Confocal Endomicroscopy for Improved Diagnosis of Barrett's Esophagus and Early Esophageal Cancer(CEBE Study)
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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 |
- 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.
- 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: | April 2010 |
| Estimated 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 |
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| Contact: Hilary Cosby, RN, CGRN | 410-502-2893 | hcosby1@jhmi.edu |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02199 | |
| Contact: Ozden Narin, MD 617-724-0462 onarin@partners.org | |
| Principal Investigator: William Brugge, MD | |
| United States, New York | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Josephine Mitcham 212-241-6293 Josephine.mitcham@mountsinai.org | |
| Principal Investigator: Sharmilla Anandasabathy, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania Medical Institution | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Terri Kerbowski 267-426-7765 kerbowskit@email.chop.edu | |
| Principal Investigator: Gary Falk, MD | |
| Germany | |
| Johannes Gutenberg - University of Mainz | Recruiting |
| Mainz, Germany | |
| Contact: Ursula Schell ursula-schell@web.de | |
| Principal Investigator: Ralf Kiesslich, MD | |
| Principal Investigator: | Marcia I Canto, MD | Johns Hopkins Medicine |
More Information
Additional Information:
No publications provided
| 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: | February 14, 2013 |
| 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 Diseases Esophageal Neoplasms Carcinoma in Situ Digestive System Abnormalities Digestive System 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 May 16, 2013