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NCT04291976: HELIOS
Back-to-back Endoscopy Versus Single-pass Endoscopy and Chromoendoscopy in IBD Surveillance
NA trial testing Back-to-back high-definition white light endoscopy in Inflammatory Bowel Diseases in 563 participants. Completed in 7 November 2023.
23 May 2023
Quick facts
| Lead sponsor | Radboud University Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 563 |
| Start date | 13 March 2020 |
| Primary completion | 23 May 2023 |
| Estimated completion | 7 November 2023 |
| Sites | 4 locations across Netherlands |
Drugs / interventions tested
- Back-to-back high-definition white light endoscopy
- single-pass high-definition white light endoscopy
- chromoendoscopy
Conditions studied
- Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
- Colorectal Neoplasms — all drugs for Colorectal Neoplasms →
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):
-
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:
- PubMed search for NCT04291976
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Radboud University Medical Center trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04291976 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Radboud University Medical Center
- Last refreshed: 21 November 2023
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