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| Name | Class |
|---|---|
| American Society for Gastrointestinal Endoscopy | OTHER |
| Pentax Medical Corporation | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endomicroscopy | Procedure | endomicroscopy scope lens has capability to optically evaluate mucosa/submucosa as a microscope |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| assess clinical impact of EM | 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. | 1 year |
| compare the specificity and sensitivity of HRE with EM |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcia I Canto, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02199 | United States | ||
| Mount Sinai School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24219822 | Background | 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. |
| Label | URL |
|---|---|
| Johns Hopkins GI website, Barrett's esophagus section | View source |
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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. |
| 1 year |
| New York |
| New York |
| 10029 |
| United States |
| University of Pennsylvania Medical Institution | Philadelphia | Pennsylvania | 19104 | United States |
| Johannes Gutenberg - University of Mainz | Mainz | Germany |
| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D020717 | Eukaryotic Initiation Factor-2B |
| D018613 | Microscopy, Confocal |
| ID | Term |
|---|---|
| D020662 | Guanine Nucleotide Exchange Factors |
| D020555 | GTP-Binding Protein Regulators |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D039642 | Eukaryotic Initiation Factors |
| D010448 | Peptide Initiation Factors |
| D012269 | Ribosomal Proteins |
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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