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pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture (FOCUS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Mauna Kea Technologies
Sponsor:
Information provided by (Responsible Party):
Mauna Kea Technologies
ClinicalTrials.gov Identifier:
NCT01392274
First received: July 7, 2011
Last updated: April 24, 2013
Last verified: April 2013

July 7, 2011
April 24, 2013
April 2012
May 2013   (final data collection date for primary outcome measure)
Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Evaluation of pCLE diagnostic performance for the diagnosis of indeterminate biliary stricture (ie. number of patients accurately diagnosed) when associated with other diagnostic information The following calculations will be conducted: sensitivity, specificity, positive and negative predictive values, Accuracy
Same as current
Complete list of historical versions of study NCT01392274 on ClinicalTrials.gov Archive Site
Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l [ Time Frame: 12 months follow-up ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture
pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture

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).

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Bile Duct Cancers

  • Cholangiocarcinoma
  • Bile Duct Inflammation
Not Provided
pCLE
This trial will study only one group which will receive a standard ERCP procedure followed by pCLE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
September 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Adam Sliva, MD (412) 647-8132 slivax@UPMC.EDU
United States,   France,   Italy
 
NCT01392274
MKT-2011-FOCUS
No
Mauna Kea Technologies
Mauna Kea Technologies
Not Provided
Principal Investigator: Adam Slivka, MD University of Pittsburh Medical Center
Mauna Kea Technologies
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP