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  • Standardised training for endoscopic mucosal resection of large non-pedunculated colorectal polyps to reduce recurrence (*STAR-LNPCP study): a multicentre cluster randomised trial

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Endoscopy
Original research
Standardised training for endoscopic mucosal resection of large non-pedunculated colorectal polyps to reduce recurrence (*STAR-LNPCP study): a multicentre cluster randomised trial
  1. Lonne W T Meulen1,2,
  2. Roel M M Bogie1,2,
  3. Peter D Siersema3,
  4. Bjorn Winkens4,5,
  5. Marije S Vlug6,
  6. Frank H J Wolfhagen7,
  7. Martine Baven-Pronk8,
  8. Michael van der Voorn9,
  9. Matthijs P Schwartz10,
  10. Lauran Vogelaar11,
  11. Wouter H de Vos tot Nederveen Cappel12,
  12. Tom C J Seerden13,
  13. Wouter L Hazen14,
  14. Ruud W M Schrauwen15,
  15. Lorenza Alvarez Herrero16,
  16. Ramon-Michel M Schreuder17,
  17. Annick B van Nunen18,
  18. Esther Stoop19,
  19. Gijs J de Bruin20,
  20. Philip Bos21,
  21. Willem A Marsman22,
  22. Edith Kuiper23,
  23. Marc de Bièvre24,
  24. Yasser A Alderlieste25,
  25. Robert Roomer26,
  26. John Groen27,
  27. Marloes Bargeman28,
  28. Monique E van Leerdam29,30,
  29. Linda Roberts-Bos31,
  30. Femke Boersma32,
  31. Karsten Thurnau33,
  32. Roland S de Vries34,
  33. Jos M Ramaker35,
  34. Frank P Vleggaar36,
  35. Rogier J de Ridder1,
  36. María Pellisé37,
  37. Michael J Bourke38,
  38. Ad A M Masclee1,
  39. Leon M G Moons36
  1. 1 Department of Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht, The Netherlands
  2. 2 GROW School for Oncology and Reproduction, Maastricht University, Maastricht, The Netherlands
  3. 3 Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The Netherlands
  4. 4 Department of Methodology and Statistics, Maastricht University, Maastricht, The Netherlands
  5. 5 CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands
  6. 6 Department of Gastroenterology and Hepatology, Dijklander Hospital, Hoorn, The Netherlands
  7. 7 Department of Gastroenterology and Hepatology, Albert Schweitzer Hospital, Dordrecht, The Netherlands
  8. 8 Department of Gastroenterology and Hepatology, Groene Hart Hospital, Gouda, The Netherlands
  9. 9 Department of Gastroenterology and Hepatology, Haga Hospital, Den Haag, The Netherlands
  10. 10 Department of Gastroenterology and Hepatology, Meander Medical Centre, Amersfoort, The Netherlands
  11. 11 Department of Gastroenterology and Hepatology, Diakonessenhuis, Utrecht, The Netherlands
  12. 12 Department of Gastroenterology and Hepatology, Isala Clinics, Zwolle, The Netherlands
  13. 13 Department of Gastroenterology and Hepatology, Amphia Hospital, Breda, The Netherlands
  14. 14 Department of Gastroenterology and Hepatology, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands
  15. 15 Department of Gastroenterology and Hepatology, Bernhoven, Uden, The Netherlands
  16. 16 Department of Gastroenterology and Hepatology, Sint Antonius Hospital, Nieuwegein, The Netherlands
  17. 17 Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, The Netherlands
  18. 18 Department of Gastroenterology and Hepatology, Zuyderland Medical Centre, Sittard-Geleen, The Netherlands
  19. 19 Department of Gastroenterology and Hepatology, Haaglanden Medical Centre, Den Haag, The Netherlands
  20. 20 Department of Gastroenterology and Hepatology, Tergooi Hospital, Hilversum, The Netherlands
  21. 21 Department of Gastroenterology and Hepatology, Hospital Gelderse Vallei, Ede, The Netherlands
  22. 22 Department of Gastroenterology and Hepatology, Spaarne Gasthuis, Haarlem, The Netherlands
  23. 23 Department of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, The Netherlands
  24. 24 Department of Gastroenterology and Hepatology, VieCuri Medical Centre, Venlo, The Netherlands
  25. 25 Department of Gastroenterology and Hepatology, Rivas Zorggroep, Gorinchem, The Netherlands
  26. 26 Department of Gastroenterology and Hepatology, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands
  27. 27 Department of Gastroenterology and Hepatology, Sint Jansdal Hospital, Harderwijk, The Netherlands
  28. 28 Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede, The Netherlands
  29. 29 Department of Gastrointestinal Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands
  30. 30 Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, The Netherlands
  31. 31 Department of Gastroenterology and Hepatology, Laurentius Hospital, Roermond, The Netherlands
  32. 32 Department of Gastroenterology and Hepatology, Gelre Hospitals, Apeldoorn, The Netherlands
  33. 33 Department of Gastroenterology and Hepatology, Hospital group Twente, Almelo, The Netherlands
  34. 34 Department of Gastroenterology and Hepatology, Deventer Hospital, Deventer, The Netherlands
  35. 35 Department of Gastroenterology and Hepatology, Elkerliek Hospital, Helmond, The Netherlands
  36. 36 Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, The Netherlands
  37. 37 Department of Gastroenterology, Hospital Clinic de Barcelona, Barcelona, Spain
  38. 38 Department of Gastroenterology and Hepatology, Westmead Hospital, Westmead, New South Wales, Australia
  1. Correspondence to Dr Leon M G Moons, Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, 3508 GA, Netherlands; L.M.G.Moons{at}umcutrecht.nl

