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

NeuroTherapia, Inc.

Status: Completed

Conditions: Pancreatic Duct Strictures; Biliary Duct Strictures

Treatments: Other: Sample Collection

Study type: Observational

Funder types: Other

Identifiers

NCT01565460

11-976

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

pancreatic/biliary strictures

Description:

Sample Collection: Patients with pancreatic/biliary stricture undergoing intervention will have samples of brushings and bile taken during the procedure.

Treatment:

Other: Sample Collection