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Confocal Endomicroscopy for Biliary Strictures -Phase I

This study has been terminated.
(Difficult (slow) Enrollment)
Leadiant Biosciences, Inc.
Information provided by (Responsible Party):
Michael Wallace, Mayo Clinic Identifier:
First received: May 1, 2009
Last updated: February 22, 2012
Last verified: February 2012
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.

Condition Intervention
Biliary Stricture
Procedure: ERCP and Confocal imaging

Study Type: Interventional
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

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Primary Aim: 1. To compare confocal image characteristics of benign vs. malignant biliary strictures. [ Time Frame: one year ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: April 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pre-ERCP: Age above 18; imaging consistent with stenosis/mass of the hilum/extra-hepatic bile duct with abnormal liver chemistry, or painless jaundice referred for ERCP.
  • Evidence of biliary obstruction as defined by elevated direct bilirubin (> 1.5ULN) and dilation of the common or hepatic ducts > 8mm) on imaging studies.

Exclusion Criteria:

  • Unwilling/unable to consent.
  • Definite pancreatic mass on CT/MR.
  • Allergy to Fluorescein.
  • Pregnancy (patient who could be pregnant will undergo pregnancy testing as per routine care)
  • Indwelling metal biliary stent.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00892632

United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Leadiant Biosciences, Inc.
Principal Investigator: Michael B. Wallace, M.D. Mayo Clinic
  More Information

Responsible Party: Michael Wallace, M.D., Mayo Clinic Identifier: NCT00892632     History of Changes
Other Study ID Numbers: 08-008669
Study First Received: May 1, 2009
Last Updated: February 22, 2012

Keywords provided by Mayo Clinic:
Biliary Strictures

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases processed this record on April 28, 2017