23 May 2023
Estimated completion7 November 2023
Sites4 locations across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Radboud University Medical Center

Who can join

18 and older, any sex, with Inflammatory Bowel Diseases or Colorectal Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The current international guidelines for CRC surveillance in IBD recommend as first choice the use of chromoendoscopy, and as an alternative high-definition white light endoscopy (HDWLE) for optimal dysplasia detection, based on data from clinical trials. However, data on the superiority of CE over HDWLE are not consistent in literature. The investigators hypothesize that the better performance of CE in some clinical trials is the result of the associated longer procedural time and the fact that every colon segment is examined twice. Currently, no studies have been published evaluating the dysplastic yield of back-to back HDWLE compared to HDWLE with a single pass or CE in patients with IBD. In the present study, the investigators aim to compare the yield of dysplasia/CRC between 1) regular HDWLE, 2) HDWLE back-to-back, and 3) CE.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Inflammatory Bowel Disease and Colorectal Cancer.
    Fanizza J, Bencardino S, Allocca M, Furfaro F, et al · · 2024 · cited 32× · PMID 39272800 · DOI 10.3390/cancers16172943

Verify or expand the search:

Other recruiting trials for Inflammatory Bowel Diseases

Currently open trials in the same condition.

Other Radboud University Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04291976.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing