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Diagnosis of Bile Duct Strictures

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Washington University School of Medicine.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02000999
First Posted: December 4, 2013
Last Update Posted: June 3, 2015
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):
Washington University School of Medicine
  Purpose

The purpose of this prospective study is to compare the diagnostic utility of two techniques (brush cytology + FISH and brush cytology + free DNA analysis) in the diagnosis of biliary strictures. Histologic diagnosis (biopsies) in conjunction with clinical and/or imaging follow-up will serve as the gold standard for diagnosis of malignancy. In order to do this the investigators will ask study participants to have a small volume of fluid obtained from the bile duct sent for additional testing at RedPATH. In some patients additional brushings will be obtained for FISH testing (this adds <2 minutes to ERCP and only associated risk is increased procedure duration).

The investigators hypothesize that the use of cytology +DNA analysis has a higher sensitivity and accuracy when compared to cytology +FISH in patients with biliary strictures.

Primary aim:

To compare the sensitivity and accuracy of the two techniques (brush cytology + FISH and brush cytology + free DNA analysis). Histologic diagnosis (histology from biopsy or cytology for fine needle aspiration) in conjunction with clinical and/or imaging follow-up will serve as the gold standard for diagnosis of malignancy.

Secondary aims:

  1. To evaluate the diagnostic yield of malignancy when all three techniques (cytology, FISH and DNA analysis) are used.
  2. To evaluate the added value of biliary forceps biopsies, when used in conjunction with cytology, FISH and DNA analysis.

Condition Intervention
Bile Duct Stricture Cholangiocarcinoma Pancreatic Cancer Chronic Pancreatitis Other: brushing of bile duct strictures for cytology

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Diagnostic Yield of Malignancy Comparing Cytology, FISH and Molecular Analysis of Cell Free Cytology Brush Supernatant in Patients With Biliary Strictures Undergoing Endoscopic Retrograde Cholangiography (ERC): A Prospective Study

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • • Sensitivity accuracy of cytology, FISH and mutation profiling using histologic diagnosis in conjunction with clinical and/or imaging follow-up as the gold standard. [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • • Specimen adequacy [ Time Frame: 2 years ]
  • • Complications (pancreatitis, bleeding, perforation, cholangitis) [ Time Frame: 2 years ]
  • • Technical success and ease of procedure [ Time Frame: 2 years ]

Estimated Enrollment: 110
Study Start Date: November 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with bile duct strictures Other: brushing of bile duct strictures for cytology

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients over the age of 18 undergoing ERCP for the diagnosis and treatment of bile duct stricture
Criteria

Inclusion Criteria:

  1. Patients age: > 18 years
  2. Presence of a biliary stricture
  3. Ability to provide written informed consent.

Exclusion Criteria:

  1. Severe coagulopathy (INR > 1.8) or thrombocytopenia (platelet count <50,000)
  2. Inability to cannulate the common bile duct
  3. Presence of altered anatomy (Billroth II or Roux-en-Y reconstruction)
  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): NCT02000999


Locations
United States, Missouri
Washington University Recruiting
St Louis, Missouri, United States, 63110
Contact: Vladimir M Kushnir, MD    314-454-5960      
Principal Investigator: Vladimir M Kushnir, MD         
Sponsors and Collaborators
Washington University School of Medicine
  More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02000999     History of Changes
Other Study ID Numbers: Cytology 2013
First Submitted: November 19, 2013
First Posted: December 4, 2013
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by Washington University School of Medicine:
Bile duct stricture
Cholangiocarcinoma
Pancreatic cancer
Chronic pancreatitis

Additional relevant MeSH terms:
Pancreatic Neoplasms
Pancreatitis
Cholangiocarcinoma
Constriction, Pathologic
Pancreatitis, Chronic
Cholestasis
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases