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

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.

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Key information

Conditions

Barretts Esophagus Adenocarcinoma Of Esophagus Barrett Esophagus Digestive System Diseases Digestive System Neoplasms Early Esophageal Adenocarcinoma Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms High Grade Dysplasia Neoplasms Neoplasms by Site Precancerous Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Academic Medical Center, Amsterdam, Netherlands

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age > 18 years
Prior diagnosis of BE, defined as the presence of columnar-lined epithelium in the distal tubular esophagus with specialised intestinal metaplasia on histological investigation
Prior diagnosis of HGD or early ACA that was endoscopically inconspicuous according to the referring source
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
Ability to provide written informed consent

Exclusion criteria

Description of a visibly suspicious lesion within the Barrett's segment according to the referring source
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)
Prior endoscopic therapy for Barrett's lesions, such as photodynamic therapy or endoscopic mucosal resection (EMR)
Presence of esophagitis > Los Angeles grade A classification
Presence of conditions precluding histological sampling of the esophagus (e.g., esophageal varices, coagulation disorders, anticoagulant therapy)
Pregnancy

Treatment and study plan

Upper endoscopy with biopsy

Procedure

Endoscopy with biopsy 6 weeks after the initial endoscopy

Other names: ETMI system (Olympus, Tokyo, Japan)

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Acronym: ETMI

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Jan 7, 2008
Registry last updated: Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed