Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population

Douglas Rex, Samuel N. Adler, James Aisenberg, Wilmot C. Burch, Cristina Carretero, Yehuda Chowers, Steven A. Fein, Steven E. Fern, Ignacio Fernandez-Urien Sainz, Alexander Fich, Eyal Gal, John C. Horlander, Kim L. Isaacs, Revital Kariv, Adi Lahat, Wai Keung Leung, Pramod R. Malik, Doug Morgan, Neofytos Papageorgiou, David P. RomeoSmita S. Shah, Matti Waterman

Research output: Contribution to journalArticle

69 Citations (Scopus)

Abstract

Background & Aims Capsule colonoscopy is a minimally invasive imaging method. We measured the accuracy of this technology in detecting polyps 6 mm or larger in an average-risk screening population. Methods In a prospective study, asymptomatic subjects (n = 884) underwent capsule colonoscopy followed by conventional colonoscopy (the reference) several weeks later, with an endoscopist blinded to capsule results, at 10 centers in the United States and 6 centers in Israel from June 2011 through April 2012. An unblinded colonoscopy was performed on subjects found to have lesions 6 mm or larger by capsule but not conventional colonoscopy. Results Among the 884 subjects enrolled, 695 (79%) were included in the analysis of capsule performance for all polyps. There were 77 exclusions (9%) for inadequate cleansing and whole-colon capsule transit time fewer than 40 minutes, 45 exclusions (5%) before capsule ingestion, 15 exclusions (2%) after ingestion and before colonoscopy, and 15 exclusions (2%) for site termination. Capsule colonoscopy identified subjects with 1 or more polyps 6 mm or larger with 81% sensitivity (95% confidence interval [CI], 77%-84%) and 93% specificity (95% CI, 91%-95%), and polyps 10 mm or larger with 80% sensitivity (95% CI, 74%-86%) and 97% specificity (95% CI, 96%-98%). Capsule colonoscopy identified subjects with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity (95% CI, 82%-93) and 82% specificity (95% CI, 80%-83%), and 10 mm or larger with 92% sensitivity (95% CI, 82%-97%) and 95% specificity (95% CI, 94%-95%). Sessile serrated polyps and hyperplastic polyps accounted for 26% and 37%, respectively, of false-negative findings from capsule analyses. Conclusions In an average-risk screening population, technically adequate capsule colonoscopy identified individuals with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity and 82% specificity. Capsule performance seems adequate for patients who cannot undergo colonoscopy or who had incomplete colonoscopies. Additional studies are needed to improve capsule detection of serrated lesions. Clinicaltrials.gov number: NCT01372878.

Original languageEnglish (US)
Pages (from-to)948-967.e2
JournalGastroenterology
Volume148
Issue number5
DOIs
StatePublished - May 1 2015

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Colonoscopy
Polyps
Capsules
Population
Confidence Intervals
Adenoma
Eating
Israel
Colon
Prospective Studies

Keywords

  • Colon Cancer Detection
  • Colorectal Lesion
  • Diagnosis Tumor
  • Neoplasm

ASJC Scopus subject areas

  • Gastroenterology
  • Medicine(all)

Cite this

Rex, D., Adler, S. N., Aisenberg, J., Burch, W. C., Carretero, C., Chowers, Y., ... Waterman, M. (2015). Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population. Gastroenterology, 148(5), 948-967.e2. https://doi.org/10.1053/j.gastro.2015.01.025

Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population. / Rex, Douglas; Adler, Samuel N.; Aisenberg, James; Burch, Wilmot C.; Carretero, Cristina; Chowers, Yehuda; Fein, Steven A.; Fern, Steven E.; Fernandez-Urien Sainz, Ignacio; Fich, Alexander; Gal, Eyal; Horlander, John C.; Isaacs, Kim L.; Kariv, Revital; Lahat, Adi; Leung, Wai Keung; Malik, Pramod R.; Morgan, Doug; Papageorgiou, Neofytos; Romeo, David P.; Shah, Smita S.; Waterman, Matti.

In: Gastroenterology, Vol. 148, No. 5, 01.05.2015, p. 948-967.e2.

Research output: Contribution to journalArticle

Rex, D, Adler, SN, Aisenberg, J, Burch, WC, Carretero, C, Chowers, Y, Fein, SA, Fern, SE, Fernandez-Urien Sainz, I, Fich, A, Gal, E, Horlander, JC, Isaacs, KL, Kariv, R, Lahat, A, Leung, WK, Malik, PR, Morgan, D, Papageorgiou, N, Romeo, DP, Shah, SS & Waterman, M 2015, 'Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population', Gastroenterology, vol. 148, no. 5, pp. 948-967.e2. https://doi.org/10.1053/j.gastro.2015.01.025
Rex D, Adler SN, Aisenberg J, Burch WC, Carretero C, Chowers Y et al. Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population. Gastroenterology. 2015 May 1;148(5):948-967.e2. https://doi.org/10.1053/j.gastro.2015.01.025
Rex, Douglas ; Adler, Samuel N. ; Aisenberg, James ; Burch, Wilmot C. ; Carretero, Cristina ; Chowers, Yehuda ; Fein, Steven A. ; Fern, Steven E. ; Fernandez-Urien Sainz, Ignacio ; Fich, Alexander ; Gal, Eyal ; Horlander, John C. ; Isaacs, Kim L. ; Kariv, Revital ; Lahat, Adi ; Leung, Wai Keung ; Malik, Pramod R. ; Morgan, Doug ; Papageorgiou, Neofytos ; Romeo, David P. ; Shah, Smita S. ; Waterman, Matti. / Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population. In: Gastroenterology. 2015 ; Vol. 148, No. 5. pp. 948-967.e2.
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abstract = "Background & Aims Capsule colonoscopy is a minimally invasive imaging method. We measured the accuracy of this technology in detecting polyps 6 mm or larger in an average-risk screening population. Methods In a prospective study, asymptomatic subjects (n = 884) underwent capsule colonoscopy followed by conventional colonoscopy (the reference) several weeks later, with an endoscopist blinded to capsule results, at 10 centers in the United States and 6 centers in Israel from June 2011 through April 2012. An unblinded colonoscopy was performed on subjects found to have lesions 6 mm or larger by capsule but not conventional colonoscopy. Results Among the 884 subjects enrolled, 695 (79{\%}) were included in the analysis of capsule performance for all polyps. There were 77 exclusions (9{\%}) for inadequate cleansing and whole-colon capsule transit time fewer than 40 minutes, 45 exclusions (5{\%}) before capsule ingestion, 15 exclusions (2{\%}) after ingestion and before colonoscopy, and 15 exclusions (2{\%}) for site termination. Capsule colonoscopy identified subjects with 1 or more polyps 6 mm or larger with 81{\%} sensitivity (95{\%} confidence interval [CI], 77{\%}-84{\%}) and 93{\%} specificity (95{\%} CI, 91{\%}-95{\%}), and polyps 10 mm or larger with 80{\%} sensitivity (95{\%} CI, 74{\%}-86{\%}) and 97{\%} specificity (95{\%} CI, 96{\%}-98{\%}). Capsule colonoscopy identified subjects with 1 or more conventional adenomas 6 mm or larger with 88{\%} sensitivity (95{\%} CI, 82{\%}-93) and 82{\%} specificity (95{\%} CI, 80{\%}-83{\%}), and 10 mm or larger with 92{\%} sensitivity (95{\%} CI, 82{\%}-97{\%}) and 95{\%} specificity (95{\%} CI, 94{\%}-95{\%}). Sessile serrated polyps and hyperplastic polyps accounted for 26{\%} and 37{\%}, respectively, of false-negative findings from capsule analyses. Conclusions In an average-risk screening population, technically adequate capsule colonoscopy identified individuals with 1 or more conventional adenomas 6 mm or larger with 88{\%} sensitivity and 82{\%} specificity. Capsule performance seems adequate for patients who cannot undergo colonoscopy or who had incomplete colonoscopies. Additional studies are needed to improve capsule detection of serrated lesions. Clinicaltrials.gov number: NCT01372878.",
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author = "Douglas Rex and Adler, {Samuel N.} and James Aisenberg and Burch, {Wilmot C.} and Cristina Carretero and Yehuda Chowers and Fein, {Steven A.} and Fern, {Steven E.} and {Fernandez-Urien Sainz}, Ignacio and Alexander Fich and Eyal Gal and Horlander, {John C.} and Isaacs, {Kim L.} and Revital Kariv and Adi Lahat and Leung, {Wai Keung} and Malik, {Pramod R.} and Doug Morgan and Neofytos Papageorgiou and Romeo, {David P.} and Shah, {Smita S.} and Matti Waterman",
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TY - JOUR

T1 - Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population

AU - Rex, Douglas

AU - Adler, Samuel N.

AU - Aisenberg, James

AU - Burch, Wilmot C.

AU - Carretero, Cristina

AU - Chowers, Yehuda

AU - Fein, Steven A.

AU - Fern, Steven E.

AU - Fernandez-Urien Sainz, Ignacio

AU - Fich, Alexander

AU - Gal, Eyal

AU - Horlander, John C.

