Diagnostic yield and miss rate of EndoRings in an organized colorectal cancer screening program

the SMART (Study Methodology for ADR-Related Technology) trial

Cesare Hassan, Carlo Senore, Gianpiero Manes, Lorenzo Fuccio, Federico Iacopini, Luigi Ricciardiello, Andrea Anderloni, Leonardo Frazzoni, Riccardo Ballanti, Germana de Nucci, Dora Colussi, Davide Redaelli, Roberto Lorenzetti, Massimo Devani, Ilaria Arena, Cristina Grossi, Fabio Andrei, Eleonora Balestrazzi, Prateek Sharma, Douglas Rex & 1 others Alessandro Repici

Research output: Contribution to journalArticle

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Abstract

Background and Aims: The EndoRings add-on has been claimed to improve adenoma detection at colonoscopy, but available data are inconsistent. When testing a new technology, parallel and crossover methodologies measure different outcomes, leaving uncertainty about their correspondence. The aims of this study were to compare the diagnostic yield and miss rate of the EndoRings for colorectal neoplasia. Methods: Consecutive patients undergoing colonoscopy after a positive fecal immunochemical test (FIT) within an organized screening program in 7 Italian centers were randomized between a parallel (EndoRings or standard) or a crossover (EndoRings/standard or standard/EndoRings) methodology. Outcomes measures were the adenoma detection rate (ADR) and advanced adenoma detection rate (AADR) in the parallel arms and the miss rate of adenomas in the crossover arms. Results: Of 958 eligible patients, 927 (317 EndoRings; 317 standard; 142 EndoRings/standard; 151 standard/Endo-Rings) were included in the final analysis. In the parallel arms (mean ADR, 51.3%; mean AADR, 25.4%), no difference between standard and EndoRings was found for both ADR (relative risk [RR], 1.10; 95% confidence interval [CI], 0.95-1.28) and AADR (RR, 1.16; 95% CI, 0.88-1.51), as well as for the mean number of adenomas and advanced adenomas per patient (EndoRings, 1.9 ± 1.3 and 1.0 ± 1.2; standard, 2.1 ± 1.5 and 1.0 ± 1.2; P = not significant for both comparisons). In the crossover arms, no difference in the miss rate for adenomas between EndoRings and standard was found at per polyp (RR, 1.43; 95% CI, 0.97-2.10) or per-patient analysis (24% vs 26%; P =.76). Conclusions: No statistically significant difference in diagnostic yield and miss rate between EndoRings and standard colonoscopy was detected in patients with a positive FIT result. A clinically relevant correspondence between miss and detection rates was shown, supporting a cause-effect relationship. (ISRCTN registry: ISRCTN10357435.)

Original languageEnglish (US)
JournalGastrointestinal Endoscopy
DOIs
StateAccepted/In press - Jan 1 2019

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Early Detection of Cancer
Adenoma
Colorectal Neoplasms
Technology
Colonoscopy
Confidence Intervals
Outcome Assessment (Health Care)
Polyps
Uncertainty
Registries

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

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Diagnostic yield and miss rate of EndoRings in an organized colorectal cancer screening program : the SMART (Study Methodology for ADR-Related Technology) trial. / Hassan, Cesare; Senore, Carlo; Manes, Gianpiero; Fuccio, Lorenzo; Iacopini, Federico; Ricciardiello, Luigi; Anderloni, Andrea; Frazzoni, Leonardo; Ballanti, Riccardo; de Nucci, Germana; Colussi, Dora; Redaelli, Davide; Lorenzetti, Roberto; Devani, Massimo; Arena, Ilaria; Grossi, Cristina; Andrei, Fabio; Balestrazzi, Eleonora; Sharma, Prateek; Rex, Douglas; Repici, Alessandro.

In: Gastrointestinal Endoscopy, 01.01.2019.

