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

Author

MS MDL 1, Cancer, Meulen, Lonne W T, Bogie, Roel M M, Siersema, Peter D, Winkens, Bjorn, Vlug, Marije S, Wolfhagen, Frank H J, Baven-Pronk, Martine, van der Voorn, Michael, Schwartz, Matthijs P, Vogelaar, Lauran, de Vos Tot Nederveen Cappel, Wouter H, Seerden, Tom C J, Hazen, Wouter L, Schrauwen, Ruud W M, Alvarez Herrero, Lorenza, Schreuder, Ramon-Michel M, van Nunen, Annick B, Stoop, Esther, de Bruin, Gijs J, Bos, Philip, Marsman, Willem A, Kuiper, Edith, de Bièvre, Marc, Alderlieste, Yasser A, Roomer, Robert, Groen, John, Bargeman, Marloes, van Leerdam, Monique E, Roberts-Bos, Linda, Boersma, Femke, Thurnau, Karsten, de Vries, Roland S, Ramaker, Jos M, Vleggaar, Frank P, de Ridder, Rogier J, Pellisé, María, Bourke, Michael J, Masclee, Ad A M, Moons, Leon M G, MS MDL 1, Cancer, Meulen, Lonne W T, Bogie, Roel M M, Siersema, Peter D, Winkens, Bjorn, Vlug, Marije S, Wolfhagen, Frank H J, Baven-Pronk, Martine, van der Voorn, Michael, Schwartz, Matthijs P, Vogelaar, Lauran, de Vos Tot Nederveen Cappel, Wouter H, Seerden, Tom C J, Hazen, Wouter L, Schrauwen, Ruud W M, Alvarez Herrero, Lorenza, Schreuder, Ramon-Michel M, van Nunen, Annick B, Stoop, Esther, de Bruin, Gijs J, Bos, Philip, Marsman, Willem A, Kuiper, Edith, de Bièvre, Marc, Alderlieste, Yasser A, Roomer, Robert, Groen, John, Bargeman, Marloes, van Leerdam, Monique E, Roberts-Bos, Linda, Boersma, Femke, Thurnau, Karsten, de Vries, Roland S, Ramaker, Jos M, Vleggaar, Frank P, de Ridder, Rogier J, Pellisé, María, Bourke, Michael J, Masclee, Ad A M, and Moons, Leon M G

Published
2024

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

Author

Meulen, Lonne W T, Bogie, Roel M M, Siersema, Peter D, Winkens, Bjorn, Vlug, Marije S, Wolfhagen, Frank H J, Baven-Pronk, Martine, van der Voorn, Michael, Schwartz, Matthijs P, Vogelaar, Lauran, de Vos Tot Nederveen Cappel, Wouter H, Seerden, Tom C J, Hazen, Wouter L, Schrauwen, Ruud W M, Alvarez Herrero, Lorenza, Schreuder, Ramon-Michel M, van Nunen, Annick B, Stoop, Esther, de Bruin, Gijs J, Bos, Philip, Marsman, Willem A, Kuiper, Edith, de Bièvre, Marc, Alderlieste, Yasser A, Roomer, Robert, Groen, John, Bargeman, Marloes, van Leerdam, Monique E, Roberts-Bos, Linda, Boersma, Femke, Thurnau, Karsten, de Vries, Roland S, Ramaker, Jos M, Vleggaar, Frank P, de Ridder, Rogier J, Pellisé, María, Bourke, Michael J, Masclee, Ad A M, Moons, Leon M G, Meulen, Lonne W T, Bogie, Roel M M, Siersema, Peter D, Winkens, Bjorn, Vlug, Marije S, Wolfhagen, Frank H J, Baven-Pronk, Martine, van der Voorn, Michael, Schwartz, Matthijs P, Vogelaar, Lauran, de Vos Tot Nederveen Cappel, Wouter H, Seerden, Tom C J, Hazen, Wouter L, Schrauwen, Ruud W M, Alvarez Herrero, Lorenza, Schreuder, Ramon-Michel M, van Nunen, Annick B, Stoop, Esther, de Bruin, Gijs J, Bos, Philip, Marsman, Willem A, Kuiper, Edith, de Bièvre, Marc, Alderlieste, Yasser A, Roomer, Robert, Groen, John, Bargeman, Marloes, van Leerdam, Monique E, Roberts-Bos, Linda, Boersma, Femke, Thurnau, Karsten, de Vries, Roland S, Ramaker, Jos M, Vleggaar, Frank P, de Ridder, Rogier J, Pellisé, María, Bourke, Michael J, Masclee, Ad A M, and Moons, Leon M G

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.

Published
2024

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

Author

Meulen LWT, Bogie RMM, Siersema PD, Winkens B, Vlug MS, Wolfhagen FHJ, Baven-Pronk M, van der Voorn M, Schwartz MP, Vogelaar L, de Vos Tot Nederveen Cappel WH, Seerden TCJ, Hazen WL, Schrauwen RWM, Alvarez Herrero L, Schreuder RM, van Nunen AB, Stoop E, de Bruin GJ, Bos P, Marsman WA, Kuiper E, de Bièvre M, Alderlieste YA, Roomer R, Groen J, Bargeman M, van Leerdam ME, Roberts-Bos L, Boersma F, Thurnau K, de Vries RS, Ramaker JM, Vleggaar FP, de Ridder RJ, Pellisé M, Bourke MJ, Masclee AAM, and Moons LMG

Subjects
Humans, Colonoscopy, Colonic Polyps surgery, Colorectal Neoplasms surgery, Endoscopic Mucosal Resection
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., Competing Interests: 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., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2024
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