Bile Duct StrictureNCT02000999
Diagnosis of Bile Duct Strictures
An observational study of Bile Duct Stricture and Cholangiocarcinoma, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bile Duct Stricture, Cholangiocarcinoma, Pancreatic Cancer
- What is being tested?
- brushing of bile duct strictures for cytology
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 2 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 18 undergoing ERCP for the diagnosis and treatment of bile duct stricture
Who may be able to join
- Patients age: > 18 years
- Presence of a biliary stricture
- Ability to provide written informed consent.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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:
- To evaluate the diagnostic yield of malignancy when all three techniques (cytology, FISH and DNA analysis) are used.
- To evaluate the added value of biliary forceps biopsies, when used in conjunction with cytology, FISH and DNA analysis.
- Being tested
- brushing of bile duct strictures for cytology
- Keywords
- Bile duct stricture, Cholangiocarcinoma, Pancreatic cancer, Chronic pancreatitis
- Medical subject headings
- Cholangiocarcinoma, Pancreatic Neoplasms, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brushing of bile duct strictures for cytologyOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with bile duct strictures | Not described Receives: Other: brushing of bile duct strictures for cytology |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Sensitivity accuracy of cytology, FISH and mutation profiling using histologic diagnosis in conjunction with clinical and/or imaging follow-up as the gold standard.
Measured: 2 years
Secondary outcomes (3)
• Specimen adequacy
Measured: 2 years
• Complications (pancreatitis, bleeding, perforation, cholangitis)
Measured: 2 years
• Technical success and ease of procedure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startNov 2013
- Primary completion2 Jan 2019
- Study completion2 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct StrictureStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000999
- Sponsor's protocol ID
- Cytology 2013-201211068
- Status last verified
- May 2019
- First submitted
- 19 Nov 2013
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02000999
- Acronym / sponsor ID
- Cytology 2013-201211068
- Keywords
- Bile duct stricture, Cholangiocarcinoma, Pancreatic cancer, Chronic pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- 2 Jan 2019 (actual)
- Study completion
- 2 Jan 2019 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the diagnostic yield of malignancy when all three techniques (cytology, FISH and DNA analysis) are used.
- To evaluate the added value of biliary forceps biopsies, when used in conjunction with cytology, FISH and DNA analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with bile duct strictures | – | Other: brushing of bile duct strictures for cytology |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 undergoing ERCP for the diagnosis and treatment of bile duct stricture
Key inclusion criteria (3 listed)
- Patients age: > 18 years
- Presence of a biliary stricture
- Ability to provide written informed consent.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brushing of bile duct strictures for cytology | Other | Patients with bile duct strictures |
Primary outcome
• 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
3 secondary outcomes
• 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bile Duct Stricture and Cholangiocarcinoma, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.