Saperas, E. (Esteban)

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    White-Light Endoscopy Is Adequate for Lynch Syndrome Surveillance in a Randomized and Noninferiority Study
    (Elsevier, 2020) Rivero-Sánchez, L. (Liseth); Arnau-Collell, C. (Coral); Herrero, J. (Jesús); Remedios, D. (David); Cubiella, J. (Joaquin); García-Cougil, M. (Marta); Alvarez, V. (Victoria); Albéniz, E. (Eduardo); Calvo, P. (Patricia); Gordillo, J. (Jordi); Puig, I. (Ignasi); López-Vicente, J. (Jorge); Huerta, A. (Alain); Lopez-Ceron, M. (Maria); Salces, I. (Inmaculada); Peñas, B. (Beatriz); Parejo, S. (Sofía); Rodriguez-de-Santiago, E. (Enrique); Herraiz, M. T. (María Teresa); Carretero, C. (Cristina); Gimeno-García, A.Z. (A. Z.); Saperas, E. (Esteban); Alvarez-Urturi, C. (Cristina); Moreira, R. (Rebeca); Rodriguez-de-Miguel, C. (Cristina); Ocaña, T. (Teresa); Moreira, L. (Leticia); Carballal, S. (Sabela); Sánchez, A. (Ariadna); Jung, G. (Gerhard)
    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.
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    The “diagnose and leave in” strategy for diminutive rectosigmoid polyps in Lynch syndrome: a post hoc analysis from a randomized controlled trial
    (2020) Rivero-Sánchez, L. (Liseth); Gavric, A. (Aleksandar); Herrero, J. (Jesús); Remedios, D. (David); Alvarez, V. (Victoria); Albéniz, E. (Eduardo); Gordillo, J. (Jordi); Puig, I. (Ignasi); López-Vicente, J. (Jorge); Huerta, A. (Alain); Lopez-Ceron, M. (Maria); Salces, I. (Inmaculada); Peñas, B. (Beatriz); Parejo, S. (Sofía); Rodriguez-de-Santiago, E. (Enrique); Herraiz, M. T. (María Teresa); Carretero, C. (Cristina); Gimeno-García, A.Z. (A. Z.); Saperas, E. (Esteban); Alvarez-Urturi, C. (Cristina); Arnau-Collell, C. (Coral); Ortiz, O. (Oswaldo); Sánchez, A. (Ariadna); Jung, G. (Gerhard); Balaguer, F. (Francesc); Pellise, M. (María)
    Background: The "diagnose-and-leave-in" policy has been established to reduce the risks and costs related to unnecessary polypectomies in the average-risk population. In individuals with Lynch syndrome, owing to accelerated carcinogenesis, the general recommendation is to remove all polyps, irrespective of size, location, and appearance. We evaluated the feasibility and safety of the diagnose-and-leave-in strategy in individuals with Lynch syndrome. METHODS : We performed a post hoc analysis based on per-polyp data from a randomized, clinical trial conducted by 24 dedicated colonoscopists at 14 academic centers, in which 256 patients with confirmed Lynch syndrome underwent surveillance colonoscopy from July 2016 to January 2018. In vivo optical diagnosis with confidence level for all detected lesions was obtained before polypectomy using virtual chromoendoscopy alone or with dye-based chromoendoscopy. Primary outcome was the negative predictive value (NPV) for neoplasia of high-confidence optical diagnosis among diminutive (≤ 5 mm) rectosigmoid lesions. Histology was the reference standard. Results: Of 147 rectosigmoid lesions, 128 were diminutive. In 103 of the 128 lesions (81 %), the optical diagnostic confidence was high and showed an NPV of 96.0 % (95 % confidence interval [CI] 88.9 %-98.6 %) and accuracy of 89.3 % (95 %CI 81.9 %-93.9 %). By following the diagnose-and-leave-in policy, we would have avoided 59 % (75/128) of polypectomies at the expense of two diminutive low grade dysplastic adenomas and one diminutive sessile serrated lesion that would have been left in situ. Conclusion: In patients with Lynch syndrome, the diagnose-and-leave-in strategy for diminutive rectosigmoid polyps would be feasible and safe.