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Endoscopic Tri-Modal Imaging for the Detection of High-Grade Dysplasia and Early Adenocarcinoma in Patients With Barrett's Esophagus: A Randomized Crossover Multi-center Study


N/A
18 Years
85 Years
Not Enrolling
Both
Barretts Esophagus, High Grade Dysplasia, Early Esophageal Adenocarcinoma

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Trial Information

Endoscopic Tri-Modal Imaging for the Detection of High-Grade Dysplasia and Early Adenocarcinoma in Patients With Barrett's Esophagus: A Randomized Crossover Multi-center Study


Patients with Barrett's esophagus are advised to undergo periodic endoscopic surveillance
with random biopsies in an attempt to identify high-grade dysplasia (HGD) or early
adenocarcinoma (ACA) at a time when intervention can be curative. This approach, however,
can be time-consuming and is hindered by low sampling yield and random sampling error.
Endoscopic Tri-Modal Imaging (ETMI) is a novel diagnostic modality that encompasses three
advanced imaging features in one system: high-resolution endoscopy (HRE), autofluorescence
imaging (AFI) and narrow-band imaging (NBI). HRE and AFI provide a bird's-eye view of 'red
flag' areas which are then assessed by NBI for focused and more specific tissue
characterization. The aim of this prospective, multi-center study is to compare the
diagnostic performance of ETMI with that of standard white-light endoscopy (WLE) for
identifying high-grade dysplasia (HGD) and early adenocarcinoma (ACA) in BE. A total of 84
BE patients will be recruited for the study and they will undergo both ETMI and WLE
examinations in a randomized, crossover fashion. Standard surveillance biopsies and
ETMI-targeted biopsies will be performed. The primary outcome will compare the number of
patients and lesions with HGD or early ACA detected with WLE and ETMI. It is anticipated
that ETMI will enhance the detection of high-grade Barrett's lesions relative to WLE.


Inclusion Criteria:



1. Age > 18 years

2. Prior diagnosis of BE, defined as the presence of columnar-lined epithelium in the
distal tubular esophagus with specialised intestinal metaplasia on histological
investigation

3. Prior diagnosis of HGD or early ACA that was endoscopically inconspicuous according
to the referring source

4. A minimum Barrett's length of C>2M>2 or C<2M>4 according to the Prague C&M
classification for the endoscopic appearance of BE

5. Ability to provide written informed consent

Exclusion Criteria:

1. Description of a visibly suspicious lesion within the Barrett's segment according to
the referring source

2. Presence of a type 0-I or type 0-III lesion, or a lesion that, according to the
discretion of the endoscopist, does not allow delay in intervention for a period of 6
weeks (minimum interval between the two crossover endoscopies)

3. Prior endoscopic therapy for Barrett's lesions, such as photodynamic therapy or
endoscopic mucosal resection (EMR)

4. Presence of esophagitis > Los Angeles grade A classification

5. Presence of conditions precluding histological sampling of the esophagus (e.g.,
esophageal varices, coagulation disorders, anticoagulant therapy)

6. Pregnancy

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

1. The number of patients and the number of lesions with HGD or early ACA detected with WLE and ETMI 2. The number of patients with HGD and early ACA detected with targeted biopsies only with ETMI and WLE

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Louis M WongKeeSong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

07-003997

NCT ID:

NCT00586989

Start Date:

December 2007

Completion Date:

September 2010

Related Keywords:

  • Barretts Esophagus
  • High Grade Dysplasia
  • Early Esophageal Adenocarcinoma
  • Barrett's Esophagus
  • Esophageal Cancer
  • High Grade Dysplasia
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Barrett Esophagus
  • Esophageal Diseases

Name

Location

Mayo ClinicJacksonville, Florida  32224