Accuracy, Yield and Clinical Impact of a Low-Cost High Resolution Microendoscope in the Early Diagnosis of Esophageal Adenocarcinoma
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Proflavine, high resolution imaging
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.
Intervention: Proflavine, high resolution imaging (Drug)
Outcomes
Primary Outcomes
The diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy
Time Frame: 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 Outcomes
- The diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of HRME for the in-vivo diagnosis of neoplasia.(1 day)