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

NCT00586989 | Completed

• 1 other identifier: 07-003997
• Study Type: observational
• Target: 60
• Locations: 2 countries
• Sites: 2

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.

Conditions

Barretts Esophagus; High Grade Dysplasia; Early Esophageal Adenocarcinoma

Keywords

Barrett's Esophagus; Esophageal Cancer; High Grade Dysplasia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (1)

1

Patient with Barrett's Esophagus with a history of High grade dysplasia or early esophageal adenocarcinoma

Procedure: Upper endoscopy with biopsy

Interventions

Upper endoscopy with biopsy PROCEDURE

Endoscopy with biopsy 6 weeks after the initial endoscopy

Also known as: ETMI system (Olympus, Tokyo, Japan)

1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

esophageal biopsies

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus; Esophageal Neoplasms

Interventions

Gastroscopy; Biopsy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Investigative Techniques

Study Officials

• Louis M WongKeeSong, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: December 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 7, 2016

Record last verified: 2010-09

Locations

US (1); NL (1)