Confocal Endomicroscopy for Biliary Strictures -Phase I

Biliary Stricture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00892632
• Other study ID #: 08-008669
• Status: Terminated
• Phase: N/A
• First received: May 1, 2009
• Last updated: February 22, 2012
• Start date: April 2009
• Est. completion date: February 2011

Study information

• Verified date: February 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Biliary Stricture
• Cholestasis
• Constriction, Pathologic

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Sigma Tau Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Aim: 1. To compare confocal image characteristics of benign vs. malignant biliary strictures.		one year	No
Secondary	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.		One year	No