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Surveillance in inflammatory bowel disease: white light endoscopy with segmental re-inspection versus dye-based chromoendoscopy – a multi-arm randomised controlled trial (HELIOS)
  1. Maarten te Groen1,
  2. Anouk M Wijnands2,
  3. Nathan den Broeder1,
  4. Dirk J de Jong1,
  5. Willemijn A van Dop1,
  6. Marjolijn Duijvestein1,
  7. Herma H Fidder2,
  8. Fiona van Schaik2,
  9. Meike M C Hirdes2,
  10. Andrea E van der Meulen-de Jong3,
  11. P W Jeroen Maljaars3,
  12. Philip W Voorneveld3,
  13. K H Nanne de Boer4,
  14. Charlotte P Peters5,
  15. Bas Oldenburg2,
  16. Frank Hoentjen1,6
  17. Dutch Initiative on Crohn and Colitis
  1. 1 Inflammatory Bowel Disease Centre, Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The Netherlands
  2. 2 Inflammatory Bowel Disease Centre, Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, The Netherlands
  3. 3 Inflammatory Bowel Disease Centre, Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, The Netherlands
  4. 4 Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism Research Institute, Vrije Universiteit Amsterdam, Amsterdam University Medical Centres, Amsterdam, The Netherlands
  5. 5 Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam University Medical Centers, Amsterdam, The Netherlands
  6. 6 Division of Gastroenterology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada
  1. Correspondence to Dr Frank Hoentjen; hoentjen{at}ualberta.ca

Abstract

Background It remains unclear if the increased colorectal neoplasia detection rate in inflammatory bowel disease (IBD) by high-definition (HD) dye-based chromoendoscopy compared with HD white-light endoscopy is due to enhanced contrast or increased inspection times. Longer withdrawal times may yield similar neoplasia detection rates as found by HD chromoendoscopy.

Objective To compare colorectal neoplasia detection rates for HD white-light endoscopy with segmental re-inspection and HD chromoendoscopy, using single-pass HD white-light endoscopy as an additional control group.

Design In a multicentre, randomised controlled trial, IBD patients aged ≥18 years without active disease and scheduled for endoscopic surveillance were included. Patients were 2:2:1 randomised to HD white-light endoscopy with segmental re-inspection of each colonic segment (double pass), HD chromoendoscopy or single-pass HD white-light endoscopy. The primary outcome was colorectal neoplasia detection rate. Assuming equal colorectal neoplasia rates (non-inferiority margin of 10%) between segmental re-inspection and chromoendoscopy and superiority of segmental re-inspection vs single-pass HD white-light endoscopy, a sample size of 566 patients was required.

Results In total, 563 patients were analysed per-protocol. Colorectal neoplasia detection rates were 10.3% (n=24/234) for HD white-light endoscopy with segmental re-inspection and 13.1% (n=28/214) for HD chromoendoscopy. This confirmed non-inferiority to HD chromoendoscopy (Δ−2.8%, lower limit 95% CI −7.8, p<0.01). In addition, the number of detected colorectal neoplasia per 10 min of withdrawal time was similar between HD white-light endoscopy with segmental re-inspection and HD chromoendoscopy (0.062 vs 0.058, p=0.83). Single-pass HD white-light endoscopy yielded a lower colorectal neoplasia rate (6.1%; n=7/115) than segmental re-inspection but this was not statistically significant (Δ4.1%, 95% CI −2.2:9.6%, p=0.19).

Conclusions HD white-light endoscopy with segmental re-inspection was non-inferior to HD chromoendoscopy for colorectal neoplasia detection in IBD patients. It can therefore be assumed that the benefit of HD chromoendoscopy may be explained by the longer withdrawal time and not necessarily the enhanced contrast. However, re-inspection per se did not lead to a significantly higher colorectal neoplasia rate than single-pass HD white-light endoscopy alone.

  • INFLAMMATORY BOWEL DISEASE
  • ENDOSCOPY
  • SURVEILLANCE

Data availability statement

Data are available upon reasonable request. The data that support the findings of this study are available on request from the corresponding author [F.H].

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Data availability statement

Data are available upon reasonable request. The data that support the findings of this study are available on request from the corresponding author [F.H].

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Footnotes

  • MtG and AMW are joint first authors.

  • BO and FH are joint senior authors.

  • X @mtegroen

  • Collaborators Dutch Initiative on Crohn and Colitis.

  • Contributors MG and AMW: conceptualisation, methodology, formal analysis, investigation, data curation, writing – original draft, visualisation, project administration. NB: methodology, formal analysis. DJ, WAD, MD, HHF, FDMS, MMCH, PWJM and PWV: investigation, writing – review and editing. AEM, KHNB and CPP: investigation, resources, writing – review and editing. BO and FH: conceptualisation, methodology, investigation, resources, writing – review and editing, supervision, funding acquisition. FH is the guarantor. BO and FH are shared last authorship.

  • Funding Supported by the Dutch Initiative on Crohn and Colitis and the “StichtingInnovatie en Kwaliteit Maag, Darm-, Leverziekten” (Tilburg, The Netherlands) (AMW).

  • Competing interests Marjolijn Duijvestein has received a speaking fee from Bristol Meyers Squibb, Takeda, Galapagos, served in an advisory board for Abbvie, Bristol Meyers Squibb, Celltrion, Galapagos, Janssen, Takeda and has received Grant/Research support from Pfizer, Bristol Meyers Squibb, Galapagos and Janssen. Andrea van der Meulen has received independent research funding from Nestle, Norgine, Cablon, Galapagos and has served on advisory boards for Tramedico, Janssen, Takeda, Galapagos, Vedanta, Ferring, Abbvie and Dear Health. Nanne de Boer has served as a speaker for AbbVie and MSD and has served as a consultant and principal investigator for TEVA Pharma BV and Takeda. He has received a research grant (unrestricted) from Dr. Falk, TEVA Pharma BV, Dutch Digestive Foundation (MLDS) and Takeda. All outside the submitted work. Frank Hoentjen has served on advisory boards or as speaker for Abbvie, Janssen, MSD, Takeda, Pfizer, Celltrion, Teva, Sandoz, Amgen and Pendopharm, and has received independent research funding from Janssen, Abbvie, Pfizer and Takeda. Bas Oldenburg has received research funding from Galapagos, Takeda, Ferring, Abbvie and BMS. He served on advisory boards or as speaker for Ferring, Abbvie, Takeda, Janssen, Galapagos, Celltrion and Pfizer. The remaining authors diclose no conflicts.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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