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| Name | Class |
|---|---|
| William Marsh Rice University | OTHER |
| Baylor College of Medicine | OTHER |
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The overall goal of the study is to determine whether imaging with the low-cost High Resolution Microendoscope(HRME) will increase the efficiency and yield of the current standard of endoscopic surveillance of Barrett's esophagus. We believe the HRME will provide an in-vivo "optical biopsy" that will be comparable to gold standard histopathology and allow the endoscopist to make a more informed decision about whether to obtain a biopsy or even perform endoscopic therapy (i.e. endoscopic mucosal resection, EMR).
Primary outcomes:
the diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy
- compared to standard white-light endoscopy with 4-quadrant random biopsy (WL) for the diagnosis of BE-associated neoplasia in flat mucosa as well as mucosal lesions
the clinical impact of HRME on the diagnosis and endoscopic surveillance of BE- associated neoplasia
Secondary outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proflavine, high resolution imaging | Experimental | Proflavine hemisulfate will be used as a topical contrast agent in conjunction with the high resolution imaging device to visualize and image areas suspicious for neoplasia. Biopsies will be taken per Seattle biopsy protocol for Barrett's Esophagus surveillance. |
|
| Standard of care | No Intervention | Standard of care examination of the upper GI tract using the standard high resolution endoscope with bipsies taken per Seattle biopsy protocol for Barrett's Esophagus surveillance. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proflavine, high resolution imaging | Drug | 5-10mL of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the biopsy channel of the endoscope and gently placed against the mucosa. The endoscopist will image each discrete lesion observed during white light endoscopy. For each HRME imaged area, an optical read will be obtained followed by a tissue biopsy. |
| Measure | Description | Time Frame |
|---|---|---|
| The diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy | Compared to standard white-light endoscopy with 4-quadrant random biopsy (WL) for the diagnosis of BE-associated neoplasia in flat mucosa as well as mucosal lesions | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| The diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of HRME for the in-vivo diagnosis of neoplasia. | To be determined using histopathologic diagnosis of mucosal biopsise as the reference standard | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| The clinical impact of HRME on the diagnosis and endoscopic surveillance of BE- associated neoplasia | Does HRME alter the decision to obtain a mucosal biopsy or perform endoscopic mucosal resection (EMR) The total number of total mucosal biopsies taken per procedure; does HRME alter the number of biopsies necessary? | 1 day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharmila Anandasabapathy, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26253018 | Derived | Shin D, Lee MH, Polydorides AD, Pierce MC, Vila PM, Parikh ND, Rosen DG, Anandasabapathy S, Richards-Kortum RR. Quantitative analysis of high-resolution microendoscopic images for diagnosis of neoplasia in patients with Barrett's esophagus. Gastrointest Endosc. 2016 Jan;83(1):107-14. doi: 10.1016/j.gie.2015.06.045. Epub 2015 Aug 5. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 14, 2017 | Jun 25, 2018 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 14, 2017 | Jun 28, 2018 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2017 | Jun 28, 2018 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D011370 | Proflavine |
| ID | Term |
|---|---|
| D000609 | Aminoacridines |
| D000166 | Acridines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
|
| D004066 |
| Digestive System Diseases |
| D006571 | Heterocyclic Compounds |