NCT02000999

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2019

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

5.2 years

First QC Date

November 19, 2013

Last Update Submit

May 10, 2019

Conditions

Bile Duct StrictureCholangiocarcinomaPancreatic CancerChronic Pancreatitis

Keywords

Bile duct strictureCholangiocarcinomaPancreatic cancerChronic pancreatitis

Outcome Measures

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.

    2 years

Secondary Outcomes (3)

  • • Specimen adequacy

    2 years

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

    2 years

  • • Technical success and ease of procedure

    2 years

Study Arms (1)

Patients with bile duct strictures

Other: brushing of bile duct strictures for cytology

Interventions

brushing of bile duct strictures for cytologyOTHER
Patients with bile duct strictures

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients over the age of 18 undergoing ERCP for the diagnosis and treatment of bile duct stricture

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

CholangiocarcinomaPancreatic NeoplasmsPancreatitis, Chronic

Interventions

Cytological Techniques

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesPancreatitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2013

First Posted

December 4, 2013

Study Start

November 1, 2013

Primary Completion

January 2, 2019

Study Completion

January 2, 2019

Last Updated

May 13, 2019

Record last verified: 2019-05

Locations

US(1)