Clinical trial NCT00892632: Confocal Endomicroscopy for Biliary Strictures -Phase I
Official title: A Pilot Study of Confocal Endomicroscopy for Biliary Strictures - Phase I
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Biliary Stricture
Keywords: Biliary Strictures
Cholangiocarcinoma
ERCP
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Leadiant Biosciences, Inc.
First posted: 2009-05-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Aim: 1. To compare confocal image characteristics of benign vs. malignant biliary strictures.
timeFrame: one year
Secondary outcomes:
measure: 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.
timeFrame: One year
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Michael B. Wallace, M.D.
role: PRINCIPAL_INVESTIGATOR
References: