1. White-Light Endoscopy Is Adequate for Lynch Syndrome Surveillance in a Randomized and Noninferiority Study
- Author
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María López-Cerón, Antonio Z. Gimeno-García, Ariadna Sánchez, Sofía Parejo, Victoria Alvarez, Liseth Rivero-Sánchez, Beatriz Peñas, David Remedios, Joaquín Cubiella, Cristina Rodríguez de Miguel, Gerhard Jung, Patricia Calvo, Cristina Carretero, Alain Huerta, Maite Herraiz, Teresa Ocaña, Jorge López-Vicente, Leticia Moreira, Jordi Gordillo, Esteban Saperas, Maria Pellise, Antoni Castells, Rebeca Moreira, Cristina Alvarez-Urturi, Jesús Herrero, Sabela Carballal, Eduardo Albéniz, Josep Llach, Francesc Balaguer, Inmaculada Salces, Ignasi Puig, Marta García-Cougil, Coral Arnau-Collell, and Enrique Rodríguez de Santiago
- Subjects
0301 basic medicine ,Adenoma ,Adult ,Male ,medicine.medical_specialty ,ADR ,Colorectal cancer ,Colonoscopy ,Gastroenterology ,Chromoendoscopy ,03 medical and health sciences ,Polyp ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,Panchromoendoscopy ,Prospective Studies ,Prospective cohort study ,Early Detection of Cancer ,Hepatology ,medicine.diagnostic_test ,business.industry ,Middle Aged ,medicine.disease ,Colorectal Neoplasms, Hereditary Nonpolyposis ,Confidence interval ,Lynch syndrome ,CRC ,Endoscopy ,030104 developmental biology ,Population Surveillance ,030211 gastroenterology & hepatology ,Female ,business ,Colorectal Neoplasms - 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 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.
- Published
- 2019