Liseth Rivero-Sánchez1, Coral Arnau-Collell2, Jesús Herrero3, David Remedios3, Joaquín Cubiella3, Marta García-Cougil3, Victoria Alvarez4, Eduardo Albéniz5, Patricia Calvo6, Jordi Gordillo7, Ignasi Puig8, Jorge López-Vicente9, Alain Huerta10, María López-Cerón11, Inmaculada Salces11, Beatriz Peñas12, Sofía Parejo13, Enrique Rodriguez de Santiago13, Maite Herraiz14, Cristina Carretero14, Antonio Z Gimeno-Garcia15, Esteban Saperas16, Cristina Alvarez-Urturi17, Rebeca Moreira18, Cristina Rodriguez de Miguel2, Teresa Ocaña18, Leticia Moreira1, Sabela Carballal1, Ariadna Sánchez1, Gerhard Jung1, Antoni Castells1, Josep Llach18, Francesc Balaguer1, María Pellisé19. 1. Hospital Clinic of Barcelona, Department of Gastroenterology, Barcelona, Spain; Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain. 2. Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain. 3. Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, Instituto de Investigación Biomédica Galicia Sur, CIBERehd, Ourense, Spain. 4. Complejo Hospitalario de Pontevedra, Department of Gastroenterology, Pontevedra, Spain. 5. Complejo Hospitalario de Navarra, Digestive System Service, Endoscopy Unit, Navarrabiomed, Universidad Pública de Navarra, IdiSNa, Pamplona, Spain. 6. Complejo Hospitalario de Navarra, Nurse High-Risk Clinic, Pamplona, Spain. 7. Hospital de la Santa Creu i Sant Pau, Gastroenterology Unit, Barcelona, Spain. 8. Althaia, Xarxa Assistencial Universitària de Manresa, Digestive System Service, Manresa, Spain. 9. Hospital Universitario de Móstoles, Digestive System Service, Móstoles, Spain. 10. Hospital Galdakao-Usansolo, Department of Gastroenterology, Galdakao, Spain. 11. Hospital Universitario 12 de Octubre, Digestive System Service, Madrid, Spain. 12. Hospital Universitario Ramón y Cajal, Department of Gastroenterology, Madrid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain. 13. Hospital Universitario Ramón y Cajal, Department of Gastroenterology, Madrid, Spain. 14. University of Navarra Clinic-IdiSNA, Gastroenterology Department, Pamplona, Spain. 15. Hospital Universitario de Canarias, Digestive System Service, Santa Cruz de Tenerife, Spain. 16. Hospital General de Catalunya, Digestive System Service, Sant Cugat del Vallès, Spain. 17. Hospital del Mar, Gastroenterology Unit, Barcelona, Spain. 18. Hospital Clinic of Barcelona, Department of Gastroenterology, Barcelona, Spain. 19. Hospital Clinic of Barcelona, Department of Gastroenterology, Barcelona, Spain; Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain. Electronic address: mpellise@clinic.cat.
Abstract
BACKGROUND & AIMS: Dye-based pancolonic chromoendoscopy is recommended for colorectal cancer surveillance in patients with Lynch syndrome. However, there is scarce evidence to support its superiority to high-definition white-light endoscopy. We performed a prospective study assess whether in the hands of high detecting colonoscopists, high-definition, white-light endoscopy is noninferior to pancolonic chromoendoscopy for detection of adenomas in patients with Lynch syndrome. METHODS: We conducted a parallel controlled study, from July 2016 through January 2018 at 14 centers in Spain of adults with pathogenic germline variants in mismatch repair genes (60% women; mean age, 47 ± 14 years) under surveillance. Patients were randomly assigned to groups that underwent high-definition white-light endoscopy (n = 128) or pancolonic chromoendoscopy (n = 128) evaluations by 24 colonoscopists who specialized in detection of colorectal lesions in high-risk patients for colorectal cancer. Adenoma detection rates (defined as the proportion of patients with at least 1 adenoma) were compared between groups, with a noninferiority margin (relative difference) of 15%. RESULTS: We found an important overlap of confidence intervals (CIs) and no significant difference in adenoma detection rates by pancolonic chromoendoscopy (34.4%; 95% CI 26.4%-43.3%) vs white-light endoscopy (28.1%; 95% CI 21.1%-36.4%; P = .28). However, pancolonic chromoendoscopy detected serrated lesions in a significantly higher proportion of patients (37.5%; 95% CI 29.5-46.1) than white-light endoscopy (23.4%; 95% CI 16.9-31.4; P = .01). However, there were no significant differences between groups in proportions of patients found to have serrated lesions of 5 mm or larger (9.4% vs 7.0%; P = .49), of proximal location (11.7% vs 10.2%; P = .68), or sessile serrated lesions (3.9% vs 5.5%; P = .55), respectively. Total procedure and withdrawal times with pancolonic chromoendoscopy (30.7 ± 12.8 minutes and 18.3 ± 7.6 minutes, respectively) were significantly longer than with white-light endoscopy (22.4 ± 8.7 minutes and 13.5 ± 5.6 minutes; P < .001). CONCLUSIONS: In a randomized parallel trial, we found that for Lynch syndrome surveillance, high-definition white-light endoscopy is not inferior to pancolonic chromoendoscopy if performed by experienced and dedicated endoscopists. ClinicalTrials.gov no: NCT02951390.
