Late Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia is Rare: Final Report From Ablation in Intestinal Metaplasia Containing Dysplasia Trial

Cary C. Cotton, W. Asher Wolf, Bergein F. Overholt, Nan Li, Charles J. Lightdale, Herbert C. Wolfsen, Sarina Pasricha, Kenneth K. Wang, Nicholas J. Shaheen, Richard E. Sampliner, David E. Fleischer, Virender K. Sharma, Glenn M. Eisen, M (Brian) Fennerty, John Hunter, Mary P. Bronner, John R. Goldblum, Ana E. Bennett, Hiroshi Mashimo, Richard I. RothsteinStuart R. Gordon, Steven A. Edmundowicz, V. Raman Muthusamy, Kenneth J. Chang, Michael B. Kimmey, Stuart J. Spechler, Ali A. Siddiqui, Rhonda F. Souza, Anthony Infantolino, John A. Dumot, Gary W. Falk, Blair A. Jobe, Robert H. Hawes, Brenda J. Hoffman, Prateek Sharma, Amitabh Chak

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

Background & Aims The goal of treatment for Barrett's esophagus (BE) with dysplasia is complete eradication of intestinal metaplasia (CEIM). The long-term durability of CEIM has not been well characterized, so the frequency and duration of surveillance are unclear. We report results from a 5-year follow-up analysis of patients with BE and dysplasia treated by radiofrequency ablation (RFA) in the randomized controlled Ablation of Intestinal Metaplasia Containing Dysplasia (AIM) trial. Methods Participants for the AIM Dysplasia trial (18–80 years old) were recruited from 19 sites in the United States and had endoscopic evidence of non-nodular dysplastic BE ≤8 cm in length. Subjects (n = 127) were randomly assigned (2:1 ratio) to receive either RFA (entire BE segment ablated circumferentially) or a sham endoscopic procedure; patients in the sham group were offered RFA treatment 1 year later, and all patients were followed for 5 years. We collected data on BE recurrence (defined as intestinal metaplasia in the tubular esophagus) and dysplastic BE recurrence among patients who achieved CEIM. We constructed Kaplan-Meier estimates and applied parametric survival analysis to examine proportions of patients without any recurrence and without dysplastic recurrence. Results Of 127 patients in the AIM Dysplasia trial, 119 received RFA and met inclusion criteria. Of those 119, 110 (92%) achieved CEIM. Over 401 person-years of follow-up (mean, 3.6 years per patient; range, 0.2–5.8 years), 35 of 110 (32%) patients had recurrence of BE or dysplasia, and 19 (17%) had dysplasia recurrence. The incidence rate of BE recurrence was 10.8 per 100 person-years overall (95% CI, 7.8–15.0); 8.3 per 100 person-years among patients with baseline low-grade dysplasia (95% CI, 4.9–14.0), and 13.5 per 100 person-years among patients with baseline high-grade dysplasia (95% CI 8.8–20.7). The incidence rate of dysplasia recurrence was 5.2 per 100 person-years overall (95% CI 3.3–8.2); 3.3 per 100 person-years among patients with baseline low-grade dysplasia (95% CI 1.5–7.2), and 7.3 per 100 person-years among patients with baseline high-grade dysplasia (95% CI 4.2–12.5). Neither BE nor dysplasia recurred at a constant rate. There was a greater probability of recurrence in the first year following CEIM than in the following 4 years combined. Conclusions In this analysis of prospective cohort data from the AIM Dysplasia trial, we found BE to recur after CEIM by RFA in almost one third of patients with baseline dysplastic disease; most recurrences occurred during the first year after CEIM. However, patients who achieved CEIM and remained BE free at 1 year after RFA had a low risk of BE recurrence. Studies are needed to determine when surveillance can be decreased or discontinued; our study did not identify any BE or dysplasia recurrence after 4 years of surveillance.

Original languageEnglish (US)
Pages (from-to)681-688.e2
JournalGastroenterology
Volume153
Issue number3
DOIs
StatePublished - Sep 1 2017

Fingerprint

Barrett Esophagus
Metaplasia
Recurrence
Incidence
Kaplan-Meier Estimate
Survival Analysis
Esophagus

Keywords

  • HGD
  • High Grade Dysplasia
  • LGD
  • Long-term Outcome
  • Low Grade Dysplasia
  • Prognostic Factor

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Late Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia is Rare : Final Report From Ablation in Intestinal Metaplasia Containing Dysplasia Trial. / Cotton, Cary C.; Wolf, W. Asher; Overholt, Bergein F.; Li, Nan; Lightdale, Charles J.; Wolfsen, Herbert C.; Pasricha, Sarina; Wang, Kenneth K.; Shaheen, Nicholas J.; Sampliner, Richard E.; Fleischer, David E.; Sharma, Virender K.; Eisen, Glenn M.; Fennerty, M (Brian); Hunter, John; Bronner, Mary P.; Goldblum, John R.; Bennett, Ana E.; Mashimo, Hiroshi; Rothstein, Richard I.; Gordon, Stuart R.; Edmundowicz, Steven A.; Muthusamy, V. Raman; Chang, Kenneth J.; Kimmey, Michael B.; Spechler, Stuart J.; Siddiqui, Ali A.; Souza, Rhonda F.; Infantolino, Anthony; Dumot, John A.; Falk, Gary W.; Jobe, Blair A.; Hawes, Robert H.; Hoffman, Brenda J.; Sharma, Prateek; Chak, Amitabh.

In: Gastroenterology, Vol. 153, No. 3, 01.09.2017, p. 681-688.e2.

