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Bile and Bile Duct/Pancreatic Duct Brushings Database for Patients With Pancreato-biliary Stricture

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01565460
First Posted: March 28, 2012
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mansour Parsi, MD, The Cleveland Clinic
  Purpose

The purpose of this study is to create a long-term storage of bile and brushings of pancreato-biliary duct in patients diagnosed with pancreato-biliary stricture for future research.

Recently, a lot of research has been done to test for certain markers in the bile and brushings to detect cancer in a stricture. The samples will be used to measure biomarkers (proteins) in biliary diseases.


Condition Intervention
Pancreatic Duct Strictures Biliary Duct Strictures Other: Sample Collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bile and Bile Duct/Pancreatic Duct Brushings Database for Patients With Pancreato-biliary Stricture

Further study details as provided by Mansour Parsi, MD, The Cleveland Clinic:

Biospecimen Retention:   Samples With DNA
Bile and bile duct/pancreatic duct brushings

Enrollment: 200
Study Start Date: February 2012
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
pancreatic/biliary strictures
Sample Collection: Patients with pancreatic/biliary stricture undergoing intervention will have samples of brushings and bile taken during the procedure.
Other: Sample Collection
Sample Collection: bile and pancreatic duct brushings and fluid samples will be obtained from the pancreatic stricture during endoscopic retrograde cholangiopancreatic procedure.

Detailed Description:
Recently, a lot of research has been done to test for certain markers like fluorescence in situ hybridization (FISH), digital image analysis (DIA), and quantifiable morphometric results in biliary stricture brushings. Recently, polysomy FISH has been studied as a promising marker in predicting cancer in a pancreato-biliary stricture. Many genetic, epigenetic, and protein alterations arise during pancreaticobiliary tumor process. The types of markers that have been commonly evaluated as diagnostic assays are mutations, chromosomal gains and losses, and DNA methylation alterations. However there are only a few studies in this area. Testing for these markers can help determine whether the narrowing or stricture in your bile duct is cancer or not.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with pancreatic or biliary duct stricture who present for evaluation and intervention of their stricture
Criteria

Inclusion Criteria:

  • Any patient diagnosed with pancreato-biliary stricture.
  • Age >18 years
  • Ability to provide an informed consent

Exclusion Criteria:

  • Patients with altered mental status, who will not be able to provide an informed consent
  • Pregnant women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565460


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Udayakumar Navaneethan, MD The Cleveland Clinic
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mansour Parsi, MD, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01565460     History of Changes
Other Study ID Numbers: 11-976
First Submitted: March 26, 2012
First Posted: March 28, 2012
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mansour Parsi, MD, The Cleveland Clinic:
pancreas
biliary
stricture

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical