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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00586989
First received: December 21, 2007
Last updated: September 28, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Barretts Esophagus
High Grade Dysplasia
Early Esophageal Adenocarcinoma
Procedure: Upper endoscopy with biopsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

esophageal biopsies


Enrollment: 60
Study Start Date: December 2007
Study Completion Date: September 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patient with Barrett's Esophagus with a history of High grade dysplasia or early esophageal adenocarcinoma
Procedure: Upper endoscopy with biopsy
Endoscopy with biopsy 6 weeks after the initial endoscopy
Other Name: ETMI system (Olympus, Tokyo, Japan)

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

patients with barrett's esophagus or esophageal cancer referred for endoscopy

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586989

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Netherlands
Academic Medical Center
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Louis M WongKeeSong, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Louis Michel WongKeeSong, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00586989     History of Changes
Other Study ID Numbers: 07-003997, 07-003997
Study First Received: December 21, 2007
Last Updated: September 28, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Barrett's Esophagus
Esophageal Cancer
High Grade Dysplasia

Additional relevant MeSH terms:
Adenocarcinoma
Barrett Esophagus
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on April 15, 2014