Confocal Endomicroscopy for Barrett's Esophagus

Study Overview
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Brief Summary
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The purpose of this study is to determine if confocal laser endomicroscopy (CLE) can improve detection of Barrett's esophagus, dysplasia, and early esophageal cancer.

Detailed Description
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Barrett's esophagus is a leading cause of esophageal adenocarcinoma. Detection of dysplasia and early cancers in Barrett's esophagus can be challenging, time-consuming and expensive. Small lesions may be difficult to detect with standard endoscopy protocols. Confocal laser endomicroscopy (CLE) is a new type of endoscopy where a small confocal microscope is built into the tip of a standard endoscope. For this study, we are comparing confocal laser endomicroscopy (CLE) with targeted biopsies with standard endoscopy (EGD)and biopsy for Barrett's esophagus to determine if CLE is more effective for detecting dysplasia and cancer. Participants with Barrett's esophagus in this study undergo 1) CLE with targeted mucosal biopsies (biopsy only taken if CLE shows abnormal tissue) and 2) standard EGD with biopsies. The order of procedures is randomized (some patients have CLE first while others have standard EGD first).

Official Title
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Confocal Laser Endomicroscopy for Improved Diagnosis of Barrett's Esophagus and Associated Neoplasia

Conditions
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Barrett's Esophagus, Esophageal Adenocarcinoma

Intervention / Treatment
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* Device: confocal laser endomicroscopy (CLE)
* Device: standard endoscopy (EGD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Barrett's esophagus or suspected Barrett's-associated neoplasia Age > 18 Able to give informed consent Exclusion Criteria: Known advanced malignant disease Allergy to the fluorescent contrast agent fluorescein sodium Coagulopathy or bleeding disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CLE followed by standard EGD<br>Participants are randomized to have either confocal laser endomicroscopy (CLE) or standard endoscopy (EGD) first. Then 6 weeks later, they have the other procedure. This arm is for patients randomized to CLE followed by standard EGD | Device: confocal laser endomicroscopy (CLE)<br>* Confocal laser endomicroscopy is done by performing standard endoscopy, then using a microscope on the tip of the endoscope to obtain microscopic images of the mucosa. This is done by gently placing the tip of the endoscope on the lining of the esophagus.<br>* Other names: Pentax Confocal Laser Endomicroscope(EC3870KCILK);Device: standard endoscopy (EGD)<br>* Standard upper endoscopy (EGD) is performed using a regular upper endoscope, which is used to look at the lining of the esophagus.<br>* Other names: Olympus upper endoscope (GIF160);|
| Active Comparator: standard EGD followed by CLE<br>Patients are randomized to either have standard endoscopy (EGD)or confocal laser endomicroscopy (CLE) first. The second procedure is then completed 6 weeks later. This arm is for patients who had standard endoscopy first. | Device: confocal laser endomicroscopy (CLE)<br>* Confocal laser endomicroscopy is done by performing standard endoscopy, then using a microscope on the tip of the endoscope to obtain microscopic images of the mucosa. This is done by gently placing the tip of the endoscope on the lining of the esophagus.<br>* Other names: Pentax Confocal Laser Endomicroscope(EC3870KCILK);Device: standard endoscopy (EGD)<br>* Standard upper endoscopy (EGD) is performed using a regular upper endoscope, which is used to look at the lining of the esophagus.<br>* Other names: Olympus upper endoscope (GIF160);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia) | The yield for neoplasia is calculated by the number of biopsies showing neoplasia over the total number of biopsies taken (normal + neoplastic biopsies) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Biopsies With Neoplasia in High Risk Patients (Suspected Neoplasia) | The number of biopsies from each procedure (i.e. biopsies taken during CLE, or biopsies taken during standard EGD) that showed neoplasia. Neoplasia is high grade dysplasia or cancer. This analysis looks at patients with Barrett's suspected (but not known) neoplasia. | 6 weeks | 
| Mean Number of Biopsies Taken in High Risk Patients (Suspected Neoplasia) | The number of biopsies taken during each procedure (i.e. the number of biopsies taken during CLE, or the number of biopsies taken during standard EGD). Biopsies are taken during CLE only if CLE shows that the esophageal mucosa is abnormal. Esophageal biopsies are taken during standard EGD using a standard Barrett's esophagus protocol (4 quadrants, every 1-2 cm of the Barrett's esophagus). This analysis looks at the Barrett's patients with suspected (but not known) neoplasia. | 6 weeks | 
| Diagnostic Yield for Neoplasia in Barrett's Surveillance Patients | Our hypothesis was that the yield for neoplasia would be higher using confocal laser endomicroscopy compared to standard endoscopy. The null hypothesis would be that there is no difference in yield for neoplasia when CLE is used compared to standard endoscopy. This analysis looks specifically at patients who were referred for surveillance of Barrett's esophagus (no suspected neoplasia). | 6 weeks | 
| Mean Number of Biopsies With Neoplasia in Barrett's Surveillance Patients | The number of biopsies from each procedure (i.e. biopsies taken during CLE, or biopsies taken during standard EGD) that showed neoplasia. Neoplasia is high grade dysplasia or cancer. This analysis looks at patients undergoing surveillance EGD for Barrett's esophagus (no suspected neoplasia). | 6 weeks | 
| Mean Number of Biopsies Taken in Barrett's Surveillance Patients | The number of biopsies taken during each procedure (i.e. the number of biopsies taken during CLE, or the number of biopsies taken during standard EGD). Biopsies are taken during CLE only if CLE shows that the esophageal mucosa is abnormal. Esophageal biopsies are taken during standard EGD using a standard Barrett's esophagus protocol (4 quadrants, every 1-2 cm of the Barrett's esophagus). This analysis looks at the patients with Barrett's esophagus in the study who were undergoing surveillance EGD (no suspected neoplasia). | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barrett's esophagus, Esophageal adenocarcinoma, Endoscopy, Confocal laser endomicroscopy