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

NCT01565460 | Completed

• 1 other identifier: 11-976
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Duct Strictures; Biliary Duct Strictures

Keywords

pancreas; biliary; stricture

Study Arms (1)

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

Interventions

Sample Collection OTHER

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

pancreatic/biliary strictures

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with pancreatic or biliary duct stricture who present for evaluation and intervention of their stricture

You may qualify if:

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

You may not qualify if:

• Patients with altered mental status, who will not be able to provide an informed consent
• Pregnant women

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (2)

• 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.

  PMID: 25500329 DERIVED

• 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.

  PMID: 24929484 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Bile and bile duct/pancreatic duct brushings

MeSH Terms

Conditions

Constriction, Pathologic

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Udayakumar Navaneethan, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 28, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 30, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)