A feasibility trial of Acetic acid-targeted Biopsies versus nontargeted quadrantic biopsies during BArrett’s surveillance: the ABBA trial
A feasibility trial of Acetic acid-targeted Biopsies versus nontargeted quadrantic biopsies during BArrett’s surveillance: the ABBA trial
Background The aims of this study were to compare neoplasia detection rates for nontargeted biopsies (Seattle protocol) versus acetic acid-targeted biopsies (Portsmouth protocol) during Barrett’s surveillance and to explore feasibility, patient/clinician experience, acceptance, and barriers/enablers to study participation and implementation of the acetic acid technique.Methods This was a mixed-methods feasibility study including a pilot multicenter, randomized, crossover trial with qualitative interviews. Patients under Barrett’s surveillance with no history of neoplasia were included. Patients underwent two endoscopies, one with each protocol, 8 weeks apart. Outcomes included recruitment and retention rates, neoplasia yield, and number of biopsies.Results 200 patients were recruited from 6 centers, and 174 (87.0 %) underwent both procedures. Neoplasia prevalence was 4.7 % (9/192). High grade dysplasia and cancer were detected with both protocols. Five low grade dysplasias were detected (two with acetic acid, four with nontargeted biopsies; one lesion was detected with both techniques). A total of 2139 biopsies were taken in the nontargeted arm and 226 in the acetic acid arm. Both patients and clinicians found the acetic acid technique acceptable. Based on these data, a noninferiority, tandem, crossover trial would require an estimated 2828 patients.Conclusions We demonstrated the feasibility of performing a crossover endoscopy trial in Barrett’s surveillance. Low neoplasia yield makes this design necessary and qualitative results demonstrated patient and clinician acceptance. The reduced numbers of biopsies suggest that the acetic acid technique could result in cost savings, providing the lack of missed pathology can be proven in a fully powered definitive trial.
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Longcroft-Wheaton, Gaius
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Fogg, Carole
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Chedgy, Fergus
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Kandiah, Kesavan
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Murray, Lisa
ce068eda-64f2-422e-9740-6a0c42220987
Dewey, Ann
bd5669af-d19e-409b-9171-7621abbeb3ea
Barr, Hugh
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Higgins, Bernie
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Poller, David
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Jankowski, Janusz
42c49b2e-cff0-4b13-b072-f3a3ee5452d7
DeCaestecker, John
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Bhandari, Pradeep
185aedf2-3bf7-4125-8eb7-b36e60fbe14c
1 January 2020
Longcroft-Wheaton, Gaius
c81264ad-35a8-4601-a001-d7cfb6357863
Fogg, Carole
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Chedgy, Fergus
143cea93-6dbc-474c-ba84-d70b7396993a
Kandiah, Kesavan
65a0a577-cb0b-4b9c-b1b5-d44d4a266285
Murray, Lisa
ce068eda-64f2-422e-9740-6a0c42220987
Dewey, Ann
bd5669af-d19e-409b-9171-7621abbeb3ea
Barr, Hugh
6aafc927-2548-4372-8d2d-fb361d6d0cd8
Higgins, Bernie
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Poller, David
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Jankowski, Janusz
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DeCaestecker, John
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Bhandari, Pradeep
185aedf2-3bf7-4125-8eb7-b36e60fbe14c
Longcroft-Wheaton, Gaius, Fogg, Carole, Chedgy, Fergus, Kandiah, Kesavan, Murray, Lisa, Dewey, Ann, Barr, Hugh, Higgins, Bernie, Poller, David, Jankowski, Janusz, DeCaestecker, John and Bhandari, Pradeep
(2020)
A feasibility trial of Acetic acid-targeted Biopsies versus nontargeted quadrantic biopsies during BArrett’s surveillance: the ABBA trial.
Endoscopy, 52 (01), .
(doi:10.1055/a-1015-6653).
Abstract
Background The aims of this study were to compare neoplasia detection rates for nontargeted biopsies (Seattle protocol) versus acetic acid-targeted biopsies (Portsmouth protocol) during Barrett’s surveillance and to explore feasibility, patient/clinician experience, acceptance, and barriers/enablers to study participation and implementation of the acetic acid technique.Methods This was a mixed-methods feasibility study including a pilot multicenter, randomized, crossover trial with qualitative interviews. Patients under Barrett’s surveillance with no history of neoplasia were included. Patients underwent two endoscopies, one with each protocol, 8 weeks apart. Outcomes included recruitment and retention rates, neoplasia yield, and number of biopsies.Results 200 patients were recruited from 6 centers, and 174 (87.0 %) underwent both procedures. Neoplasia prevalence was 4.7 % (9/192). High grade dysplasia and cancer were detected with both protocols. Five low grade dysplasias were detected (two with acetic acid, four with nontargeted biopsies; one lesion was detected with both techniques). A total of 2139 biopsies were taken in the nontargeted arm and 226 in the acetic acid arm. Both patients and clinicians found the acetic acid technique acceptable. Based on these data, a noninferiority, tandem, crossover trial would require an estimated 2828 patients.Conclusions We demonstrated the feasibility of performing a crossover endoscopy trial in Barrett’s surveillance. Low neoplasia yield makes this design necessary and qualitative results demonstrated patient and clinician acceptance. The reduced numbers of biopsies suggest that the acetic acid technique could result in cost savings, providing the lack of missed pathology can be proven in a fully powered definitive trial.
Text
A feasibility trial of Acetic acid targeted Biopsies vs non-targeted quadrantic biopsies during BArrett’s surveillance T
- Accepted Manuscript
More information
Accepted/In Press date: 2 September 2019
e-pub ahead of print date: 15 October 2019
Published date: 1 January 2020
Additional Information:
Funding Information:
The study was approved by the National Health Service Research Ethics Committee (Reference number REC 15/SC/0085) and registered at ClinicalTrials.gov (identifier NCT02407392, date of registration 03/04/2015).
Funding Information:
ABBA study group: Andy Lenaghan (Public Member), Mimi McCord (Heartburn Cancer UK), Clive Stokes (Gloucester Trials Unit, Gloucester, UK), Andrew Li (West Sussex NHS trust, Worthing, UK), Peter Basford (West Sussex NHS Trust, St Richard’s Hospital, Chichester), Charlie Gordon (Royal Bourne-mouth and Christchurch Hospitals NHS Trust, Bournemouth, UK), Susi Green (Brighton & Sussex University Hospitals, Brighton, UK), The study was funded by the NIHR Research for Patient Benefit Grant, PB-PG-1013-32045. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.
Publisher Copyright:
© 2020 Georg Thieme Verlag. All rights reserved.
Identifiers
Local EPrints ID: 434904
URI: http://eprints.soton.ac.uk/id/eprint/434904
ISSN: 0013-726X
PURE UUID: 0b4ea8a7-044b-444e-9622-1d52a4a3cf88
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Date deposited: 15 Oct 2019 16:30
Last modified: 16 Mar 2024 08:16
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Contributors
Author:
Gaius Longcroft-Wheaton
Author:
Fergus Chedgy
Author:
Kesavan Kandiah
Author:
Lisa Murray
Author:
Ann Dewey
Author:
Hugh Barr
Author:
Bernie Higgins
Author:
David Poller
Author:
Janusz Jankowski
Author:
John DeCaestecker
Author:
Pradeep Bhandari
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