Clinical trial NCT02018367: Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma
Official title: Accuracy, Yield and Clinical Impact of a Low-Cost High Resolution Microendoscope in the Early Diagnosis of Esophageal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Barrett's Esophagus
Keywords: Barrett's esophagus
proflavine
Microscopic imaging
Lead sponsor: Anandasabapathy, Sharmila, M.D.
Sponsor class: INDIV
Collaborators: name: William Marsh Rice University
name: Baylor College of Medicine
First posted: 2013-12-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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)

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

Primary outcomes:
measure: The diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy
timeFrame: 1 day
Secondary outcomes:
measure: The diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of HRME for the in-vivo diagnosis of neoplasia.
timeFrame: 1 day
Other outcomes:
measure: The clinical impact of HRME on the diagnosis and endoscopic surveillance of BE- associated neoplasia
timeFrame: 1 day
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Sharmila Anandasabapathy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.