Esophageal Cancer Clinical Trial
Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma
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).
Full 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)
Eligibility Criteria
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
How clear is this clinincal trial information?