NCT01392274

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2012

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

1.4 years

First QC Date

July 7, 2011

Last Update Submit

December 2, 2014

Conditions

CholangiocarcinomaBile Duct Inflammation

Outcome Measures

Primary Outcomes (1)

  • Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l

    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

    12 months

Secondary Outcomes (1)

  • Comparative histopathology-confirmed measures of Cellvizio endomicroscopy and ERCP accuracy in the differential diagnosis of suspicious l

    12 months follow-up

Study Arms (1)

pCLE

This trial will study only one group which will receive a standard ERCP procedure followed by pCLE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Yale new Haven Hospital

New Haven, Connecticut, 06510, United States

Location

New York presbyterian Weill Cornell Medical center

New York, New York, 10065, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98111, United States

Location

Institut Paoli Calmettes

Marseille, 13000, France

Location

Policlinico Univertitario Agostino Gemelli

Roma, 00168, Italy

Location

Related Publications (1)

  • Slivka A, Gan I, Jamidar P, Costamagna G, Cesaro P, Giovannini M, Caillol F, Kahaleh M. Validation of the diagnostic accuracy of probe-based confocal laser endomicroscopy for the characterization of indeterminate biliary strictures: results of a prospective multicenter international study. Gastrointest Endosc. 2015 Feb;81(2):282-90. doi: 10.1016/j.gie.2014.10.009.

    PMID: 25616752DERIVED

MeSH Terms

Conditions

CholangiocarcinomaCholangitis

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Adam Slivka, MD

    University of Pittsburh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2011

First Posted

July 12, 2011

Study Start

April 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

FR(1)IT(1)US(4)