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In Vivo Endomicroscopy (EM) for Improved Diagnosis of Barrett's Esophagus (BE) and Associated Neoplasia: A Multicenter Randomized Controlled Trial of Diagnostic Yield and Clinical Impact


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Barrett's Esophagus, Esophageal Intraepithelial Neoplasia

Thank you

Trial Information

In Vivo Endomicroscopy (EM) for Improved Diagnosis of Barrett's Esophagus (BE) and Associated Neoplasia: A Multicenter Randomized Controlled Trial of Diagnostic Yield and Clinical Impact


The central hypothesis is that endomicroscopy (EM) can improve the efficiency of the
endoscopic diagnosis of Barrett's esophagus (BE) and associated Intraepithelial
neoplasia(IEN), providing in-vivo optical biopsies comparable to standard histology.
Specifically, EM will enable targeted biopsy rather than random mucosal biopsy during
routine endoscopic surveillance of BE or endoscopic evaluation of patients with suspected or
proven unlocalized IEN, which will improve the diagnostic yield of mucosal samples for BE
IEN. Furthermore, when combined with high resolution endoscopy, EM may improve the overall
in vivo detection of IEN in lesions as well as flat mucosa.

The investigators also hypothesize that EM will provide additional accurate information
regarding the presence of IEN that will impact upon the physician's decision to obtain a
mucosal biopsy or perform endoscopic mucosal resection (EMR). This could potentially
minimize the number of unnecessary biopsies and as well as enable the physician to perform
EMR at the time of the initial examination, rather than delaying endoscopic treatment to
another procedure after the pathology from the mucosal biopsies are available. This study is
important because it will validate single center studies supporting the routine use of EM
for screening and surveillance of BE.


Inclusion Criteria:



- Surveillance of Barrett's esophagus or suspected or known BE associated neoplasia

Exclusion Criteria:

- Allergy or prior reaction to the fluorescent contrast agent fluorescein sodium

- Unable to give informed consent.

- Pregnant or breastfeeding women

- Known advanced adenocarcinoma in the esophagus

- Dysplastic or suspected malignant esophageal lesion 0 BE lesions 2 cm or more in size
with Paris classification of 0-Ip (polypoid), 0-Is (protruding sessile), 0-IIa (flat
elevated), or 0-IIb (flat)

- Lesions of any size with Paris 0-IIc (superficial shallow depressed) or 0-III
(excavated)

- Acute gastrointestinal bleeding

- Coagulopathy defined by PTT > 50 sec, or INR > 2.0, platelets < 40,000, or on chronic
anticoagulation

- Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or
other contraindication to endoscopy.

- History of a severe allergic reaction (anaphylaxis)

- Known, untreated esophageal strictures, prior partial esophageal resection, or
altered anatomy preventing passage of the endomicroscope

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

compare diagnostic yield

Outcome Description:

Compare the diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRE plus EM with directed biopsy (HRE-EM-DB) over HRE with directed biopsy of all mucosal lesions followed by random biopsy (HRE-DB-RB) to diagnose BE in flat mucosa and mucosal lesions The mean diagnostic yield for IEN will be calculated (number of mucosal biopsies and EMR specimens with HGD or CA divided by total number of mucosal biopsies obtained) by group and compared, using a chi square or Fisher's exact test for independent groups, depending on the distribution of the data.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Marcia I Canto, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins Medicine

Authority:

United States: Institutional Review Board

Study ID:

NA_00025471

NCT ID:

NCT01124214

Start Date:

April 2010

Completion Date:

June 2013

Related Keywords:

  • Barrett's Esophagus, Esophageal Intraepithelial Neoplasia
  • Barrett's
  • BE
  • esophageal cancer
  • esophageal dysplasia
  • Barrett Esophagus
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Carcinoma in Situ

Name

Location
Mount Sinai School of Medicine New York, New York  10029
Massachusetts General Hospital Boston, Massachusetts  02114-2617
University of Pennsylvania Medical Institution Philadelphia, Pennsylvania  19104