Clinical trial NCT00586989: Endoscopic Tri-Modal Imaging in Patients With Barrett's Esophagus
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barretts Esophagus
High Grade Dysplasia
Early Esophageal Adenocarcinoma
Keywords: Barrett's Esophagus
Esophageal Cancer
High Grade Dysplasia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with barrett's esophagus or esophageal cancer referred for endoscopy

Brief summary: This study is being done to determine if a new endoscope will help doctors identify pre-cancer or early cancer lesions in patients who have Barrett's esophagus. This new endoscope allows the doctor to look at the lining of the esophagus in 3 different ways by modifying light.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 2 years
Secondary outcomes:
measure: 1. The positive predictive value (PPV) of HRE and AFI 2. The reduction of false-positive findings after NBI (both the initial in vivo NBI assessment as well as later assessment based on still images)
timeFrame: 2 years
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
affiliation: Mayo Clinic
name: Louis M WongKeeSong, MD
role: PRINCIPAL_INVESTIGATOR
References: