Confocal Endomicroscopy for Biliary Strictures -Phase I

This study has been terminated.
(Difficult (slow) Enrollment)
Sponsor:
Collaborator:
Sigma Tau Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Michael Wallace, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00892632
First received: May 1, 2009
Last updated: February 22, 2012
Last verified: February 2012
  Purpose

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892632

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Sigma Tau Pharmaceuticals, Inc.
Investigators
Principal Investigator: Michael B. Wallace, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Michael Wallace, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00892632     History of Changes
Other Study ID Numbers: 08-008669
Study First Received: May 1, 2009
Last Updated: February 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Biliary Strictures
Cholangiocarcinoma
ERCP

Additional relevant MeSH terms:
Cholestasis
Constriction, Pathologic
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 28, 2014