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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01565460
First received: March 26, 2012
Last updated: February 12, 2013
Last verified: February 2013
  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 The Cleveland Clinic:

Biospecimen Retention:   Samples With DNA

Bile and bile duct/pancreatic duct brushings


Estimated Enrollment: 500
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with pancreatic/biliary strictures
Patients with pancreatic/biliary stricture undergoing intervention will have samples of brushings and bile taken during the procedure.
Other: 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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
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: NCT01565460

Contacts
Contact: Udayakumar Navaneethan, MD 216/636-9561 navaneu@ccf.org
Contact: Mansour Parsi, MD 216-445-5880 parsim@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Udayakumar Navaneethan, MD    216-636-9230    navaneu@ccf.org   
Contact: Susan Thomas, RN    216-444-5930    thomass4@ccf.org   
Principal Investigator: Udayakumar Navaneethan, MD         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Udayakumar Navaneethan, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01565460     History of Changes
Other Study ID Numbers: 11-976
Study First Received: March 26, 2012
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
pancreas
biliary
stricture

Additional relevant MeSH terms:
Cholestasis
Constriction, Pathologic
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 20, 2014