Research output: Contribution to journalArticle

Hassan, C, Senore, C, Manes, G, Fuccio, L, Iacopini, F, Ricciardiello, L, Anderloni, A, Frazzoni, L, Ballanti, R, de Nucci, G, Colussi, D, Redaelli, D, Lorenzetti, R, Devani, M, Arena, I, Grossi, C, Andrei, F, Balestrazzi, E, Sharma, P, Rex, D & Repici, A 2019, 'Diagnostic yield and miss rate of EndoRings in an organized colorectal cancer screening program: the SMART (Study Methodology for ADR-Related Technology) trial', Gastrointestinal Endoscopy. https://doi.org/10.1016/j.gie.2018.10.019
Hassan, Cesare ; Senore, Carlo ; Manes, Gianpiero ; Fuccio, Lorenzo ; Iacopini, Federico ; Ricciardiello, Luigi ; Anderloni, Andrea ; Frazzoni, Leonardo ; Ballanti, Riccardo ; de Nucci, Germana ; Colussi, Dora ; Redaelli, Davide ; Lorenzetti, Roberto ; Devani, Massimo ; Arena, Ilaria ; Grossi, Cristina ; Andrei, Fabio ; Balestrazzi, Eleonora ; Sharma, Prateek ; Rex, Douglas ; Repici, Alessandro. / Diagnostic yield and miss rate of EndoRings in an organized colorectal cancer screening program : the SMART (Study Methodology for ADR-Related Technology) trial. In: Gastrointestinal Endoscopy. 2019.
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abstract = "Background and Aims: The EndoRings add-on has been claimed to improve adenoma detection at colonoscopy, but available data are inconsistent. When testing a new technology, parallel and crossover methodologies measure different outcomes, leaving uncertainty about their correspondence. The aims of this study were to compare the diagnostic yield and miss rate of the EndoRings for colorectal neoplasia. Methods: Consecutive patients undergoing colonoscopy after a positive fecal immunochemical test (FIT) within an organized screening program in 7 Italian centers were randomized between a parallel (EndoRings or standard) or a crossover (EndoRings/standard or standard/EndoRings) methodology. Outcomes measures were the adenoma detection rate (ADR) and advanced adenoma detection rate (AADR) in the parallel arms and the miss rate of adenomas in the crossover arms. Results: Of 958 eligible patients, 927 (317 EndoRings; 317 standard; 142 EndoRings/standard; 151 standard/Endo-Rings) were included in the final analysis. In the parallel arms (mean ADR, 51.3{\%}; mean AADR, 25.4{\%}), no difference between standard and EndoRings was found for both ADR (relative risk [RR], 1.10; 95{\%} confidence interval [CI], 0.95-1.28) and AADR (RR, 1.16; 95{\%} CI, 0.88-1.51), as well as for the mean number of adenomas and advanced adenomas per patient (EndoRings, 1.9 ± 1.3 and 1.0 ± 1.2; standard, 2.1 ± 1.5 and 1.0 ± 1.2; P = not significant for both comparisons). In the crossover arms, no difference in the miss rate for adenomas between EndoRings and standard was found at per polyp (RR, 1.43; 95{\%} CI, 0.97-2.10) or per-patient analysis (24{\%} vs 26{\%}; P =.76). Conclusions: No statistically significant difference in diagnostic yield and miss rate between EndoRings and standard colonoscopy was detected in patients with a positive FIT result. A clinically relevant correspondence between miss and detection rates was shown, supporting a cause-effect relationship. (ISRCTN registry: ISRCTN10357435.)",
author = "Cesare Hassan and Carlo Senore and Gianpiero Manes and Lorenzo Fuccio and Federico Iacopini and Luigi Ricciardiello and Andrea Anderloni and Leonardo Frazzoni and Riccardo Ballanti and {de Nucci}, Germana and Dora Colussi and Davide Redaelli and Roberto Lorenzetti and Massimo Devani and Ilaria Arena and Cristina Grossi and Fabio Andrei and Eleonora Balestrazzi and Prateek Sharma and Douglas Rex and Alessandro Repici",
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TY - JOUR

T1 - Diagnostic yield and miss rate of EndoRings in an organized colorectal cancer screening program

