Brief Title
pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture
Official Title
pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture
Brief Summary
This study will collect data from patients undergoing an ERCP procedure with probe-based
Confocal Laser Endomicroscopy for suspicion of bile duct cancer. the objective is to evaluate
the diagnostic performance of pCLE for the diagnosis of indeterminate biliary stricture when
associated with other diagnostic information (standard ERCP and tissue sampling).
Detailed Description
This trial aims at evaluating the performance diagnosis of pCLE for the detection of bile
duct cancer, in patients with indeterminate biliary stricture when associated with other
diagnostic information.
The hypothesis is that ERCP with Cellvizio probe-based endomicroscopy improves
differentiation of biliary and pancreatic duct lesions versus ERCP alone or ERCP with tissue
sampling, by improving the sensitivity of detection and by providing a real-time diagnosis.
Direct measures of accuracy (sensitivity, specificity, etc.) in the differentiation of
malignant versus benign biliary duct lesions will be compared for the combination of ERCP
alone, endomicroscopy plus ERCP imaging, and ERCP plus endomicroscopy plus tissue sampling.
These information will be reviewed retrospectively by a second physician.
These presumptive diagnoses will be compared against a 12-month follow-up confirmed
histopathologic endpoint (an initially-benign pathologic diagnosis will be confirmed by a
12-month follow-up). Secondary objectives include collecting patient management
recommendation. Yet, effective management recommendation is left as the discretion of the
physician.
Study Type
Observational
Primary Outcome
Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l
Secondary Outcome
Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l
Condition
Cholangiocarcinoma
Study Arms / Comparison Groups
pCLE
Description: This trial will study only one group which will receive a standard ERCP procedure followed by pCLE
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
121
Start Date
April 2012
Completion Date
September 2013
Primary Completion Date
September 2013
Eligibility Criteria
Inclusion Criteria:
- Male or female > 18 years of age
- Indicated for ERCP for indeterminate bile duct stricture
- Referral patients with indeterminate biliary stricture coming in for first ERCP
procedure at referral institution or
- Patients who had previous non-diagnostic tissue sampling (brushing biopsies or
EUS-FNA) taken during a previous ERCP or EUS-FNA for an indeterminate biliary
stricture
- Willing and able to comply with study procedures and provide written informed consent
to participate in the study
Exclusion Criteria:
- Subjects for whom ERCP procedures are contraindicated
- Known allergy to fluorescein dye
- Patients suffering Primary Sclerosing Cholangitis or chronic pancreatitis.
- Patients with post-transplant stricture
- If female, pregnant based on a positive hCG serum or an in vitro diagnostic test
result or breast-feeding
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Adam Slivka, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT01392274
Organization ID
MKT-2011-FOCUS
Responsible Party
Sponsor
Study Sponsor
Mauna Kea Technologies
Study Sponsor
Adam Slivka, MD, Principal Investigator, University of Pittsburh Medical Center
Verification Date
December 2014