Biliary StrictureNCT04391153
FISH in Diagnosis of Biliary Stricture
A study testing ERCP with tissue sampling in people with Biliary Stricture, run by University Hospital Olomouc at 1 site in Czechia.
Trial summary
The management of biliary strictures depends on their correct pre-operative evaluation which remains challenging. Despite the emerging multitudes of new diagnostic opportunities- modalities we have today, there is still a large number of biliary stenosis misdiagnosed with a profound negative impact on the patients´… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Biliary Stricture
- What is being tested?
- ERCP with tissue sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteCzechia
- Study dates
- 3 May 2020to 19 Dec 2021
- Phase
- Interventional
- 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
Who may be able to join
- Suspected malignant biliary stricture
- Localization: Extrahepatic biliary duct
- Patient´s consent with a diagnostic procedure
- Age : 18 years or more
Who cannot join
- Intrahepatic biliary strictures
- Duodenal stenosis (endoscopically)
- Age : < 18 years
- Coagulopathy : (INR >1,5, Platelets < 100)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Ondrej Urban, MD, PhD contact
Czechia1 site, 1 recruiting
- Recruiting
2nd Department of Internal Medicine, University Hospital and Palacký University,
Olomouc, 771 00
MD, 00420608080209, vincent04@post.cz
Ondrej Urban, MD, PhD, 00420588443255, ondrej.urban@fnol.cz
About this study
Official title: Fluorescent in Situ Hybridization in Diagnosis of Biliary Stricture: A Feasibility Study
The management of biliary strictures depends on their correct pre-operative evaluation which remains challenging. Despite the emerging multitudes of new diagnostic opportunities- modalities we have today, there is still a large number of biliary stenosis misdiagnosed with a profound negative impact on the patients´ outcome. The study aims to proove the feasibility and to evaluate the impact of Fluorescent In Situ Hybridization (FISH) on the tissue diagnostic of biliary strictures.
Read the detailed description
The management of biliary strictures depends on their correct pre-operative evaluation which remains challenging. Biliary strictures have various etiologies (traumatic, inflammatory, tumoral, ischemic etc), which are necessarily needed to be known for the correct therapeutic approach. Despite the emerging multitudes of new diagnostic opportunities, there is still a large number of biliary stenosis misdiagnosed with a profound negative impact on the patients´ outcome. The dilemma that exists is how to balance the risk of missing the chance of curative surgery for some malignancy and preventing some patients from unnecessary surgery for benign etiologies and not to waste time. Different conventionnal sampling methods (as Brush-cytology, forceps biopsies during ERCP, endoscopic guided fine needle aspiration-EUS-FNA) have relatively low sensitivity. In such cases, the peroral cholangioscopy proves diagnostic accuracy of 90 %. This method remains expert dependent, costly and may be result in complications of cholangitis in 3-5 % of cases. Techniques or others methods less complicated and improving the preoperative diagnosis of biliary strictures are needed. Fluorescent in Situ Hybridization (FISH) was shown to improve the diagnostic yield of routine cytology.
This study will proove the feasebility and the clinical place of FISH in the diagnostic of biliary strictures and evaluate the impact of FISH on management of patients with biliary strictures.
FISH (Fluorecent In Situ Hybridization) is a molecular cytogenetic method, which enables the detection of fluorescently- labeled DNA/RNA or oligonucleotide probes hybridized to metaphase/ interphase. It uses probes to bind to specific DNA/RNA sequences. This enables the detection of aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 in patients with suspected malignant biliary strictures.
Different methods were used to take samples from the site of the stenosis. Brush-cytology and endocanal forceps biopsies during ERCP and FNA (fine needle aspiration) during EUS (endosonography). These sampling techniques have relatively low specificity and sensitivity. Reason why we will combine FISH with the sampling methods to maximize our chance to early determine the etiology of stenosis and avoid wasting time and unnecessary cholangioscopy. In this study, the positivity of FISH for Chromosomes 3,7,17 is defined by a presence of polysomy of these chromosomes and the positivity of FISH for Chromosomal region defined by a presence of heterozygous delection or homozygous delection for 9p21. Polysomy is defined by a gain of 2 or more chromosomes in 4 cells. For the chromosomal region, the delection or loss of 9p21 must be observed in 12 cells.
Methods:
- Tissue specimens obtained via either brush cytology, forceps biopsy or fine needle aspiration during ERCP or endosonography (EUS) were examined by routine cytology or histology (RC) methods.
- In addition, FISH using fluorescent-based polynucleotide probes targeting chromosomes 3, 7, 17 and locus 9p21 was performed (ZytoVysion®).
Success (positivity) is defined by the presence of polysomy for chromosomes 3, 7, 17 and/or the presence of delection or loss of the chromosomal region 9p21 in patients with suspected malignant biliary strictures.
Gold standard for final diagnosis should be the histology from surgery resection. In patients without surgery, a follow up of 12 months will be considered adequate to exclude or confirm malignant etiology of the stritures.
- Conditions
- Biliary Stricture
- Being tested
- ERCP with tissue sampling
- Keywords
- suspected malignant biliary stricture, fluorescence in situ hybridization, endoscopic retrograde cholangiopancreatography, brushing, forceps biopsy, endosonography/ EUS-FNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP with tissue samplingProcedure or surgery
Patients with biliary strictures undergo ERCP o EUS. Tissue specimens obtained via either of brush cytology, forceps biopsy or fine needle aspiration during ERCP or endosonography (EUS) were examined by routine cytology or histology methods. In addition, FISH inlcuding fluorescence-based polynucleotide probes targeting chromosomes 3, 7, 17 and locus 9p21 was performed. Gold standard for final diagnosis is the histology from surgical resection. In patients without surgery, a follow up of 12 months will be considered adequate to exclude or confirm malignant etiology.
| Study group | Role | What they receive |
|---|---|---|
| conventional samplig | Active comparator | Patients with biliary strictures udergo ERCP or EUS. Tissue specimens obtained via either of brush cytology, forceps biopsy or fine needle aspiration during ERCP or endosonography (EUS) were examined by routine cytology or histology methods.
Gold standard for final diagnosis is the histology from surgical resection. In patients without surgery, a follow up of 12 months will be considered adequate to exclude or confirm malignant etiology. Receives: Procedure: ERCP with tissue sampling |
| Fluorescence in situ Hybridization (FISH) | Active comparator | Tissue specimens obtained via either of brush cytology, forceps biopsy or fine needle aspiration during ERCP or endosonography (EUS) were examined by routine cytology or histology methods. In addition, FISH inlcuding fluorescence-based polynucleotide probes targeting chromosomes 3, 7, 17 and locus 9p21 was performed. Gold standard for final diagnosis is the histology from surgical resection. In patients without surgery, a follow up of 12 months will be considered adequate to exclude or confirm malignant etiology. Receives: Procedure: ERCP with tissue sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proove the feasebility and the clinical place of FISH in the diagnostic of biliary strictures
The the sensitivity (%) and specificity (%) of ERCP/ EUS with conventional tissue sampling - Brushing, forceps biopsy/EUS-FNA and ERCP/EUS with conventional tissue sampling completed with FISH in patients with suspected malignant stricture of the common bile duct are evaluated. Success (positivity) is defined by the presence of benign or malignant cells, adequate to make the final tissue diagnosis. Based on the previous studies and the experiences of our endoscopists and pathologist, we can expect the diagnostic yield with FISH will be increased of 20-30% in the study population (the samples size 96).
Measured: 1- 7 days
Secondary outcomes (1)
evaluate the impact of FISH on management of patients with biliary stricture.
