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

NCT ID: NCT01565460

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2016-12-31

Brief Summary

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.

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.

Conditions

Pancreatic Duct Strictures; Biliary Duct Strictures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

pancreatic/biliary strictures

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

Sample Collection

Intervention Type: OTHER

Sample Collection: bile and pancreatic duct brushings and fluid samples will be obtained from the pancreatic stricture during endoscopic retrograde cholangiopancreatic procedure.

Interventions

Sample Collection

Sample Collection: bile and pancreatic duct brushings and fluid samples will be obtained from the pancreatic stricture during endoscopic retrograde cholangiopancreatic procedure.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mansour Parsi, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Udayakumar Navaneethan, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

Navaneethan U, Parsi MA, Lourdusamy V, Bhatt A, Gutierrez NG, Grove D, Sanaka MR, Hammel JP, Stevens T, Vargo JJ, Dweik RA. Volatile organic compounds in bile for early diagnosis of cholangiocarcinoma in patients with primary sclerosing cholangitis: a pilot study. Gastrointest Endosc. 2015 Apr;81(4):943-9.e1. doi: 10.1016/j.gie.2014.09.041. Epub 2014 Dec 12.

Reference Type: DERIVED

PMID: 25500329 (View on PubMed)

Navaneethan U, Parsi MA, Gutierrez NG, Bhatt A, Venkatesh PG, Lourdusamy D, Grove D, Hammel JP, Jang S, Sanaka MR, Stevens T, Vargo JJ, Dweik RA. Volatile organic compounds in bile can diagnose malignant biliary strictures in the setting of pancreatic cancer: a preliminary observation. Gastrointest Endosc. 2014 Dec;80(6):1038-45. doi: 10.1016/j.gie.2014.04.016. Epub 2014 Jun 11.

Reference Type: DERIVED

PMID: 24929484 (View on PubMed)

Other Identifiers

11-976

Identifier Type: -

Identifier Source: org_study_id