Endoscopic Tri-Modal Imaging in Patients With Barrett's Esophagus

Barretts Esophagus Clinical Trial

— ETMI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586989
• Other study ID #: 07-003997
• Secondary ID: 07-003997
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: January 5, 2016
• Start date: December 2007
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Esophagus
• Barretts Esophagus
• Early Esophageal Adenocarcinoma
• Esophageal Neoplasms
• High Grade Dysplasia

Intervention

Procedure:
• Upper endoscopy with biopsy
Endoscopy with biopsy 6 weeks after the initial endoscopy

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2 years	No
Secondary	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)		2 years	No