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

Anandasabapathy, Sharmila, M.D.

Status and phase: Unknown; Phase 2

Conditions: Barrett's Esophagus

Treatments: Drug: Proflavine, high resolution imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02018367

GCO #12-0289, H-36538

Details and patient eligibility

About

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)

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Proflavine, high resolution imaging

Experimental group

Description:

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.

Treatment:

Drug: Proflavine, high resolution imaging

Standard of care

No Intervention group

Description:

Standard of care examination of the upper GI tract using the standard high resolution endoscope with bipsies taken per Seattle biopsy protocol for Barrett's Esophagus surveillance.