The proportion of patients (%) who will miss the chance of curative surgery for some malignancy and the proportion of patients (%) who will not have unnecessary surgery for benign etiologies are evaluated.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start3 May 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion19 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary StrictureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincent Zoundjiekpon, University Hospital Olomouc
- Investigators
- Vincent Zoundjiekpon, MD, Principal investigator, 2nd Department of Internal Medicine, University Hospital Olomouc, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391153
- Sponsor's protocol ID
- UHO003
- Status last verified
- May 2020
- First submitted
- 10 May 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescent in Situ Hybridization in Diagnosis of Biliary Stricture: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04391153
- Acronym / sponsor ID
- UHO003
- Conditions
- Biliary Stricture
- Keywords
- suspected malignant biliary stricture, fluorescence in situ hybridization, endoscopic retrograde cholangiopancreatography, brushing, forceps biopsy, endosonography/ EUS-FNA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Study start
- 3 May 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 19 Dec 2021 (estimated)
- First posted
- 18 May 2020 (actual)
- 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 management of biliary strictures depends on their correct pre-operative evaluation which remains challenging. Despite the emerging multitudes of new diagnostic opportunities- modalities we have today, there is still a large number of biliary stenosis misdiagnosed with a profound negative impact on the patients´ outcome. The study aims to proove the feasibility and to evaluate the impact of Fluorescent In Situ Hybridization (FISH) on the tissue diagnostic of biliary strictures.
Detailed description
The management of biliary strictures depends on their correct pre-operative evaluation which remains challenging. Biliary strictures have various etiologies (traumatic, inflammatory, tumoral, ischemic etc), which are necessarily needed to be known for the correct therapeutic approach. Despite the emerging multitudes of new diagnostic opportunities, there is still a large number of biliary stenosis misdiagnosed with a profound negative impact on the patients´ outcome. The dilemma that exists is how to balance the risk of missing the chance of curative surgery for some malignancy and preventing some patients from unnecessary surgery for benign etiologies and not to waste time. Different conventionnal sampling methods (as Brush-cytology, forceps biopsies during ERCP, endoscopic guided fine needle aspiration-EUS-FNA) have relatively low sensitivity. In such cases, the peroral cholangioscopy proves diagnostic accuracy of 90 %. This method remains expert dependent, costly and may be result in complications of cholangitis in 3-5 % of cases. Techniques or others methods less complicated and improving the preoperative diagnosis of biliary strictures are needed. Fluorescent in Situ Hybridization (FISH) was shown to improve the diagnostic yield of routine cytology.
This study will proove the feasebility and the clinical place of FISH in the diagnostic of biliary strictures and evaluate the impact of FISH on management of patients with biliary strictures.
FISH (Fluorecent In Situ Hybridization) is a molecular cytogenetic method, which enables the detection of fluorescently- labeled DNA/RNA or oligonucleotide probes hybridized to metaphase/ interphase. It uses probes to bind to specific DNA/RNA sequences. This enables the detection of aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 in patients with suspected malignant biliary strictures.
Different methods were used to take samples from the site of the stenosis. Brush-cytology and endocanal forceps biopsies during ERCP and FNA (fine needle aspiration) during EUS (endosonography). These sampling techniques have relatively low specificity and sensitivity. Reason why we will combine FISH with the sampling methods to maximize our chance to early determine the etiology of stenosis and avoid wasting time and unnecessary cholangioscopy. In this study, the positivity of FISH for Chromosomes 3,7,17 is defined by a presence of polysomy of these chromosomes and the positivity of FISH for Chromosomal region defined by a presence of heterozygous delection or homozygous delection for 9p21. Polysomy is defined by a gain of 2 or more chromosomes in 4 cells. For the chromosomal region, the delection or loss of 9p21 must be observed in 12 cells.
Methods:
- Tissue specimens obtained via either brush cytology, forceps biopsy or fine needle aspiration during ERCP or endosonography (EUS) were examined by routine cytology or histology (RC) methods.