AU - Isaacs, Kim L.

AU - Kariv, Revital

AU - Lahat, Adi

AU - Leung, Wai Keung

AU - Malik, Pramod R.

AU - Morgan, Doug

AU - Papageorgiou, Neofytos

AU - Romeo, David P.

AU - Shah, Smita S.

AU - Waterman, Matti

PY - 2015/5/1

Y1 - 2015/5/1

N2 - Background & Aims Capsule colonoscopy is a minimally invasive imaging method. We measured the accuracy of this technology in detecting polyps 6 mm or larger in an average-risk screening population. Methods In a prospective study, asymptomatic subjects (n = 884) underwent capsule colonoscopy followed by conventional colonoscopy (the reference) several weeks later, with an endoscopist blinded to capsule results, at 10 centers in the United States and 6 centers in Israel from June 2011 through April 2012. An unblinded colonoscopy was performed on subjects found to have lesions 6 mm or larger by capsule but not conventional colonoscopy. Results Among the 884 subjects enrolled, 695 (79%) were included in the analysis of capsule performance for all polyps. There were 77 exclusions (9%) for inadequate cleansing and whole-colon capsule transit time fewer than 40 minutes, 45 exclusions (5%) before capsule ingestion, 15 exclusions (2%) after ingestion and before colonoscopy, and 15 exclusions (2%) for site termination. Capsule colonoscopy identified subjects with 1 or more polyps 6 mm or larger with 81% sensitivity (95% confidence interval [CI], 77%-84%) and 93% specificity (95% CI, 91%-95%), and polyps 10 mm or larger with 80% sensitivity (95% CI, 74%-86%) and 97% specificity (95% CI, 96%-98%). Capsule colonoscopy identified subjects with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity (95% CI, 82%-93) and 82% specificity (95% CI, 80%-83%), and 10 mm or larger with 92% sensitivity (95% CI, 82%-97%) and 95% specificity (95% CI, 94%-95%). Sessile serrated polyps and hyperplastic polyps accounted for 26% and 37%, respectively, of false-negative findings from capsule analyses. Conclusions In an average-risk screening population, technically adequate capsule colonoscopy identified individuals with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity and 82% specificity. Capsule performance seems adequate for patients who cannot undergo colonoscopy or who had incomplete colonoscopies. Additional studies are needed to improve capsule detection of serrated lesions. Clinicaltrials.gov number: NCT01372878.

AB - Background & Aims Capsule colonoscopy is a minimally invasive imaging method. We measured the accuracy of this technology in detecting polyps 6 mm or larger in an average-risk screening population. Methods In a prospective study, asymptomatic subjects (n = 884) underwent capsule colonoscopy followed by conventional colonoscopy (the reference) several weeks later, with an endoscopist blinded to capsule results, at 10 centers in the United States and 6 centers in Israel from June 2011 through April 2012. An unblinded colonoscopy was performed on subjects found to have lesions 6 mm or larger by capsule but not conventional colonoscopy. Results Among the 884 subjects enrolled, 695 (79%) were included in the analysis of capsule performance for all polyps. There were 77 exclusions (9%) for inadequate cleansing and whole-colon capsule transit time fewer than 40 minutes, 45 exclusions (5%) before capsule ingestion, 15 exclusions (2%) after ingestion and before colonoscopy, and 15 exclusions (2%) for site termination. Capsule colonoscopy identified subjects with 1 or more polyps 6 mm or larger with 81% sensitivity (95% confidence interval [CI], 77%-84%) and 93% specificity (95% CI, 91%-95%), and polyps 10 mm or larger with 80% sensitivity (95% CI, 74%-86%) and 97% specificity (95% CI, 96%-98%). Capsule colonoscopy identified subjects with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity (95% CI, 82%-93) and 82% specificity (95% CI, 80%-83%), and 10 mm or larger with 92% sensitivity (95% CI, 82%-97%) and 95% specificity (95% CI, 94%-95%). Sessile serrated polyps and hyperplastic polyps accounted for 26% and 37%, respectively, of false-negative findings from capsule analyses. Conclusions In an average-risk screening population, technically adequate capsule colonoscopy identified individuals with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity and 82% specificity. Capsule performance seems adequate for patients who cannot undergo colonoscopy or who had incomplete colonoscopies. Additional studies are needed to improve capsule detection of serrated lesions. Clinicaltrials.gov number: NCT01372878.

KW - Colon Cancer Detection

KW - Colorectal Lesion

KW - Diagnosis Tumor

KW - Neoplasm

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U2 - 10.1053/j.gastro.2015.01.025

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