Diagnosis of Bile Duct Strictures

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02000999
First received: November 19, 2013
Last updated: May 27, 2014
Last verified: May 2014
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Specimen adequacy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • • Complications (pancreatitis, bleeding, perforation, cholangitis) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • • Technical success and ease of procedure [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: November 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02000999     History of Changes
Other Study ID Numbers: Cytology 2013
Study First Received: November 19, 2013
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Pancreatitis, Chronic
Pancreatic Neoplasms
Pancreatitis
Cholangiocarcinoma
Constriction, Pathologic
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

ClinicalTrials.gov processed this record on August 28, 2014