- In addition, FISH using fluorescent-based polynucleotide probes targeting chromosomes 3, 7, 17 and locus 9p21 was performed (ZytoVysion®).
Success (positivity) is defined by the presence of polysomy for chromosomes 3, 7, 17 and/or the presence of delection or loss of the chromosomal region 9p21 in patients with suspected malignant biliary strictures.
Gold standard for final diagnosis should be the histology from surgery resection. In patients without surgery, a follow up of 12 months will be considered adequate to exclude or confirm malignant etiology of the stritures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional samplig | Active comparator | Procedure: ERCP with tissue samplingPatients with biliary strictures udergo ERCP or EUS. Tissue specimens obtained via either of brush cytology, forceps biopsy or fine needle aspiration during ERCP or endosonography (EUS) were examined by routine cytology or histology methods. Gold standard for final diagnosis is the histology from surgical resection. In patients without surgery, a follow up of 12 months will be considered adequate to exclude or confirm malignant etiology. |
| Fluorescence in situ Hybridization (FISH) | Active comparator | Procedure: ERCP with tissue samplingTissue specimens obtained via either of brush cytology, forceps biopsy or fine needle aspiration during ERCP or endosonography (EUS) were examined by routine cytology or histology methods. In addition, FISH inlcuding fluorescence-based polynucleotide probes targeting chromosomes 3, 7, 17 and locus 9p21 was performed. Gold standard for final diagnosis is the histology from surgical resection. In patients without surgery, a follow up of 12 months will be considered adequate to exclude or confirm malignant etiology. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Suspected malignant biliary stricture
- Localization: Extrahepatic biliary duct
- Patient´s consent with a diagnostic procedure
- Age : 18 years or more
Key exclusion criteria (5 listed)
- Intrahepatic biliary strictures
- Duodenal stenosis (endoscopically)
- Age : < 18 years
- Coagulopathy : (INR >1,5, Platelets < 100)
- Pregnancy
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 |
|---|---|---|
| ERCP with tissue samplingPatients with biliary strictures undergo ERCP o EUS. Tissue specimens obtained via either of brush cytology, forceps biopsy or fine needle aspiration during ERCP or endosonography (EUS) were examined by routine cytology or histology methods. In addition, FISH inlcuding fluorescence-based polynucleotide probes targeting chromosomes 3, 7, 17 and locus 9p21 was performed. Gold standard for final diagnosis is the histology from surgical resection. In patients without surgery, a follow up of 12 months will be considered adequate to exclude or confirm malignant etiology. | Procedure or surgery | Fluorescence in situ Hybridization (FISH), conventional samplig |
Primary outcome
Proove the feasebility and the clinical place of FISH in the diagnostic of biliary strictures
Time frame: 1- 7 days
The the sensitivity (%) and specificity (%) of ERCP/ EUS with conventional tissue sampling - Brushing, forceps biopsy/EUS-FNA and ERCP/EUS with conventional tissue sampling completed with FISH in patients with suspected malignant stricture of the common bile duct are evaluated. Success (positivity) is defined by the presence of benign or malignant cells, adequate to make the final tissue diagnosis. Based on the previous studies and the experiences of our endoscopists and pathologist, we can expect the diagnostic yield with FISH will be increased of 20-30% in the study population (the samples size 96).
1 secondary outcome
evaluate the impact of FISH on management of patients with biliary stricture.
Time frame: 3-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Individual participant dataSharing planned: No
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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.
Ondrej Urban, MD, PhD contact
Vincent Zoundjiekpon, MD principal investigator
2nd Department of Internal Medicine, University Hospital Olomouc, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP with tissue sampling in people with Biliary Stricture, run by University Hospital Olomouc at 1 site in Czechia.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 May 2020. 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 Czechia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent Zoundjiekpon, MD (00420608080209 ext. 001, vincent04@post.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proove the feasebility and the clinical place of FISH in the diagnostic of biliary strictures (time frame: 1- 7 days). 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 20 May 2020.