Original ResearchClinical—Alimentary TractConsensus Statements for Management of Barrett's Dysplasia and Early-Stage Esophageal Adenocarcinoma, Based on a Delphi Process
Section snippets
Methods
The specific population under consideration consisted of adults aged 18 years or older with a diagnosis of BE plus LGD, HGD, or early EA, the latter being defined as intramucosal EA (T1m) or superficial submucosal EA (T1sm1). We used a Delphi process to develop consensus statements for LGD/HGD/early EA. This approach combines the principles of evidence-based medicine supported by systematic literature reviews with the use of an iterative anonymous voting process. This software program permitted
Results
The initial stage was development of statements followed by a comprehensive literature review. Eventually, 4 in-person meetings followed by 4 rounds of consensus voting resulted in consensus (80% of respondents strongly agree or agree with reservation) being achieved in 81 of 91 statements. The respondents were asked to choose 1 of the following for each statement; agree strongly (A+), agree with reservation (A), undecided (U), disagree (D) or disagree strongly (D+). Although evidence-based
Discussion
We focused on statements concerning HGD and EA as evidence relating to LGD is particularly weak. The management of HGD and EA of the esophagus is heterogeneous and the clinician's perception of the available evidence is one major determinant of this variation in practice. The relatively poor quality of data relating to dysplasia in BE is emphasized by 46 statements having a very low or low level and 38 having moderate or high levels of evidence. However, in many cases, it is unlikely that
Acknowledgments
We thank Marion Lawlor of University Hospitals of Leicester, National Health Service Trust for administrative support and accounts. In addition, others provided essential core support, including Jan Lilleyman (administration). We would also like to thank the various funders for their contributions, which enabled this process to occur completely independently of pharmaceutical support. Literature searches were designed by LUCID Health, University of Leeds, UK (Pat Spoor and Ros Dunlevey). Peer
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Conflicts of interest These authors disclose the following: Janusz Jankowski is a paid consultant to AstraZeneca UK and Almirall and a grant holder from FALK. He is Chief Investigator for the AspECT and CHoPIN trials, which are supported by AstraZeneca. Cathy Bennett is the proprietor of Systematic Research Ltd and received a consultancy fee for her work on this consensus document. Paul Moayyedi is a consultant to AstraZeneca. Nimish Vakil is a consultant to Astra Zeneca, Takeda, Ironwood, Restech, and Orexo. Robert Ganz is the primary inventor and the cofounder of BÂRRX Medical, holds equity in the company, and serves as a paid consultant. Peter Kahrilas performs ad hoc consulting for AstraZeneca, Eisai, EndoGastric Solutions, and Ironwood, and serves on advisory boards for Torax and Reckitt Benckiser. Michio Hongo is a consultant to Abbott Japan, AstraZeneca Japan, AstellasPharma, Daiichi-Sankyo, Dainippon Sumitomo Pharma, Eisai, Kissei Pharmaceutical, Takeda Pharmaceutical, Scampo Pharma, and Zelia Pharmaceutical. Yvonne Romero is a consultant to AstraZeneca, Santarus, Takeda, Kala, Pfizer, and Aptalis. David Armstrong has received one or more of the following: educational and research grants, honoraria, consulting fees, and related travel expenses from Abbott Laboratories, AltanaPharma, AstraZeneca, Axcan, Eisai Limited, Gilead, Janssen Ortho Inc, Merck, NPS Pharmaceuticals, Nycomed, Olympus Canada Inc, Pentax Medical Inc, Pfizer, Proctor & Gamble, Schering-Plough, Shire Canada, Takeda Canada, Warner-Chilcott, and XenoPort Inc. Richard Sampliner received a BÂRRX research grant. Oliver Pech is a consultant to Hitachi Medical, Fujinon, Norgine, and AstraZeneca. Jaroslaw Regula is a consultant to Abbott, Astellas, AstraZeneca, Krka, MSD, Polpharma, Sandoz, and Warner-Chilcott.M. Brian Fennerty is a consultant for Aptalis, Oncoscope, and Meridian Bioscience. Nicholas Talley has had grant support from Falk, Forest, Janssen, and Takeda, has been a consultant for ARYx, Astellas, Astra Zeneca, Boehringer Ingleheim, Care Capitol, ConCERT, Edusa, Falk, Focus Medical Communications, Forest, Ironwood, Janssen, Johnson & Johnson, Meritage, NicOx, Novartis, Prometheus, Salix, Sanofi-Adventis, Shire, Tranzyme, Theravance, XenoPort, and Zeria, and is a key opinion leader for Doyen Medical Inc. John de Caestecker is Chair of AspECT Trial Management Group, which is AstraZeneca supported. Jacques Bergman is a consultant for Boston Scientific and has research support from BÂRRX Medical, Olympus, and Cook. Stephen Attwood is on the aspect trial management committee, which is AstraZeneca supported. JeanPaul Galmiche is a consultant and speaker for Given Imaging, Mauna Kea Technologies, Shire, Norgine, and Xenoport. His institution has received research grants from AstraZeneca, Janssen Cilag France, ADDEX, and Pentax. Laurence Lovat is on the Advisory Board of Ninepoint Medical and performed ad hoc consulting for Given Imaging and research support for Axcan Pharma, DUSA Pharmaceuticals, and BÂRRX. Peter Watson is a member of AspECT Trial Management Group, which is AstraZeneca sponsored. Kenneth Wang is a consultant to BÂRRX, Ironwood Pharma, CDX Diagnostics, Pinnacle Pharma, and CSA. David Johnston has received speaker's fees and support to attend educational meetings from AstraZeneca. Krish Ragunath received research support, educational grants and speaker honoraria from Olympus Keymed, Cook Medical and BÂRRX Medical. Stuart Gittens is managing director of ECD solutions web data handling company. The remaining authors disclose no conflicts.
Funding Funding has been received from the International Society of Diseases of the Esophagus ($3500), British Society of Gastroenterology (£2500), American College of Gastroenterology ($2000), American Gastroenterological Association ($2000), American Society for Gastrointestinal Endoscopy ($2000), Association of Upper Gastrointestinal Surgeons (£1000), Fight Oesophageal Reflux Together (£1000), German Society of Endoscopy (€2000), Netherlands Association of Hepatogastroenterologists (€1100), and Oesophageal Cancer Fund of Ireland (€3000).