T2 - the SMART (Study Methodology for ADR-Related Technology) trial

AU - Hassan, Cesare

AU - Senore, Carlo

AU - Manes, Gianpiero

AU - Fuccio, Lorenzo

AU - Iacopini, Federico

AU - Ricciardiello, Luigi

AU - Anderloni, Andrea

AU - Frazzoni, Leonardo

AU - Ballanti, Riccardo

AU - de Nucci, Germana

AU - Colussi, Dora

AU - Redaelli, Davide

AU - Lorenzetti, Roberto

AU - Devani, Massimo

AU - Arena, Ilaria

AU - Grossi, Cristina

AU - Andrei, Fabio

AU - Balestrazzi, Eleonora

AU - Sharma, Prateek

AU - Rex, Douglas

AU - Repici, Alessandro

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background and Aims: The EndoRings add-on has been claimed to improve adenoma detection at colonoscopy, but available data are inconsistent. When testing a new technology, parallel and crossover methodologies measure different outcomes, leaving uncertainty about their correspondence. The aims of this study were to compare the diagnostic yield and miss rate of the EndoRings for colorectal neoplasia. Methods: Consecutive patients undergoing colonoscopy after a positive fecal immunochemical test (FIT) within an organized screening program in 7 Italian centers were randomized between a parallel (EndoRings or standard) or a crossover (EndoRings/standard or standard/EndoRings) methodology. Outcomes measures were the adenoma detection rate (ADR) and advanced adenoma detection rate (AADR) in the parallel arms and the miss rate of adenomas in the crossover arms. Results: Of 958 eligible patients, 927 (317 EndoRings; 317 standard; 142 EndoRings/standard; 151 standard/Endo-Rings) were included in the final analysis. In the parallel arms (mean ADR, 51.3%; mean AADR, 25.4%), no difference between standard and EndoRings was found for both ADR (relative risk [RR], 1.10; 95% confidence interval [CI], 0.95-1.28) and AADR (RR, 1.16; 95% CI, 0.88-1.51), as well as for the mean number of adenomas and advanced adenomas per patient (EndoRings, 1.9 ± 1.3 and 1.0 ± 1.2; standard, 2.1 ± 1.5 and 1.0 ± 1.2; P = not significant for both comparisons). In the crossover arms, no difference in the miss rate for adenomas between EndoRings and standard was found at per polyp (RR, 1.43; 95% CI, 0.97-2.10) or per-patient analysis (24% vs 26%; P =.76). Conclusions: No statistically significant difference in diagnostic yield and miss rate between EndoRings and standard colonoscopy was detected in patients with a positive FIT result. A clinically relevant correspondence between miss and detection rates was shown, supporting a cause-effect relationship. (ISRCTN registry: ISRCTN10357435.)

AB - Background and Aims: The EndoRings add-on has been claimed to improve adenoma detection at colonoscopy, but available data are inconsistent. When testing a new technology, parallel and crossover methodologies measure different outcomes, leaving uncertainty about their correspondence. The aims of this study were to compare the diagnostic yield and miss rate of the EndoRings for colorectal neoplasia. Methods: Consecutive patients undergoing colonoscopy after a positive fecal immunochemical test (FIT) within an organized screening program in 7 Italian centers were randomized between a parallel (EndoRings or standard) or a crossover (EndoRings/standard or standard/EndoRings) methodology. Outcomes measures were the adenoma detection rate (ADR) and advanced adenoma detection rate (AADR) in the parallel arms and the miss rate of adenomas in the crossover arms. Results: Of 958 eligible patients, 927 (317 EndoRings; 317 standard; 142 EndoRings/standard; 151 standard/Endo-Rings) were included in the final analysis. In the parallel arms (mean ADR, 51.3%; mean AADR, 25.4%), no difference between standard and EndoRings was found for both ADR (relative risk [RR], 1.10; 95% confidence interval [CI], 0.95-1.28) and AADR (RR, 1.16; 95% CI, 0.88-1.51), as well as for the mean number of adenomas and advanced adenomas per patient (EndoRings, 1.9 ± 1.3 and 1.0 ± 1.2; standard, 2.1 ± 1.5 and 1.0 ± 1.2; P = not significant for both comparisons). In the crossover arms, no difference in the miss rate for adenomas between EndoRings and standard was found at per polyp (RR, 1.43; 95% CI, 0.97-2.10) or per-patient analysis (24% vs 26%; P =.76). Conclusions: No statistically significant difference in diagnostic yield and miss rate between EndoRings and standard colonoscopy was detected in patients with a positive FIT result. A clinically relevant correspondence between miss and detection rates was shown, supporting a cause-effect relationship. (ISRCTN registry: ISRCTN10357435.)

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DO - 10.1016/j.gie.2018.10.019

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