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

This study has been completed.
Sponsor:
Collaborators:
American Society for Gastrointestinal Endoscopy
Pentax Medical Corporation
Information provided by (Responsible Party):
MCanto, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01124214
First received: May 13, 2010
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

Endomicroscopy (EM) can improve the diagnosis Barrett's esophagus (BE) and some early esophageal cancers (Intraepithelial 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.


Condition Intervention Phase
Barrett's Esophagus, Esophageal Intraepithelial Neoplasia
Procedure: endomicroscopy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • compare diagnostic yield [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Compare the diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRE plus EM with directed biopsy (HRE-EM-DB) over HRE with directed biopsy of all mucosal lesions followed by random biopsy (HRE-DB-RB) to diagnose BE in flat mucosa and mucosal lesions

    The mean diagnostic yield for IEN will be calculated (number of mucosal biopsies and EMR specimens with HGD or CA divided by total number of mucosal biopsies obtained) by group and compared, using a chi square or Fisher's exact test for independent groups, depending on the distribution of the data.



Secondary Outcome Measures:
  • assess clinical impact of EM [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To prospectively assess the potential clinical impact of EM on the diagnosis and endoscopic surveillance of BE by determining if EM alters the decision to biopsy or EMR and change the total of biopsies per procedure.

  • compare the specificity and sensitivity of HRE with EM [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To compare the performance (sensitivity and specificity) characteristics of HRE-EM-DB with HRE-RB for prediction of BE/IEN using the pathologic diagnosis of mucosal biopsies the as the reference standard.


Estimated Enrollment: 200
Study Start Date: July 2010
Study Completion Date: June 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: High Resolution endoscopy (HRE)
Standard of care, high resolution endoscopy surveillance/ evaluation of BE and or IEN
Active Comparator: Endomicroscopy (EM)
Standard of care, high resolution endoscopy surveillance/ evaluation of BE and or IEN and endomicroscopy esophageal evaluation
Procedure: endomicroscopy
endomicroscopy scope lens has capability to optically evaluate mucosa/submucosa as a microscope
Other Name: CLE, EM, confocal microscopy

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 PTT > 50 sec, or 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124214

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02199
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, Pennsylvania
University of Pennsylvania Medical Institution
Philadelphia, Pennsylvania, United States, 19104
Germany
Johannes Gutenberg - University of Mainz
Mainz, Germany
Sponsors and Collaborators
Johns Hopkins University
American Society for Gastrointestinal Endoscopy
Pentax Medical Corporation
Investigators
Principal Investigator: Marcia I Canto, MD Johns Hopkins Medicine
  More Information

Additional Information:
No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MCanto, Professor of Medicine and Oncology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01124214     History of Changes
Other Study ID Numbers: NA_00025471
Study First Received: May 13, 2010
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Barrett's
BE
esophageal cancer
esophageal dysplasia

Additional relevant MeSH terms:
Barrett Esophagus
Neoplasms
Esophageal Neoplasms
Carcinoma in Situ
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 26, 2014