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Completed

NCT Number: NCT02000999

Diagnosis of Bile Duct Strictures

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.

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Key information

Conditions

Bile Duct Stricture Adenocarcinoma Carcinoma Cholangiocarcinoma Chronic Disease Chronic Pancreatitis Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

brushing of bile duct strictures for cytology

Other

Primary outcomes

  1. • 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 outcomes

  1. • Specimen adequacy

    Time frame: 2 years

  2. • Complications (pancreatitis, bleeding, perforation, cholangitis)

    Time frame: 2 years

  3. • Technical success and ease of procedure

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2013
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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