Abstract

Objective Endoscopic mucosal resection (EMR) is the preferred treatment for non-invasive large (≥20 mm) non-pedunculated colorectal polyps (LNPCPs) but is associated with an early recurrence rate of up to 30%. We evaluated whether standardised EMR training could reduce recurrence rates in Dutch community hospitals.

Design In this multicentre cluster randomised trial, 59 endoscopists from 30 hospitals were randomly assigned to the intervention group (e-learning and 2-day training including hands-on session) or control group. From April 2019 to August 2021, all consecutive EMR-treated LNPCPs were included. Primary endpoint was recurrence rate after 6 months.

Results A total of 1412 LNPCPs were included; 699 in the intervention group and 713 in the control group (median size 30 mm vs 30 mm, 45% vs 52% size, morphology, site and access (SMSA) score IV, 64% vs 64% proximal location). Recurrence rates were lower in the intervention group compared with controls (13% vs 25%, OR 0.43; 95% CI 0.23 to 0.78; p=0.005) with similar complication rates (8% vs 9%, OR 0.93; 95% CI 0.64 to 1.36; p=0.720). Recurrences were more often unifocal in the intervention group (92% vs 76%; p=0.006). In sensitivity analysis, the benefit of the intervention on recurrence rate was only observed in the 20–40 mm LNPCPs (5% vs 20% in 20–29 mm, p=0.001; 10% vs 21% in 30–39 mm, p=0.013) but less evident in ≥40 mm LNPCPs (24% vs 31%; p=0.151). In a post hoc analysis, the training effect was maintained in the study group, while in the control group the recurrence rate remained high.

Conclusion A compact standardised EMR training for LNPCPs significantly reduced recurrences in community hospitals. This strongly argues for a national dedicated training programme for endoscopists performing EMR of ≥20 mm LNPCPs. Interestingly, in sensitivity analysis, this benefit was limited for LNPCPs ≥40 mm.

Trial registration number NTR7477.

  • ENDOSCOPIC POLYPECTOMY
  • COLORECTAL ADENOMAS
  • THERAPEUTIC ENDOSCOPY
  • COLORECTAL NEOPLASIA
  • ENDOSCOPIC PROCEDURES

Data availability statement

Data are available upon reasonable request. Deidentifiied participant data are available from the corresponding author.

https://doi.org/10.1136/gutjnl-2023-330020

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    Data availability statement

    Data are available upon reasonable request. Deidentifiied participant data are available from the corresponding author.

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    Footnotes

    • Contributors Study concept and design: LWTM, LMGM, AAMM, MB, MP, PDS. Acquisition of data: all authors. Analysis and interpretation of data: LWTM, BW, LMGM. Drafting of the manuscript: LWTM, LMGM. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: LWTM, BW. Study supervision: LWTM, AAMM, LMGM. Guarantor: LMGM.

    • Funding Dutch Cancer Society (KWF Kankerbestrijding) (2017-10089).

    • Competing interests PDS received grants or speaker fees from Pentax Japan, The eNose Company Netherlands, Microtech China, Lucid Diagnostics USA, Magentiq Eye Israel, Norgine UK/Netherlands and Motus GI USA. FV acts as a consultant for Boston Scientific. MP has received speaker fees from Norgine Iberia (2018–2023), Casen Recordati (2016–2019), Olympus (2018, 2022), Jansen (2018), Medtronic (2022) and Fujifilm (2022); a consultancy fee from GI Supply (2019) and Fujifilm Europe (2022); and research funding from Fujifilm (2019–2021), Casen Recordati (2020), Ziuz (2021) and 3-DMatrix (2021). Her department has received loan material from Fujifilm (2017–ongoing) and a consultancy service with Olympus (2022–ongoing). She is a board member of ESGE and AEG and has received a fee from Thieme as an Endoscopy coeditor (2015–2021). She has shared actions of MiWendo. MJB received research support for ethics-approved studies from Boston Scientific, Cook Medical and Olympus Medical. AAMM received research grants from the Dutch Cancer Society (KWF) and the Dutch Organization for Health Research and Innovation (ZonMW). LMGM acts as a consultant for Boston Scientific.

    • 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.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.