NCT00779688

Brief Summary

This registry will collect data from patients routinely undergoing an ERCP and Cellvizio endomicroscopy procedure (and optionally an additional cholangiopancreatoscopy procedure) due to suspected pancreatic or bile duct cancer. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2008

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

October 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

February 10, 2011

Status Verified

February 1, 2011

Enrollment Period

10 months

First QC Date

October 22, 2008

Last Update Submit

February 9, 2011

Conditions

Pancreatic CancerBile Duct Cancer

Keywords

Endoscopic Retrograde CholangiopancreatographyERCPbile duct cancerpancreatic duct cancergall bladderpancreasduodenoscopeCellvizioendomicroscopycholangiopancreatoscopyBiliary Tract Neoplasms (suspected)Biliary Tract Mass (suspected)Biliary Tract Stricture (suspected)Pancreatic Duct Neoplasms (suspected)Pancreatic Duct Mass (suspected)Pancreatic Duct Stricture (suspected)

Outcome Measures

Primary Outcomes (1)

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

    12-month diagnostic follow-up confirmation

Interventions

Probe-based confocal laser endomicroscopyDEVICE

ERCP with or without cholangiopancreatoscopy will be performed by the endoscopist as clinically indicated. If findings at ERCP and/or prior imaging studies and/or clinical assessment suggest possible malignancy and/or an indeterminate biliary or pancreatic pathology Cellvizio probe-based endomicroscopy will be performed during ERCP.

Also known as: Cellvizio endomicroscopy, Confocal Laser Scanning Microscopy

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 Pancreatic and Bile Duct Cancers

You may qualify if:

  • Male or female \> 18 years of age
  • Willing and able to comply with Registry procedures and provide written informed consent to participate in the Registry
  • Indicated for ERCP and/or cholangiopancreatoscopy
  • Indeterminate or suspected biliary and/or pancreatic stricture, mass, or neoplasm

You may not qualify if:

  • Subjects for whom ERCP procedures are contraindicated
  • Known allergy to fluorescein dye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

New York Presbyterian Hospital/Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Institut Paoli-Calmettes

Marseille, 13273, France

Location

Klinikum rechts der Isar

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsBile Duct NeoplasmsBiliary Tract Neoplasms

Interventions

Microscopy, Confocal

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesBile Duct DiseasesBiliary Tract Diseases

Intervention Hierarchy (Ancestors)

MicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Yang Chen, MD, FACP, FACG

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 24, 2008

Study Start

November 1, 2008

Primary Completion

September 1, 2009

Study Completion

October 1, 2010

Last Updated

February 10, 2011

Record last verified: 2011-02

Locations

FR(1)DE(1)US(4)