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Completed

NCT Number: NCT00487695

Confocal Endomicroscopy for Barrett's Esophagus

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.

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Key information

Conditions

Barrett's Esophagus Adenocarcinoma Of Esophagus Barrett Esophagus Digestive System Diseases Esophageal Adenocarcinoma Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Confocal Laser Endomicroscopy (CLE)

Device

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.

Other names: Pentax Confocal Laser Endomicroscope(EC3870KCILK)

standard endoscopy (EGD)

Device

Standard upper endoscopy (EGD) is performed using a regular upper endoscope, which is used to look at the lining of the esophagus.

Other names: Olympus upper endoscope (GIF160)

Primary outcomes

  1. Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia)

    Time frame: 6 weeks

    The yield for neoplasia is calculated by the number of biopsies showing neoplasia over the total number of biopsies taken (normal + neoplastic biopsies)

Secondary outcomes

  1. Mean Number of Biopsies With Neoplasia in High Risk Patients (Suspected Neoplasia)

    Time frame: 6 weeks

    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.

  2. Mean Number of Biopsies Taken in High Risk Patients (Suspected Neoplasia)

    Time frame: 6 weeks

    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.

  3. Diagnostic Yield for Neoplasia in Barrett's Surveillance Patients

    Time frame: 6 weeks

    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).

  4. Mean Number of Biopsies With Neoplasia in Barrett's Surveillance Patients

    Time frame: 6 weeks

    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).

  5. Mean Number of Biopsies Taken in Barrett's Surveillance Patients

    Time frame: 6 weeks

    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).

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • American Society for Gastrointestinal Endoscopy
  • Pentax, USA

Registry information

Official study title

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

Acronym: CEBE

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 19, 2007
Registry last updated
Jun 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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