Original article
Alimentary tract
Multiple-Band Imaging Provides Better Value Than White-light Endoscopy in Detection of Dysplasia in Patients With Barrett's Esophagus

https://doi.org/10.1016/j.cgh.2014.12.007Get rights and content

Background & Aims

Surveillance of patients with Barrett's esophagus usually is performed with standard white-light endoscopy (SDWLE) and the collection of 4 biopsy specimens (every 1–2 cm of the metaplastic segment), based on Seattle protocol. New endoscopic techniques are used routinely, but have been validated based only on low-grade evidence. We aimed to validate the use of high-definition magnifying endoscopy with multiple-band imaging (HDMEMBI) with a targeted biopsy collection for the detection of dysplasia, using SDWLE with quadrant biopsy collection as the reference.

Methods

In a cross-over study, patients with suspected or histologically verified BE (without known neoplasia) seen at a tertiary referral high-volume endoscopy center in Sweden, from November 2009 through November 2012, were assigned randomly to undergo HDMEMBI (n = 63) or SDWLE (n = 47) as the initial procedure, followed by the other procedure in 1 to 4 months. The primary end point was the total number of subjects found to have low-grade dysplasia or high-grade dysplasia (HGD) by each technique. Secondary end points included the number of biopsy specimens taken and the duration of each procedure.

Results

There was no significant difference between groups in diagnostic yield for low-grade dysplasia (14 in HDMEMBI vs 13 in SDWLE) or HGD. Four HGDs were found: 3 using HDMEMBI and 1 using SDWLE. Significantly fewer biopsy specimens were collected during the HDMEMBI procedure (P < .001). The diagnostic yield for the detection of dysplasia per biopsy specimen collected therefore was significantly higher for HDMEMBI than SDWLE (0.25 vs 0.07; P = .018). There was no significant difference in the duration of procedures.

Conclusions

There is no significant difference in the detection of dysplastic lesions using HDMEMBI with targeted collection of biopsy specimens vs SDWLE with 4-quadrant biopsy specimen collection. However, HDMEMBI requires the collection of significantly fewer biopsy specimens, providing better value for health care providers. ClinicalTrials.gov number: NCT01694511.

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)

  • H. Pohl et al.

    The role of overdiagnosis and reclassification in the marked increase of esophageal adenocarcinoma incidence

    J Natl Cancer Inst

    (2005)
  • M. Voutilainen

    Epidemiological trends in oesophageal cancer in the Nordic countries

    Scand J Gastroenterol

    (2008)
  • H. Pohl et al.

    Esophageal adenocarcinoma incidence: are we reaching the peak?

    Cancer Epidemiol Biomarkers Prev

    (2010)
  • 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.

    View full text