Research output: Contribution to journalArticle

Cotton, CC, Wolf, WA, Overholt, BF, Li, N, Lightdale, CJ, Wolfsen, HC, Pasricha, S, Wang, KK, Shaheen, NJ, Sampliner, RE, Fleischer, DE, Sharma, VK, Eisen, GM, Fennerty, MB, Hunter, J, Bronner, MP, Goldblum, JR, Bennett, AE, Mashimo, H, Rothstein, RI, Gordon, SR, Edmundowicz, SA, Muthusamy, VR, Chang, KJ, Kimmey, MB, Spechler, SJ, Siddiqui, AA, Souza, RF, Infantolino, A, Dumot, JA, Falk, GW, Jobe, BA, Hawes, RH, Hoffman, BJ, Sharma, P & Chak, A 2017, 'Late Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia is Rare: Final Report From Ablation in Intestinal Metaplasia Containing Dysplasia Trial', Gastroenterology, vol. 153, no. 3, pp. 681-688.e2. https://doi.org/10.1053/j.gastro.2017.05.044
Cotton, Cary C. ; Wolf, W. Asher ; Overholt, Bergein F. ; Li, Nan ; Lightdale, Charles J. ; Wolfsen, Herbert C. ; Pasricha, Sarina ; Wang, Kenneth K. ; Shaheen, Nicholas J. ; Sampliner, Richard E. ; Fleischer, David E. ; Sharma, Virender K. ; Eisen, Glenn M. ; Fennerty, M (Brian) ; Hunter, John ; Bronner, Mary P. ; Goldblum, John R. ; Bennett, Ana E. ; Mashimo, Hiroshi ; Rothstein, Richard I. ; Gordon, Stuart R. ; Edmundowicz, Steven A. ; Muthusamy, V. Raman ; Chang, Kenneth J. ; Kimmey, Michael B. ; Spechler, Stuart J. ; Siddiqui, Ali A. ; Souza, Rhonda F. ; Infantolino, Anthony ; Dumot, John A. ; Falk, Gary W. ; Jobe, Blair A. ; Hawes, Robert H. ; Hoffman, Brenda J. ; Sharma, Prateek ; Chak, Amitabh. / Late Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia is Rare : Final Report From Ablation in Intestinal Metaplasia Containing Dysplasia Trial. In: Gastroenterology. 2017 ; Vol. 153, No. 3. pp. 681-688.e2.
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title = "Late Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia is Rare: Final Report From Ablation in Intestinal Metaplasia Containing Dysplasia Trial",
abstract = "Background & Aims The goal of treatment for Barrett's esophagus (BE) with dysplasia is complete eradication of intestinal metaplasia (CEIM). The long-term durability of CEIM has not been well characterized, so the frequency and duration of surveillance are unclear. We report results from a 5-year follow-up analysis of patients with BE and dysplasia treated by radiofrequency ablation (RFA) in the randomized controlled Ablation of Intestinal Metaplasia Containing Dysplasia (AIM) trial. Methods Participants for the AIM Dysplasia trial (18–80 years old) were recruited from 19 sites in the United States and had endoscopic evidence of non-nodular dysplastic BE ≤8 cm in length. Subjects (n = 127) were randomly assigned (2:1 ratio) to receive either RFA (entire BE segment ablated circumferentially) or a sham endoscopic procedure; patients in the sham group were offered RFA treatment 1 year later, and all patients were followed for 5 years. We collected data on BE recurrence (defined as intestinal metaplasia in the tubular esophagus) and dysplastic BE recurrence among patients who achieved CEIM. We constructed Kaplan-Meier estimates and applied parametric survival analysis to examine proportions of patients without any recurrence and without dysplastic recurrence. Results Of 127 patients in the AIM Dysplasia trial, 119 received RFA and met inclusion criteria. Of those 119, 110 (92{\%}) achieved CEIM. Over 401 person-years of follow-up (mean, 3.6 years per patient; range, 0.2–5.8 years), 35 of 110 (32{\%}) patients had recurrence of BE or dysplasia, and 19 (17{\%}) had dysplasia recurrence. The incidence rate of BE recurrence was 10.8 per 100 person-years overall (95{\%} CI, 7.8–15.0); 8.3 per 100 person-years among patients with baseline low-grade dysplasia (95{\%} CI, 4.9–14.0), and 13.5 per 100 person-years among patients with baseline high-grade dysplasia (95{\%} CI 8.8–20.7). The incidence rate of dysplasia recurrence was 5.2 per 100 person-years overall (95{\%} CI 3.3–8.2); 3.3 per 100 person-years among patients with baseline low-grade dysplasia (95{\%} CI 1.5–7.2), and 7.3 per 100 person-years among patients with baseline high-grade dysplasia (95{\%} CI 4.2–12.5). Neither BE nor dysplasia recurred at a constant rate. There was a greater probability of recurrence in the first year following CEIM than in the following 4 years combined. Conclusions In this analysis of prospective cohort data from the AIM Dysplasia trial, we found BE to recur after CEIM by RFA in almost one third of patients with baseline dysplastic disease; most recurrences occurred during the first year after CEIM. However, patients who achieved CEIM and remained BE free at 1 year after RFA had a low risk of BE recurrence. Studies are needed to determine when surveillance can be decreased or discontinued; our study did not identify any BE or dysplasia recurrence after 4 years of surveillance.",
keywords = "HGD, High Grade Dysplasia, LGD, Long-term Outcome, Low Grade Dysplasia, Prognostic Factor",
author = "Cotton, {Cary C.} and Wolf, {W. Asher} and Overholt, {Bergein F.} and Nan Li and Lightdale, {Charles J.} and Wolfsen, {Herbert C.} and Sarina Pasricha and Wang, {Kenneth K.} and Shaheen, {Nicholas J.} and Sampliner, {Richard E.} and Fleischer, {David E.} and Sharma, {Virender K.} and Eisen, {Glenn M.} and Fennerty, {M (Brian)} and John Hunter and Bronner, {Mary P.} and Goldblum, {John R.} and Bennett, {Ana E.} and Hiroshi Mashimo and Rothstein, {Richard I.} and Gordon, {Stuart R.} and Edmundowicz, {Steven A.} and Muthusamy, {V. Raman} and Chang, {Kenneth J.} and Kimmey, {Michael B.} and Spechler, {Stuart J.} and Siddiqui, {Ali A.} and Souza, {Rhonda F.} and Anthony Infantolino and Dumot, {John A.} and Falk, {Gary W.} and Jobe, {Blair A.} and Hawes, {Robert H.} and Hoffman, {Brenda J.} and Prateek Sharma and Amitabh Chak",
year = "2017",
month = "9",
day = "1",
doi = "10.1053/j.gastro.2017.05.044",
language = "English (US)",
volume = "153",
pages = "681--688.e2",
journal = "Gastroenterology",
issn = "0016-5085",
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TY - JOUR

