Barrett's Esophagus
Conditions
Keywords
Barrett's esophagus, proflavine, Microscopic imaging
Brief summary
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).
Detailed description
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 * 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? Secondary outcomes: * sensitivity, specificity, positive predictive value, and negative predictive value of HRME for the in-vivo diagnosis of neoplasia in a routine surveillance population of patients with BE (using histopathologic diagnosis of mucosal biopsies as the reference standard) * the total procedure time for imaging and mucosal biopsy acquisition of HRME - compared with WL, stratified by length of BE (\< 3 cm and \> 3cm)
Interventions
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.
Sponsors
William Marsh Rice University
Baylor College of Medicine
Anandasabapathy, Sharmila, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* outpatients with \> 1 cm biopsy-proven Barrett's Esophagus who are undergoing standard of care endoscopic surveillance for metaplasia, dysplasia, or neoplasia.
Exclusion criteria
* Allergy or prior reaction to the fluorescent contrast agent proflavine * Patients who are unable to give informed consent. * Known advanced adenocarcinoma of the distal esophagus, or dysplastic/suspected malignant esophageal lesion \> 2 cm in size not amenable to EMR * Patients with a history of a severe allergic reaction (anaphylaxis) * Patients unable to undergo routine endoscopy with biopsy : * Women who are pregnant or breastfeeding * Prothrombin Time \> 50% of control; PTT \> 50 sec, or INR \> 2.0) * Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other * Patients with known, untreated esophageal strictures, prior partial esophageal resection, or altered anatomy preventing passage of the endomicroscope * Patients with known severe esophagitis * Patients with suspected but no biopsy confirmed BE
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy | 1 day | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of HRME for the in-vivo diagnosis of neoplasia. | 1 day | To be determined using histopathologic diagnosis of mucosal biopsise as the reference standard |
Other
| Measure | Time frame | Description |
|---|---|---|
| The clinical impact of HRME on the diagnosis and endoscopic surveillance of BE- associated neoplasia | 1 day | 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? |
Countries
United States
Outcome results
None listed