Confocal Endomicroscopy for Improved Diagnosis of Barrett's Esophagus and Early Esophageal Cancer(CEBE Study)

Completed · Not applicable

Conditions studied: Barrett's Esophagus, Esophageal Intraepithelial Neoplasia

In brief

Endomicroscopy (EM) can improve the diagnosis Barrett's esophagus (BE) and some early esophageal cancers (Intra Epithelial Neoplasia (IEN)). EM provides optical biopsies comparable to standard histology. Specifically, EM allows targeted biopsy rather than random mucosal biopsy during routine endoscopic surveillance of BE or evaluation EIN, which will improve the diagnostic yield of mucosal samples for BE IEN. Furthermore, when combined with high resolution endoscopy, EM may improve the overall in vivo detection of IEN in lesions as well as flat mucosa. EM will provide accurate place and size of IEN which will impact the physician's decision to biopsy or perform endoscopic mucosal resection (EMR). This could potentially minimize the number of unnecessary biopsies and as well as enable the physician to perform EMR at the time of the initial examination, rather than delaying endoscopic treatment after the pathology is available. This study is important because it will validate single center studies supporting the routine use of EM for screening and surveillance of BE.

Key facts

Study ID

NCT01124214

Run by

Johns Hopkins University

People needed

68

Starts

2010-07-01

Expected to finish

2013-06-01

Last updated by the study team

2023-05-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Surveillance of Barrett's esophagus or suspected or known BE associated neoplasia

You may not qualify if…

• Allergy or prior reaction to the fluorescent contrast agent fluorescein sodium
• Unable to give informed consent.
• Pregnant or breastfeeding women
• Known advanced adenocarcinoma in the esophagus
• Dysplastic or suspected malignant esophageal lesion 0 BE lesions 2 cm or more in size with Paris classification of 0-Ip (polypoid), 0-Is (protruding sessile), 0-IIa (flat elevated), or 0-IIb (flat)
• Lesions of any size with Paris 0-IIc (superficial shallow depressed) or 0-III (excavated)
• Acute gastrointestinal bleeding
• Coagulopathy defined by Partial Thromboplastin Time (PTT) > 50 sec, or International Normalized Ratio (INR) > 2.0, platelets < 40,000, or on chronic anticoagulation
• Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy.
• History of a severe allergic reaction (anaphylaxis)
• Known, untreated esophageal strictures, prior partial esophageal resection, or altered anatomy preventing passage of the endomicroscope

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mount Sinai School of Medicine — New York, New York, United States
• University of Pennsylvania Medical Institution — Philadelphia, Pennsylvania, United States
• Johannes Gutenberg - University of Mainz — Mainz, Germany

Full record on ClinicalTrials.gov

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