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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mansour Parsi, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00894348
First received: May 5, 2009
Last updated: March 29, 2017
Last verified: March 2017
  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: Observational Model: Other
Time Perspective: Prospective
Official Title: EXEMPT: Prospective Factors Predicting Positive Yields on Biliary Brush Cytology During Endoscopic Retrograde Cholangio-pancreatography (ERCP)

Further study details as provided by Mansour Parsi, MD, 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 ]

Enrollment: 200
Study Start Date: January 2009
Study Completion Date: December 2013
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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Mansour Parsi, M.D. Staff Physician
  More Information

Responsible Party: Mansour Parsi, MD, MD, 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: March 29, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Mansour Parsi, MD, The Cleveland Clinic:
ERCP
Positive Biliary Brush Cytology

ClinicalTrials.gov processed this record on June 27, 2017