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
  Purpose

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).


Condition
Cholangiocarcinoma
Bile Duct Inflammation

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

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 ] [ 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


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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: April 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
pCLE
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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
  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: NCT01392274

Contacts
Contact: Adam Sliva, MD (412) 647-8132 slivax@UPMC.EDU

Locations
United States, Connecticut
Yale new Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Priya Jamidar, MD       priya.jamidar@yale.edu   
United States, New York
New York presbyterian Weill Cornell Medical center Recruiting
New york, New York, United States, 10065
Contact: Michel Kahaleh, MD       MK5KE@hscmail.mcc.virginia.edu   
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Adam Slivka, MD    412-647-8132    slivax@UPMC.EDU   
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98111
Contact: Ian Gan, MD    206-223-2319    seng-ian.gan@vmmc.org   
France
Institut Paoli Calmettes Recruiting
Marseille, France, 13000
Contact: Marc Giovannini, MD       giovannini@wanadoo.fr   
Italy
Policlinico Univertitario Agostino Gemelli Recruiting
Roma, Italy, 00168
Contact: Guido Costamagna, Prof       gcostamagna@rm.unicatt.it   
Sponsors and Collaborators
Mauna Kea Technologies
Investigators
Principal Investigator: Adam Slivka, MD University of Pittsburh Medical Center
  More Information

No publications provided

Responsible Party: Mauna Kea Technologies
ClinicalTrials.gov Identifier: NCT01392274     History of Changes
Other Study ID Numbers: MKT-2011-FOCUS
Study First Received: July 7, 2011
Last Updated: April 24, 2013
Health Authority: United States: Institutional Review Board
Germany: German Institute of Medical Documentation and Information
France: National Consultative Ethics Committee for Health and Life Sciences
Italy: Ethics Committee

Additional relevant MeSH terms:
Cholangitis
Inflammation
Cholangiocarcinoma
Pathologic Processes
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014