Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy (DONTBIOPCE)
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ClinicalTrials.gov Identifier: NCT00795184 |
Recruitment Status :
Completed
First Posted : November 21, 2008
Results First Posted : May 3, 2016
Last Update Posted : May 3, 2016
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Condition or disease | Intervention/treatment | Phase |
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Barrett Syndrome Barrett's Syndrome Barrett's Esophagus Barrett Esophagus Adenocarcinoma | Device: Imaging procedures (NBI) Device: HDWLE Device: pCLE | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 122 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy |
Study Start Date : | November 2008 |
Actual Primary Completion Date : | September 2009 |
Actual Study Completion Date : | February 2010 |
Arm | Intervention/treatment |
---|---|
Imaging Procedures HDWLE first NBI second and pCLE
All patients undergo both endoscopic imaging procedures and then the endomicroscopy procedure; the endoscopic imaging procedures being performed back to back by two endoscopists, blinded to each other.
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Device: Imaging procedures (NBI)
Imaging procedures (pCLE) and (NBI) - All patients undergo both procedures back to back by two endoscopists, blinded to each other, in randomized order. Procedure 1: Standard endoscopic procedure The patient receives white light endoscopy (WLE) examination. All visible lesions are noted and photographed. No biopsy is taken until both procedures are complete. Procedure 2: NBI endoscopic procedure The patient receives a NBI endoscopy examination. All visible and NBI abnormal lesions are noted and photographed. After both procedures are complete and all sites are unblinded to both endoscopists. pCLE with Cellvizio and physical biopsies are performed at all sites plus 4 quadrant sites. Device: HDWLE Device: pCLE Other Name: Cellvizio |
Imaging Procedures NBI first HDWLE second and pCLE
All patients undergo both endoscopic imaging procedures and then the endomicroscopy procedure; the endoscopic imaging procedures being performed back to back by two endoscopists, blinded to each other.
|
Device: Imaging procedures (NBI)
Imaging procedures (pCLE) and (NBI) - All patients undergo both procedures back to back by two endoscopists, blinded to each other, in randomized order. Procedure 1: Standard endoscopic procedure The patient receives white light endoscopy (WLE) examination. All visible lesions are noted and photographed. No biopsy is taken until both procedures are complete. Procedure 2: NBI endoscopic procedure The patient receives a NBI endoscopy examination. All visible and NBI abnormal lesions are noted and photographed. After both procedures are complete and all sites are unblinded to both endoscopists. pCLE with Cellvizio and physical biopsies are performed at all sites plus 4 quadrant sites. Device: HDWLE Device: pCLE Other Name: Cellvizio |
- Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. [ Time Frame: Centralized histopathology confirmation within 4-6 weeks ]Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using Probe-based Confocal Laser Endomicroscopy (pCLE) Associated With White Light Endoscopy (WLE), or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with documented or suspected Barrett's esophagus presenting for endoscopy
- Age > 18 years
- Ability to provide written, informed consent
Exclusion Criteria:
- Presence of erosive esophagitis
- Inability to obtain biopsies due to anticoagulation, varices, etc.
- Allergy to fluorescein, pregnancy
- Presence of an esophageal mass other than small 10mm or less nodules
- Renal insufficiency

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795184
United States, Florida | |
Mayo Clinic | |
Jacksonville, Florida, United States, 32224 | |
United States, Missouri | |
Veterans Affairs Hospital | |
Kansas City, Missouri, United States, 64128 | |
United States, New York | |
New York Presbyterian Hospital/Columbia University Medical Center | |
New York, New York, United States, 10032 | |
France | |
Centre Hospitalier Universitaire | |
Nantes, France, 44093 Cedex 1 | |
Germany | |
Klinikum rechts der Isar | |
Munich, Bayern, Germany |
Principal Investigator: | Prateek Sharma, MD | Veterans Affairs Hospital, Kansas City |
Responsible Party: | Mauna Kea Technologies |
ClinicalTrials.gov Identifier: | NCT00795184 |
Other Study ID Numbers: |
MKT-2008-BE-01 |
First Posted: | November 21, 2008 Key Record Dates |
Results First Posted: | May 3, 2016 |
Last Update Posted: | May 3, 2016 |
Last Verified: | May 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Barrett's Esophagus EsoGastroDuodenoscopy Barrett's Carcinoma adenocarcinoma |
Cellvizio endomicroscopy random biopsy |
Adenocarcinoma Barrett Esophagus Syndrome Disease Pathologic Processes Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Precancerous Conditions Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |