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

This study has been completed.
Information provided by (Responsible Party):
Mauna Kea Technologies Identifier:
First received: July 7, 2011
Last updated: December 2, 2014
Last verified: December 2014
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).

Bile Duct Inflammation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture

Resource links provided by NLM:

Further study details as provided by Mauna Kea Technologies:

Primary Outcome Measures:
  • Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l [ Time Frame: 12 months ]
    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

Secondary Outcome Measures:
  • Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l [ Time Frame: 12 months follow-up ]

Enrollment: 121
Study Start Date: April 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
This trial will study only one group which will receive a standard ERCP procedure followed by pCLE

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Bile Duct Cancers

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
  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 identifier: NCT01392274

United States, Connecticut
Yale new Haven Hospital
New Haven, Connecticut, United States, 06510
United States, New York
New York presbyterian Weill Cornell Medical center
New york, New York, United States, 10065
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98111
Institut Paoli Calmettes
Marseille, France, 13000
Policlinico Univertitario Agostino Gemelli
Roma, Italy, 00168
Sponsors and Collaborators
Mauna Kea Technologies
Principal Investigator: Adam Slivka, MD University of Pittsburh Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mauna Kea Technologies Identifier: NCT01392274     History of Changes
Other Study ID Numbers: MKT-2011-FOCUS
Study First Received: July 7, 2011
Last Updated: December 2, 2014

Additional relevant MeSH terms:
Constriction, Pathologic
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases processed this record on May 25, 2017