Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma

Last updated: January 12, 2021
Sponsor: Anandasabapathy, Sharmila, M.D.
Overall Status: Active - Recruiting

Phase

2

Condition

Barrett's Esophagus

Heartburn

Adenocarcinoma

Treatment

N/A

Clinical Study ID

NCT02018367
GCO #12-0289, H-36538
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • outpatients with > 1 cm biopsy-proven Barrett's Esophagus who are undergoing standardof care endoscopic surveillance for metaplasia, dysplasia, or neoplasia.

Exclusion

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/suspectedmalignant 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 orother
  • Patients with known, untreated esophageal strictures, prior partial esophagealresection, or altered anatomy preventing passage of the endomicroscope
  • Patients with known severe esophagitis
  • Patients with suspected but no biopsy confirmed BE

Study Design

Total Participants: 100
Study Start date:
September 01, 2012
Estimated Completion Date:
December 31, 2021

Study 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)

Connect with a study center

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

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