Clinical trial NCT01124214: Confocal Endomicroscopy for Improved Diagnosis of Barrett's Esophagus and Early Esophageal Cancer(CEBE Study)
Official title: In Vivo Endomicroscopy (EM) for Improved Diagnosis of Barrett's Esophagus (BE) and Associated Neoplasia: A Multicenter Randomized Controlled Trial of Diagnostic Yield and Clinical Impact
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett's Esophagus, Esophageal Intraepithelial Neoplasia
Keywords: Barrett's
BE
esophageal cancer
esophageal dysplasia
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: American Society for Gastrointestinal Endoscopy
name: Pentax Medical Corporation
First posted: 2010-05-17
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: The central hypothesis is that endomicroscopy (EM) can improve the efficiency of the endoscopic diagnosis of Barrett's esophagus (BE) and associated Intraepithelial neoplasia(IEN), providing in-vivo optical biopsies comparable to standard histology. Specifically, EM will enable targeted biopsy rather than random mucosal biopsy during routine endoscopic surveillance of BE or endoscopic evaluation of patients with suspected or proven unlocalized IEN, 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.

The investigators also hypothesize that EM will provide additional accurate information regarding the presence of IEN that will impact upon the physician's decision to obtain a mucosal 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 to another procedure after the pathology from the mucosal biopsies are available. This study is important because it will validate single center studies supporting the routine use of EM for screening and surveillance of BE.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: compare diagnostic yield
timeFrame: 1 year
Secondary outcomes:
measure: assess clinical impact of EM
timeFrame: 1 year
measure: compare the specificity and sensitivity of HRE with EM
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Institution
state: Pennsylvania
city: Mainz
country: Germany
facility: Johannes Gutenberg - University of Mainz
Study officials:
affiliation: Johns Hopkins University
name: Marcia I Canto, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Canto MI, Anandasabapathy S, Brugge W, Falk GW, Dunbar KB, Zhang Z, Woods K, Almario JA, Schell U, Goldblum J, Maitra A, Montgomery E, Kiesslich R; Confocal Endomicroscopy for Barrett's Esophagus or Confocal Endomicroscopy for Barrett's Esophagus (CEBE) Trial Group. In vivo endomicroscopy improves detection of Barrett's esophagus-related neoplasia: a multicenter international randomized controlled trial (with video). Gastrointest Endosc. 2014 Feb;79(2):211-21. doi: 10.1016/j.gie.2013.09.020. Epub 2013 Nov 9.