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

NCT01124214 | Completed DMC

• 1 other identifier: NA_00025471
• Study Type: interventional
• Target: 68
• Locations: 2 countries
• Sites: 4

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.

Conditions

Barrett's Esophagus, Esophageal Intraepithelial Neoplasia

Keywords

Barrett's; BE; esophageal cancer; esophageal dysplasia

Outcome Measures

Primary Outcomes (1)

• compare diagnostic yield

  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 High Grade Dysplasia (HGD) or Carcinoma (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.

  1 year

Secondary Outcomes (2)

• assess clinical impact of EM

  1 year

• compare the specificity and sensitivity of HRE with EM

  1 year

Study Arms (2)

High Resolution endoscopy (HRE)

NO INTERVENTION

Standard of care, high resolution endoscopy surveillance/ evaluation of BE and or IEN

Endomicroscopy (EM)

ACTIVE COMPARATOR

Standard of care, high resolution endoscopy surveillance/ evaluation of BE and or IEN and endomicroscopy esophageal evaluation

Procedure: endomicroscopy

Interventions

endomicroscopy PROCEDURE

endomicroscopy scope lens has capability to optically evaluate mucosa/submucosa as a microscope

Also known as: Confocal Laser Microscopy (CLE), EM, confocal microscopy

Endomicroscopy (EM)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• American Society for Gastrointestinal Endoscopy: collaborator
• Pentax Medical Corporation: collaborator

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02199, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

University of Pennsylvania Medical Institution

Philadelphia, Pennsylvania, 19104, United States

Location

Johannes Gutenberg - University of Mainz

Mainz, Germany

Location

Related Publications (1)

• 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.

  PMID: 24219822 BACKGROUND

Related Links

• Johns Hopkins GI website, Barrett's esophagus section

MeSH Terms

Conditions

Barrett Esophagus; Esophageal Neoplasms

Interventions

Eukaryotic Initiation Factor-2B; Microscopy, Confocal

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)

Guanine Nucleotide Exchange Factors; GTP-Binding Protein Regulators; Intracellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Eukaryotic Initiation Factors; Peptide Initiation Factors; Ribosomal Proteins; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Marcia I Canto, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2010
• First Posted: May 17, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

DE (1); US (3)