Confocal Endomicroscopy for Barrett's Esophagus

NCT ID: NCT00487695

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2008-09-30

Brief Summary

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

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).

Conditions

Barrett's Esophagus; Esophageal Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CLE followed by standard EGD

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

Group Type: ACTIVE_COMPARATOR

confocal laser endomicroscopy (CLE)

Intervention Type: 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.

standard endoscopy (EGD)

Intervention Type: DEVICE

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

standard EGD followed by CLE

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.

Group Type: ACTIVE_COMPARATOR

confocal laser endomicroscopy (CLE)

Intervention Type: 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.

standard endoscopy (EGD)

Intervention Type: DEVICE

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

Interventions

confocal laser endomicroscopy (CLE)

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.

Intervention Type: DEVICE

standard endoscopy (EGD)

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

Intervention Type: DEVICE

Other Intervention Names

Pentax Confocal Laser Endomicroscope(EC3870KCILK); Olympus upper endoscope (GIF160)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society for Gastrointestinal Endoscopy

OTHER

Sponsor Role: collaborator

Pentax, USA

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcia I Canto, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Division of Gastroenterology, Johns Hopkins University School of Medicine

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

Dunbar KB, Okolo P 3rd, Montgomery E, Canto MI. Confocal laser endomicroscopy in Barrett's esophagus and endoscopically inapparent Barrett's neoplasia: a prospective, randomized, double-blind, controlled, crossover trial. Gastrointest Endosc. 2009 Oct;70(4):645-54. doi: 10.1016/j.gie.2009.02.009. Epub 2009 Jun 25.

Reference Type: RESULT

PMID: 19559419 (View on PubMed)

Other Identifiers

NA0002805

Identifier Type: -

Identifier Source: org_study_id