Confocal Endomicroscopy for Biliary Strictures -Phase I
The investigators hypothesize that the confocal endomicroscopy imaging of the biliary strictures during ERCP will differentiate between benign and malignant strictures in vivo and has increased sensitivity compared to biliary brushing/biopsy, and that direct cholangioscopic guidance of pCLE is more accurate than fluoroscopic guidance.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Pilot Study of Confocal Endomicroscopy for Biliary Strictures - Phase I|
- Primary Aim: 1. To compare confocal image characteristics of benign vs. malignant biliary strictures. [ Time Frame: one year ] [ Designated as safety issue: No ]
- Secondary Aim: 1. To compare the technical feasibility (percentage of images rated as adequate or better) and the quality of the images obtained via fluoroscopy-guided pCLE versus cholangioscopy-guided pCLE. [ Time Frame: One year ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
1. To compare confocal image characteristics of benign vs. malignant biliary strictures
Procedure: ERCP and Confocal imaging
A major new advancement in cancer imaging is the development of a probe-based confocal endomicroscopy (pCLE) system capable of cellular and sub-cellular imaging of the biliary tree.
Despite recent advances in biliary imaging and biliary tissue acquisition, the diagnosis and tissue-confirmation in suspected malignant biliary obstruction remains challenging. Patients often undergo repeat endoscopic and cross sectional imaging procedures, and even surgical exploration to establish a diagnosis. A major new advancement in cancer imaging is the development of a probe-based confocal endomicroscopy (pCLE) system capable of cellular and sub-cellular imaging of the biliary tree. Preliminary data suggests that pCLE can accurately detect or exclude malignancy within otherwise indeterminate strictures. In this study, we propose to validate these preliminary findings and compare two methods of pCLE image acquisition that are important for clinical translation of the technology.
This is a Phase 1 Study: During this study, in vivo microscopic images of 10 benign (post-operative from know benign disease such as orthotopic liver transplant) and 10 malignant (cytology-positive) strictures will be obtained at ERCP. Patients clinical course will be followed and a composite gold standard will be used for comparison to pCLE. These confocal images of biliary lesions will be reviewed side by side, unblinded to the reference standard by the endoscopists. The basic image characteristics allowing distinction between benign and malignant tissue will be established (details of features noted and examined are below). We will also assess whether good quality images can be feasibly obtained without the cholangioscopic guidance.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00892632
|United States, Florida|
|Jacksonville, Florida, United States, 32224|
|Principal Investigator:||Michael B. Wallace, M.D.||Mayo Clinic|