Original articleAlimentary tractMultiple-Band Imaging Provides Better Value Than White-light Endoscopy in Detection of Dysplasia in Patients With Barrett's Esophagus
Section snippets
Study Design and Ethics
The study was designed as a prospective, single-center, investigator-blinded, randomized, cross-over trial with the aim of comparing the yield of dysplasia using advanced endoscopy with a targeted biopsy regimen with that of standard WLE and random 4-quadrant biopsies. The study was performed in accordance with the Declaration of Helsinki and was approved by the Regional Ethical Review Board in Gothenburg, Sweden (no 373-09). All study participants were informed orally and in writing, and
Patient Flow
A total of 255 referred patients were assessed for eligibility and 111 patients were included in the study. One patient withdrew consent before randomization. By using the 120 sealed envelopes, 59 patients were randomized to HDMEMBI and targeted biopsies and 51 patients were randomized to SDWLE and biopsies according to the Seattle protocol as the initial investigation procedure. Because of rescheduling of appointed endoscopies, the actual proportion became 63 vs 47 patients. A total of 107
Discussion
The power calculation in this study required 116 patients to be enrolled, and 105 patients should have completed the study. The inclusion period was 3 years. In 2012, there was a substantial change in health care financial priorities, making inclusion more difficult. We therefore were obliged to stop inclusion at 111 patients. Because of the low drop-out frequency, with 107 patients completing the trial, the analysis still was within the range of the prestudy power analysis. Twenty-three
Acknowledgments
The authors are very grateful for the skilled assistance of the following research nurses: My Engström, Niclas Björnfot, Diana Lustgarten, and Eva-Lotta Een. The authors also thank the staff of the Endoscopy Department for their kind support.
References (27)
- et al.
A critical review of the diagnosis and management of Barrett's esophagus: the AGA Chicago Workshop
Gastroenterology
(2004) - et al.
The development and validation of an endoscopic grading system for Barrett's esophagus: the Prague C & M criteria
Gastroenterology
(2006) - et al.
Endoscopic video autofluorescence imaging may improve the detection of early neoplasia in patients with Barrett's esophagus
Gastrointest Endosc
(2005) - et al.
In vivo histology of Barrett's esophagus and associated neoplasia by confocal laser endomicroscopy
Clin Gastroenterol Hepatol
(2006) - et al.
Methylene blue-directed biopsies improve detection of intestinal metaplasia and dysplasia in Barrett's esophagus
Gastrointest Endosc
(2000) - et al.
Comparison of methylene blue-directed biopsies and conventional biopsies in the detection of intestinal metaplasia and dysplasia in Barrett's esophagus: a preliminary study
Gastrointest Endosc
(2001) - et al.
Randomized crossover study that used methylene blue or random 4-quadrant biopsy for the diagnosis of dysplasia in Barrett's esophagus
Gastrointest Endosc
(2006) - et al.
The American Society for Gastrointestinal Endoscopy PIVI (preservation and incorporation of valuable endoscopic innovations) on imaging in Barrett's esophagus
Gastrointest Endosc
(2012) - et al.
Reproducibility of the diagnosis of dysplasia in Barrett esophagus: a reaffirmation
Hum Pathol
(2001) - et al.
Barrett's esophagus is frequently overdiagnosed in clinical practice: results of the Barrett's Esophagus Endoscopic Revision (BEER) study
Gastrointest Endosc
(2014)
The role of overdiagnosis and reclassification in the marked increase of esophageal adenocarcinoma incidence
J Natl Cancer Inst
Epidemiological trends in oesophageal cancer in the Nordic countries
Scand J Gastroenterol
Esophageal adenocarcinoma incidence: are we reaching the peak?
Cancer Epidemiol Biomarkers Prev
Cited by (0)
Conflicts of interest The authors disclose no conflicts.
Funding Supported by the Health Technology Assessment Center at Sahlgrenska University Hospital, hospital based research grants (L.F. and A.E.), and from the administration of the Western Region of Sweden.