Article Text

Original research
Linked Colour imaging for the detection of polyps in patients with Lynch syndrome: a multicentre, parallel randomised controlled trial
  1. Britt B S L Houwen1,
  2. Yark Hazewinkel2,
  3. María Pellisé3,4,
  4. Liseth Rivero-Sánchez4,5,
  5. Francesc Balaguer4,5,
  6. Raf Bisschops6,
  7. Sabine Tejpar7,
  8. Alessandro Repici8,9,
  9. D Ramsoekh10,
  10. Maarten A J M Jacobs10,
  11. Ramon-Michel M Schreuder11,
  12. Michal Filip Kaminski12,13,
  13. Maria Rupinska12,13,
  14. Pradeep Bhandari14,
  15. Martijn G H van Oijen15,
  16. Lianne Koens16,
  17. Barbara A J Bastiaansen1,
  18. Kristien M Tytgat1,
  19. Paul Fockens1,
  20. Jasper L A Vleugels1,
  21. E Dekker1
  1. 1 Gastroenterology and Hepatology, Amsterdam UMC Location AMC, Amsterdam, North Holland, The Netherlands
  2. 2 Gastroenterology and Hepatology, Radboud University Hospital Nijmegen, Nijmegen, Gelderland, The Netherlands
  3. 3 Gastroenterology, Hospital Clinic de Barcelona, Barcelona, Catalunya, Spain
  4. 4 Gastroenterology, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona, Barcelona, Spain
  5. 5 Gastroenterology, Hospital Clinic de Barcelona, Barcelona, Spain
  6. 6 Gastroenterology, University Hospital Leuven, Leuven, Belgium
  7. 7 Gastroenterology and Hepatology, University Hospital Leuven, Leuven, Belgium
  8. 8 Department of Biomedical Sciences, Humanitas University, Milan, Italy
  9. 9 IRCCS Humanitas Research Hospital, Milan, Italy
  10. 10 Gastroenterology and Hepatology, Amsterdam UMC Location VUMC, Amsterdam, The Netherlands
  11. 11 Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, The Netherlands
  12. 12 Department of Gastroenterology, Hepatology and Oncology, Medical Centre fo Postgraduate Education, Warsaw, Poland
  13. 13 Department of Gastroenterological Oncology, The Maria Sklodowska-Curie Memorial Cancer Centre, Institute of Oncology, Warsaw, Poland
  14. 14 Gastroenterology, Portsmouth Hospitals NHS Trust, Portsmouth, UK
  15. 15 Medical Oncology, Amsterdam UMC Location AMC, Amsterdam, North Holland, The Netherlands
  16. 16 Department of Pathology, Amsterdam UMC Location AMC, Amsterdam, North Holland, The Netherlands
  1. Correspondence to Dr E Dekker, Gastroenterology and Hepatology, Amsterdam UMC Location AMC, Amsterdam, North Holland, The Netherlands; e.dekker{at}amsterdamumc.nl

Abstract

Objective Despite regular colonoscopy surveillance, colorectal cancers still occur in patients with Lynch syndrome. Thus, detection of all relevant precancerous lesions remains very important. The present study investigates Linked Colour imaging (LCI), an image-enhancing technique, as compared with high-definition white light endoscopy (HD-WLE) for the detection of polyps in this patient group.

Design This prospective, randomised controlled trial was performed by 22 experienced endoscopists from eight centres in six countries. Consecutive Lynch syndrome patients ≥18 years undergoing surveillance colonoscopy were randomised (1:1) and stratified by centre for inspection with either LCI or HD-WLE. Primary outcome was the polyp detection rate (PDR).

Results Between January 2018 and March 2020, 357 patients were randomised and 332 patients analysed (160 LCI, 172 HD-WLE; 6 excluded due to incomplete colonoscopies and 19 due to insufficient bowel cleanliness). No significant difference was observed in PDR with LCI (44.4%; 95% CI 36.5% to 52.4%) compared with HD-WLE (36.0%; 95% CI 28.9% to 43.7%) (p=0.12). Of the secondary outcome parameters, more adenomas were found on a patient (adenoma detection rate 36.3%; vs 25.6%; p=0.04) and a colonoscopy basis (mean adenomas per colonoscopy 0.65 vs 0.42; p=0.04). The median withdrawal time was not statistically different between LCI and HD-WLE (12 vs 11 min; p=0.16).

Conclusion LCI did not improve the PDR compared with HD-WLE in patients with Lynch syndrome undergoing surveillance. The relevance of findings more adenomas by LCI has to be examined further.

Trial registration number NCT03344289.

  • colonic polyps
  • colonoscopy
  • inherited cancers
  • surveillance
  • imaging

Data availability statement

Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Data availability statement

Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information.

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Footnotes

  • Twitter @lisrs13, @frankbalaguer

  • Correction notice This article has been corrected since it published Online First. The affiliations for Prof Repici have been updated.

  • Contributors Conception and design: BBSLH, JLAV, YH, MGHvO, LK, PF, ED; data acquisition: all authors; data analysis and interpretation: all authors; writing of the manuscript: BBSLH, YH, ED; critical revision of the manuscript: all authors; statistical analyses: BBSLH, MGHvO; supervision: all authors.

  • Funding FUJIFILM Europe GmbH.

  • Competing interests AR has received loan equipment and a consultancy fee from Medtronic and Fujifilm. BAJB received speaking fees from Olympus, Tillotts Pharma AG and Ovesco Endoscopy. ED received equipment on loan from Olympus and Fujifilm, ED received a research grant from FujiFilm, a consulting fee for medical advice from Tillots, Olympus, Fujifilm, GI Supply and CPP-FAP and a speakers’ fee from Olympus, Roche and GI Supply. FB has endoscopic equipment on loan of Fujifilm, received an honorarium for consultancy from Sysmex, CPP-FAP speaking fees from Norgine, and an editorial fee from Elsevier. MFK has received speaking, teaching and consultancy fees from Olympus (2017 to present) and speaking and teaching fees, and a loan of equipment from Fujifilm (2019) and speaking fees from Medtronic (2019), Alfa Sigma (2017–2019) and Norgine (2018–2019). MP received a research grant from Fujifilm Spain and Casen Recordati, a loan of equipment from Fujifilm, received consultancy fee from Norgine, speaking fee from Norgine, Olympus, Casen Recordati, Janssen and an editorial fee from Thieme. RB has provided consultancy to and received research grants and speakings fees from Pentax (2008 to present) and Fujifilm (2015 to present); his department has received research grants and equipment from Pentax and Fujifilm (2015 to present). PB has received grant funding from Norgine, Fujifilm, Olympus, Pentax, Boston scientific. PF received research support from Boston Scientific research and a consulting fee from Olympus, Cook and Ethicon Endosurgery.

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

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