RCT Entities:
BACKGROUND & AIMS: Dye-based pancolonic chromoendoscopy is recommended for colorectal cancer surveillance in patients with Lynch syndrome. However, there is scarce evidence to support its superiority to high-definition white-light endoscopy. We performed a prospective study assess whether in the hands of high detecting colonoscopists, high-definition, white-light endoscopy is noninferior to pancolonic chromoendoscopy for detection of adenomas in patients with Lynch syndrome. METHODS: We conducted a parallel controlled study, from July 2016 through January 2018 at 14 centers in Spain of adults with pathogenic germline variants in mismatch repair genes (60% women; mean age, 47 ± 14 years) under surveillance. Patients were randomly assigned to groups that underwent high-definition white-light endoscopy (n = 128) or pancolonic chromoendoscopy (n = 128) evaluations by 24 colonoscopists who specialized in detection of colorectal lesions in high-risk patients for colorectal cancer. Adenoma detection rates (defined as the proportion of patients with at least 1 adenoma) were compared between groups, with a noninferiority margin (relative difference) of 15%. RESULTS: We found an important overlap of confidence intervals (CIs) and no significant difference in adenoma detection rates by pancolonic chromoendoscopy (34.4%; 95% CI 26.4%-43.3%) vs white-light endoscopy (28.1%; 95% CI 21.1%-36.4%; P = .28). However, pancolonic chromoendoscopy detected serrated lesions in a significantly higher proportion of patients (37.5%; 95% CI 29.5-46.1) than white-light endoscopy (23.4%; 95% CI 16.9-31.4; P = .01). However, there were no significant differences between groups in proportions of patients found to have serrated lesions of 5 mm or larger (9.4% vs 7.0%; P = .49), of proximal location (11.7% vs 10.2%; P = .68), or sessile serrated lesions (3.9% vs 5.5%; P = .55), respectively. Total procedure and withdrawal times with pancolonic chromoendoscopy (30.7 ± 12.8 minutes and 18.3 ± 7.6 minutes, respectively) were significantly longer than with white-light endoscopy (22.4 ± 8.7 minutes and 13.5 ± 5.6 minutes; P < .001). CONCLUSIONS: In a randomized parallel trial, we found that for Lynch syndrome surveillance, high-definition white-light endoscopy is not inferior to pancolonic chromoendoscopy if performed by experienced and dedicated endoscopists. ClinicalTrials.gov no: NCT02951390.
Authors: Britt B S L Houwen; Yark Hazewinkel; María Pellisé; Liseth Rivero-Sánchez; Francesc Balaguer; Raf Bisschops; Sabine Tejpar; Alessandro Repici; D Ramsoekh; Maarten A J M Jacobs; Ramon-Michel M Schreuder; Michal Filip Kaminski; Maria Rupinska; Pradeep Bhandari; Martijn G H van Oijen; Lianne Koens; Barbara A J Bastiaansen; Kristien M Tytgat; Paul Fockens; Jasper L A Vleugels; E Dekker Journal: Gut Date: 2021-03-18 Impact factor: 23.059