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Endoscopic Detection of Dysplasia in Barrett's Esophagus

High Resolution Magnifying Endoscopy and Contrast Enhanced Imaging Versus Standard White Light Endoscopy for the Detection of Dysplasia in Barrett's Esophagus. A Prospective Blinded Cross-over Study.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01694511
Enrollment
111
Registered
2012-09-27
Start date
2009-11-30
Completion date
2013-01-31
Last updated
2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's Esophagus

Keywords

Endoscopy, Gastrointestinal

Brief summary

The purpose of this study is to determine whether High Resolution Magnification Endoscopy (HRME) and Computed Virtual Chromoendoscopy (CVC) with targeted biopsies is superior to conventional white light endoscopy (WLE) with 4 quadrant biopsies of the metaplastic epithelium every 1-2 cm (Seattle Protocol) for detection of pre-malignant lesions in patients with Barrett's Esophagus (BE).

Detailed description

BE is a metaplastic mucosal transformation adjacent to the esophagogastric junction, due to chronic reflux of gastric juices, Gastro Esophageal Reflux Disease (GERD). The continuous esophageal exposure of acid- and/or bile- containing fluids leads, untreated, to chronic esophagitis. In certain patients a mucosal transformation takes place. The epithelium in the distal part of esophagus is transferred from squamous into a more intestinal-like mucosa, called Specialized Intestinal Metaplasia (SIM).Patients with BE is believed to run a higher risk of developing esophageal adenocarcinoma (EAC). EAC is a rare condition in the western society, but the prevalence is rising compared with other malignancies, and a substantial increase has been seen during the last four decades. The pathogenesis of cancer development is believed to be that SIM in some patients can undergo dysplastic transformation, from low to high grade, and from high grade dysplasia (HGD) develop into AC. Advanced EAC is associated to a poor prognosis whereas HGD or carcinoma in situ may be treated endoscopically with a favorable outcome. The need for surveillance endoscopy in order to discover early cancer lesions available to curable treatment is up against cost effectiveness and evidence level regarding screening. The conventional endoscopic (CE) surveillance algorithm for BE is standard WLE and 4 quadrant biopsies of the metaplastic epithelium every 1-2 cm above the esophagogastric junction. The development of advanced endoscopic techniques have made it possible to distinguish minimal polypoid lesions but also the microvasculature and pit-pattern structures that in certain grading systems have been associated to presence of dysplasia. Attempts have been made in exploring the benefits of advanced endoscopic technologies against standard WLE. Feasibility-studies suggests that the new techniques improves the biopsy-yield for dysplasia, however only a limited number of prospective studies exist. Study aim: To determine whether HRME and CVC with targeted biopsies is superior to conventional WLE with 4 quadrant biopsies of the metaplastic epithelium every 1-2 cm (Seattle Protocol) for detection of pre-malignant lesions in patients with BE. Primary endpoint: Incidence of detected dysplasia by each endoscopic technique. Secondary endpoints: 1.The yield of low- and/or high-grade dysplasia by each endoscopic technique. 2.The number of biopsies taken and the duration of the different endoscopic techniques. 3.The endoscopic prediction capability of present dysplasia compared to histopathology for HRME. Statistical power: Based on the primary endpoint, the amount of dysplasia in a Barrett-population is approximately 10%. We calculated a raise in positive yield with using advanced endoscopy to 8%. At p\<0,05 and a power of 80% the need for 105 patients. Setting: Tertiary referral high volume endoscopy center at Sahlgrenska University Hospital, Sweden.

Interventions

PROCEDUREHRME+CVC

High resolution magnification endoscopy with computed virtual chromoendoscopy and directed biopsy

PROCEDUREconventional endoscopy

Conventional white light endoscopy with four-quadrant biopsy

Sponsors

Sahlgrenska University Hospital
CollaboratorOTHER
Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Presence of specialized intestinal metaplasia in biopsies from the esophagus

Exclusion criteria

* Dysplasia or cancer

Design outcomes

Primary

MeasureTime frame
Incidence of detected dysplasia by each endoscopic technique.Up to 36 months.

Secondary

MeasureTime frame
The yield of low- and/or high-grade dysplasia by each endoscopic technique.Up to 36 months.
The number of biopsies taken and the duration of the different endoscopic techniques.Up to 36 months.

Other

MeasureTime frame
The endoscopic prediction capability of present dysplasia compared to histopathology for HRME.Up to 36 months.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026