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A Pilot Study of Confocal Endomicroscopy for Biliary Strictures - Phase I

18 Years
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Biliary Stricture

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Trial Information

A Pilot Study of Confocal Endomicroscopy for Biliary Strictures - Phase I

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.

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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Primary Aim: 1. To compare confocal image characteristics of benign vs. malignant biliary strictures.

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Michael B. Wallace, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Institutional Review Board

Study ID:




Start Date:

April 2009

Completion Date:

February 2011

Related Keywords:

  • Biliary Stricture
  • Biliary Strictures
  • Cholangiocarcinoma
  • ERCP
  • Cholestasis
  • Constriction, Pathologic



Mayo Clinic Jacksonville, Florida  32224