Subscribe to RSS
DOI: 10.1055/a-1015-6653
A feasibility trial of Acetic acid-targeted Biopsies versus nontargeted quadrantic biopsies during BArrett’s surveillance: the ABBA trial
Publication History
submitted 18 May 2019
accepted after revision 02 September 2019
Publication Date:
15 October 2019 (online)
![](https://www.thieme-connect.de/media/endoscopy/202001/lookinside/thumbnails/17960_10-1055-a-1015-6653-1.jpg)
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.
*
-
References
- 1 Office for National Statistics, ONS. Cancer registration statistics, England: 2016. 2018 Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/bulletins/cancerregistrationstatisticsengland/final2016
- 2 Cancer Research UK. Statistics by cancer type 2018 [13th December 2018]. Available from: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/oesophageal-cancer
- 3 Jankowski JA. Progression to cancer and risk factors. In: Watson A, Heading RC, Shepherd NA. British Society of Gastroenterology Guidelines for the diagnosis and management of Barrett’s columnar-lined oesophagus. London: BSG; 2005: 21-23
- 4 Coleman MP, Forman D, Bryant H. et al. Cancer survival in Australia, Canada, Denmark, Norway, Sweden, and the UK, 1995–2007 (the International Cancer Benchmarking Partnership): an analysis of population-based cancer registry data. Lancet 2011; 377: 127-138
- 5 Pech O, Gossner L, Manner H. et al. Prospective evaluation of the macroscopic types and location of early Barrett’s neoplasia in 380 lesions. Endoscopy 2007; 39: 588-593
- 6 Kariv R, Plesec TP, Goldblum JR. et al. The Seattle protocol does not more reliably predict the detection of cancer at the time of esophagectomy than a less intensive surveillance protocol. Clin Gastroenterol Hepatol 2009; 7: 653-658
- 7 Shaheen NJ, Falk GW, Iyer PG. et al. ACG Clinical Guideline: Diagnosis and management of Barrett’s esophagus. Am J Gastroenterol 2016; 111: 30-50
- 8 Spechler SJ, Sharma P, Souza RF. et al. American Gastroenterological Association technical review on the management of Barrett’s esophagus. Gastroenterology 2011; 140: e18-52
- 9 Abrams JA, Kapel RC, Lindberg GM. et al. Adherence to biopsy guidelines for Barrett’s esophagus surveillance in the community setting in the United States. Clin Gastroenterol Hepatol 2009; 7: 736-742
- 10 Curvers WL, van den Broek FJC, Reitsma JB. et al. Systematic review of narrow-band imaging for the detection and differentiation of abnormalities in the esophagus and stomach (with video). Gastrointest Endosc 2009; 69: 307-317
- 11 Fitzgerald RC, di Pietro M, Ragunath K. et al. British Society of Gastroenterology guidelines on the diagnosis and management of Barrett’s oesophagus. Gut 2014; 63: 7-42
- 12 Bennett C, Moayyedi P, Corley DA. et al. BOB CAT: a large-scale review and delphi consensus for management of Barrett’s esophagus with no dysplasia, indefinite for, or low-grade dysplasia. Am J Gastroenterol 2015; 110: 662-682
- 13 Levine DS, Blount PL, Rudolph RE. et al. Safety of a systematic endoscopic biopsy protocol in patients with Barrett’s esophagus. Am J Gastroenterol 2000; 95: 1152-1157
- 14 Lambert R, Rey JF, Sankaranarayanan R. Magnification and chromoscopy with the acetic acid test. Endoscopy 2003; 35: 437-445
- 15 Longcroft-Wheaton G, Brown J, Basford P. et al. Duration of acetowhitening as a novel objective tool for diagnosing high risk neoplasia in Barrett’s esophagus: a prospective cohort trial. Endoscopy 2013; 45: 426-432
- 16 Longcroft-Wheaton G, Duku M, Mead R. et al. Acetic acid spray is an effective tool for the endoscopic detection of neoplasia in patients with Barrett’s esophagus. Clin Gastroenterol Hepatol 2010; 8: 843-847
- 17 Pohl J, Pech O, May A. et al. Incidence of macroscopically occult neoplasias in Barrett’s esophagus: are random biopsies dispensable in the era of advanced endoscopic imaging?. Am J Gastroenterol 2010; 105: 2350-2356
- 18 Thosani N, Abu Dayyeh BK, Sharma P. et al. ASGE Technology Committee systematic review and meta-analysis assessing the ASGE Preservation and Incorporation of Valuable Endoscopic Innovations thresholds for adopting real-time imaging-assisted endoscopic targeted biopsy during endoscopic surveillance. Gastrointest Endosc 2016; 83: 684-698
- 19 Chedgy F, Fogg C, Kandiah K. et al. Acetic acid-guided biopsies in Barrett’s surveillance for neoplasia detection versus non-targeted biopsies (Seattle protocol): a feasibility study for a randomized tandem endoscopy trial. The ABBA study. Endosc Int Open 2018; 6: E43-E50
- 20 Kandiah K, Chedgy FJQ, Subramaniam S. et al. International development and validation of a classification system for the identification of Barrett’s neoplasia using acetic acid chromoendoscopy: the Portsmouth acetic acid classification (PREDICT). Gut 2018; 67: 2085-2091
- 21 Chedgy FJQ, Kandiah K, Barr H. et al. Development and validation of a training module on the use of acetic acid for the detection of Barrett’s neoplasia. Endoscopy 2017; 49: 121-129
- 22 di Pietro M, Fitzgerald RC. BSG Barrett’s Guidelines Working Group. Revised British Society of Gastroenterology recommendation on the diagnosis and management of Barrett’s oesophagus with low-grade dysplasia. Gut 2018; 67: 392-393
- 23 Kaye PV, Ilyas M, Soomro I. et al. Dysplasia in Barrett’s oesophagus: p53immunostaining is more reproducible than haematoxylin and eosin diagnosis and improves overall reliability, while grading is poorly reproducible. Histopathology 2016; 69: 431-440
- 24 Chow SC, Shao J, Wang H. Sample size calculation in clinical research. New York: Marcel Dekker; 2008
- 25 Vennalaganti P, Kanakadandi V, Goldblum JR. et al. Discordance among pathologists in the United States and Europe in diagnosis of low-grade dysplasia for patients with Barrett’s esophagus. Gastroenterology 2017; 152: 564-570
- 26 Krishnamoorthi R, Lewis JT, Krishna M. et al. Predictors of progression in Barrett’s esophagus with low-grade dysplasia: results from a multicenter prospective BE registry. Am J Gastroenterol 2017; 112: 867-873
- 27 Vaughan TL, Fitzgerald RC. Precision prevention of oesophageal adenocarcinoma. Nat Rev Gastroenterol Hepatol 2015; 12: 243-248