Factors Predicting Positive Yields on Biliary Brush Cytology During Endoscopic Retrograde Cholangiopancreatography (ERCP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00894348
First received: May 5, 2009
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

To determine factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP.


Condition
Biliary Stricture

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: EXEMPT: Prospective Factors Predicting Positive Yields on Biliary Brush Cytology During Endoscopic Retrograde Cholangio-pancreatography (ERCP)

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • To determine factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP determine the factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

There are only 3 studies available that have tried to evaluate factors influencing the yield of brush cytology. Two of the 3 studied one parameter. The third study, which is also the largest, reported on 199 samples which the authors evaluated in a retrospect fashion. We plan to conduct a larger study assessing several other factors that have not been studied before. The study findings would help develop strategies to improve sensitivity of brush cytology specimens. This would ultimately result in more effective use of health care resources and improve patient outcomes.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing an ERCP for evaluation of biliary strictures

Criteria

Inclusion Criteria:

  • ERCP Patients

Exclusion Criteria:

  • Non ERCP Patients
  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: NCT00894348

Contacts
Contact: Adele Costanzo, RN 216/445-3851 costana@ccf.org

Locations
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Adele Costanzo       costana@ccf.org   
Principal Investigator: Mansour Parsi, M.D         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Adele Costanzo, RN    216-445-3851      
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Adele Costanzo, RN    216-445-3851      
Principal Investigator: Mansour Parsi, M.D         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Mansour Parsi, M.D. Staff Physician
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00894348     History of Changes
Other Study ID Numbers: IRB 09-032
Study First Received: May 5, 2009
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
ERCP
Positive Biliary Brush Cytology
To determine factors associated with the positive yield of malignancy on biliary brush cytology obtained by ERCP

ClinicalTrials.gov processed this record on October 22, 2014