T1 - Late Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia is Rare

T2 - Final Report From Ablation in Intestinal Metaplasia Containing Dysplasia Trial

AU - Cotton, Cary C.

AU - Wolf, W. Asher

AU - Overholt, Bergein F.

AU - Li, Nan

AU - Lightdale, Charles J.

AU - Wolfsen, Herbert C.

AU - Pasricha, Sarina

AU - Wang, Kenneth K.

AU - Shaheen, Nicholas J.

AU - Sampliner, Richard E.

AU - Fleischer, David E.

AU - Sharma, Virender K.

AU - Eisen, Glenn M.

AU - Fennerty, M (Brian)

AU - Hunter, John

AU - Bronner, Mary P.

AU - Goldblum, John R.

AU - Bennett, Ana E.

AU - Mashimo, Hiroshi

AU - Rothstein, Richard I.

AU - Gordon, Stuart R.

AU - Edmundowicz, Steven A.

AU - Muthusamy, V. Raman

AU - Chang, Kenneth J.

AU - Kimmey, Michael B.

AU - Spechler, Stuart J.

AU - Siddiqui, Ali A.

AU - Souza, Rhonda F.

AU - Infantolino, Anthony

AU - Dumot, John A.

AU - Falk, Gary W.

AU - Jobe, Blair A.

AU - Hawes, Robert H.

AU - Hoffman, Brenda J.

AU - Sharma, Prateek

AU - Chak, Amitabh

PY - 2017/9/1

Y1 - 2017/9/1

N2 - Background & Aims The goal of treatment for Barrett's esophagus (BE) with dysplasia is complete eradication of intestinal metaplasia (CEIM). The long-term durability of CEIM has not been well characterized, so the frequency and duration of surveillance are unclear. We report results from a 5-year follow-up analysis of patients with BE and dysplasia treated by radiofrequency ablation (RFA) in the randomized controlled Ablation of Intestinal Metaplasia Containing Dysplasia (AIM) trial. Methods Participants for the AIM Dysplasia trial (18–80 years old) were recruited from 19 sites in the United States and had endoscopic evidence of non-nodular dysplastic BE ≤8 cm in length. Subjects (n = 127) were randomly assigned (2:1 ratio) to receive either RFA (entire BE segment ablated circumferentially) or a sham endoscopic procedure; patients in the sham group were offered RFA treatment 1 year later, and all patients were followed for 5 years. We collected data on BE recurrence (defined as intestinal metaplasia in the tubular esophagus) and dysplastic BE recurrence among patients who achieved CEIM. We constructed Kaplan-Meier estimates and applied parametric survival analysis to examine proportions of patients without any recurrence and without dysplastic recurrence. Results Of 127 patients in the AIM Dysplasia trial, 119 received RFA and met inclusion criteria. Of those 119, 110 (92%) achieved CEIM. Over 401 person-years of follow-up (mean, 3.6 years per patient; range, 0.2–5.8 years), 35 of 110 (32%) patients had recurrence of BE or dysplasia, and 19 (17%) had dysplasia recurrence. The incidence rate of BE recurrence was 10.8 per 100 person-years overall (95% CI, 7.8–15.0); 8.3 per 100 person-years among patients with baseline low-grade dysplasia (95% CI, 4.9–14.0), and 13.5 per 100 person-years among patients with baseline high-grade dysplasia (95% CI 8.8–20.7). The incidence rate of dysplasia recurrence was 5.2 per 100 person-years overall (95% CI 3.3–8.2); 3.3 per 100 person-years among patients with baseline low-grade dysplasia (95% CI 1.5–7.2), and 7.3 per 100 person-years among patients with baseline high-grade dysplasia (95% CI 4.2–12.5). Neither BE nor dysplasia recurred at a constant rate. There was a greater probability of recurrence in the first year following CEIM than in the following 4 years combined. Conclusions In this analysis of prospective cohort data from the AIM Dysplasia trial, we found BE to recur after CEIM by RFA in almost one third of patients with baseline dysplastic disease; most recurrences occurred during the first year after CEIM. However, patients who achieved CEIM and remained BE free at 1 year after RFA had a low risk of BE recurrence. Studies are needed to determine when surveillance can be decreased or discontinued; our study did not identify any BE or dysplasia recurrence after 4 years of surveillance.

