Confocal Endomicroscopy for Barrett's Esophagus

NCT00487695 | Completed Phase 3 Results DMC

• 1 other identifier: NA0002805
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Barrett's Esophagus; Esophageal Adenocarcinoma

Keywords

Barrett's esophagus; Esophageal adenocarcinoma; Endoscopy; Confocal laser endomicroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  6 weeks

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

  6 weeks

• Diagnostic Yield for Neoplasia in Barrett's Surveillance Patients

  6 weeks

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

  6 weeks

• Mean Number of Biopsies Taken in Barrett's Surveillance Patients

  6 weeks

Study Arms (2)

CLE followed by standard EGD

ACTIVE COMPARATOR

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); Device: standard endoscopy (EGD)

standard EGD followed by CLE

ACTIVE COMPARATOR

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); Device: standard endoscopy (EGD)

Interventions

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.

Also known as: Pentax Confocal Laser Endomicroscope(EC3870KCILK)

CLE followed by standard EGD; standard EGD followed by CLE

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.

Also known as: Olympus upper endoscope (GIF160)

CLE followed by standard EGD; standard EGD followed by CLE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Barrett's esophagus or suspected Barrett's-associated neoplasia
• Age \> 18
• Able to give informed consent

You may not qualify if:

• Known advanced malignant disease
• Allergy to the fluorescent contrast agent fluorescein sodium
• Coagulopathy or bleeding disorder

Sponsors & Collaborators

• Johns Hopkins University: lead
• American Society for Gastrointestinal Endoscopy: collaborator
• Pentax, USA: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• 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.

  PMID: 19559419 RESULT

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Limitations and Caveats

Relatively small study (39 patients) and performed at a tertiary care, referral center, which can reduce generalizability.

Results Point of Contact

• Title: Dr. Marcia Canto.
• Organization: Johns Hopkins University School of Medicine Division of Gastroenterology and Hepatology

mcanto@jhmi.edu

410-614-5388

Study Officials

• Marcia I Canto, MD, MHS

  Division of Gastroenterology, Johns Hopkins University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2007
• First Posted: June 19, 2007
• Study Start: April 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: September 1, 2008
• Last Updated: June 22, 2021
• Results First Posted: August 17, 2011

Record last verified: 2021-06

Locations

US (1)