AB - Background & Aims The goal of treatment for Barrett's esophagus (BE) with dysplasia is complete eradication of intestinal metaplasia (CEIM). The long-term durability of CEIM has not been well characterized, so the frequency and duration of surveillance are unclear. We report results from a 5-year follow-up analysis of patients with BE and dysplasia treated by radiofrequency ablation (RFA) in the randomized controlled Ablation of Intestinal Metaplasia Containing Dysplasia (AIM) trial. Methods Participants for the AIM Dysplasia trial (18–80 years old) were recruited from 19 sites in the United States and had endoscopic evidence of non-nodular dysplastic BE ≤8 cm in length. Subjects (n = 127) were randomly assigned (2:1 ratio) to receive either RFA (entire BE segment ablated circumferentially) or a sham endoscopic procedure; patients in the sham group were offered RFA treatment 1 year later, and all patients were followed for 5 years. We collected data on BE recurrence (defined as intestinal metaplasia in the tubular esophagus) and dysplastic BE recurrence among patients who achieved CEIM. We constructed Kaplan-Meier estimates and applied parametric survival analysis to examine proportions of patients without any recurrence and without dysplastic recurrence. Results Of 127 patients in the AIM Dysplasia trial, 119 received RFA and met inclusion criteria. Of those 119, 110 (92%) achieved CEIM. Over 401 person-years of follow-up (mean, 3.6 years per patient; range, 0.2–5.8 years), 35 of 110 (32%) patients had recurrence of BE or dysplasia, and 19 (17%) had dysplasia recurrence. The incidence rate of BE recurrence was 10.8 per 100 person-years overall (95% CI, 7.8–15.0); 8.3 per 100 person-years among patients with baseline low-grade dysplasia (95% CI, 4.9–14.0), and 13.5 per 100 person-years among patients with baseline high-grade dysplasia (95% CI 8.8–20.7). The incidence rate of dysplasia recurrence was 5.2 per 100 person-years overall (95% CI 3.3–8.2); 3.3 per 100 person-years among patients with baseline low-grade dysplasia (95% CI 1.5–7.2), and 7.3 per 100 person-years among patients with baseline high-grade dysplasia (95% CI 4.2–12.5). Neither BE nor dysplasia recurred at a constant rate. There was a greater probability of recurrence in the first year following CEIM than in the following 4 years combined. Conclusions In this analysis of prospective cohort data from the AIM Dysplasia trial, we found BE to recur after CEIM by RFA in almost one third of patients with baseline dysplastic disease; most recurrences occurred during the first year after CEIM. However, patients who achieved CEIM and remained BE free at 1 year after RFA had a low risk of BE recurrence. Studies are needed to determine when surveillance can be decreased or discontinued; our study did not identify any BE or dysplasia recurrence after 4 years of surveillance.

KW - HGD

KW - High Grade Dysplasia

KW - LGD

KW - Long-term Outcome

KW - Low Grade Dysplasia

KW - Prognostic Factor

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