Biliary StrictureNCT04010734
Primary Cholangioscopy Versus ERCP in the Diagnosis of Biliary Strictures
A study testing Peroral Cholangioscopy and Endoscopic retrograde cholangiopancreatography 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 and modalities which exist today, there is still a large number of biliary stenosis misdiagnosed with a profound negative impact on the… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Biliary Stricture
- What is being tested?
- Peroral Cholangioscopy and Endoscopic retrograde cholangiopancreatography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCzechia
- Study dates
- 6 May 2019to 7 Jun 2022
- 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 95 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.
Czechia1 site, 1 recruiting
- Recruiting
2nd Department of Internal Medicine, University Hospital and Palacký University, Olomouc, Czech Republic
Olomouc, Olomouc, 771 00
Urban Urban, 00420588443255, ondrej.urban@fnol.cz
About this study
Official title: Primary Peroral Cholangioscopy Versus Endoscopic Retrograde Cholangiopancreatography (With Conventional Sampling - Brushing and Forceps Biopsy- Completed by Fluorescence In Situ Hybridization) in the Diagnosis of Biliary Strictures
The management of biliary strictures depends on their correct pre-operative evaluation which remains challenging. Despite the emerging multitudes of new diagnostic opportunities and modalities which exist today, there is still a large number of biliary stenosis misdiagnosed with a profound negative impact on the patients´ outcome. The study´s aim is to compare the diagnostic yield of primary peroral cholangioscopy and ERCP (with conventional sampling - brushing and forceps biopsy - completed with the FISH) in patients with suspected malignant stricture of the common bile duct and to evaluate the impact of both methods on the management of patients with biliary stricture.
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 and modalities (laboratory, radiological, endoscopic, histopathologic and immunohistological) which exist today, 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. Therefore, diagnostic methods which can maximize the chance of the preoperative diagnosis of indeterminate biliary strictures are needed.
This study will:
compare two methods helping in the diagnosis of suspected malignant biliary stricture-SMBS evaluate the impact of both methods on the management of patients with biliary strictures.
- ERCP (Endoscopic retrograde cholangiopancreatography) is the most widely used diagnostic procedure in patients with biliary obstruction. It enables to identify the biliary stricture, to determinate its location and help providing tissue sampling from the stricture for cytological evaluation. Different methods were used to take samples from the site of the stenosis. Brush-cytology and endocanal forceps biopsies were the most used techniques, both with differents specificity a sensitivity. It was demonstrated by different studies, that Fluorescence in Situ Hybridization (FISH) improved the diagnostic yield of routine cytology. That is the reason why the investigators are going to combine FISH with the conventional sampling methods to maximize the chance to determine the etiology of stenosis early and avoid wasting time.
- The peroral cholangioscopy (DSOC), one of a newer method of endocanal exploration via ERCP- commonly known as the SpyGlass - helps to provide the visual diagnostics of the strictures based on morphological and vascular patterns and to provide directed intraductal biopsy (SpyBite) from the lesions. The combination of both methods should increase the diagnostic yield in the evaluation of indeterminate biliary stricture by DSOC. Because of its high costs, the DSOC is mostly provided later, that is when the ERCP cytology failed (secondary DSOC). This wasted time can be important and determinable for the patients´ outcome. So primary cholangioscopy could help in the correct management of patients with indeterminate biliary stricture, without wasting time.
The study will compare the primary DSOC to ERCP. Success (positivity) is defined by the presence of benign or malignant cells, adequate to make the final tissue diagnosis. Another examination should be performed in situations where the initial method failed.
Gold standard for final diagnosis should be the histology from surgery resection. In patients without surgery, clinical evaluation and cross-over methods are used for comparison of initial methods.
- Conditions
- Biliary Stricture
- Being tested
- Peroral Cholangioscopy and Endoscopic retrograde cholangiopancreatography
- Keywords
- suspected malignant biliary stricture, primary peroral cholangiscopy, endoscopic retrograde cholangiopancreatography, fluorescence in situ hybridization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peroral Cholangioscopy and Endoscopic retrograde cholangiopancreatographyProcedure or surgery
The peroral cholangioscopy (DSOC), one of a newer method of endocanal exploration via ERCP- commonly known as the SpyGlass - helps to provide the visual diagnostics of the strictures based on morphological and vascular patterns and to provide directed intraductal biopsy (SpyBite) from the lesions. The combination of both should increase the diagnostic yield in the evaluation of indeterminate biliary stricture by DSOC.
ERCP is the most widely used diagnostic procedure in patients with biliary obstruction. It enables to identify the biliary stricture, to determinate its location and help providing tissue sampling from the stricture for cytological evaluation. Different methods were used to take samples from the site of the stenosis. Brushing and endocanal forceps biopsies were the most used techniques. The samples from these two techniques will be additionaly examinated using Fluorescence in Situ Hybridization (FISH).
| Study group | Role | What they receive |
|---|---|---|
| peroral Cholangioscopy examination | Active comparator | Patient with suspected malignant biliary stricture (SMBS) is allowed:
to the peroral Cholangioscopy examination with both visual and tissue diagnosis. The visual diagnosis is based on morphological and vascular patterns (presence or not of nodular or papilary masses, irregularity of the surface, morphology of the vessels and the fragility of mucosa). The tissue diagnosis consists on cytopathological evaluation after tissue sampling using minuature biopsy forceps (SpyBite). During this, 5-8 samples are taken under visual control, from different parts of the lesion. Receives: Procedure: Peroral Cholangioscopy and Endoscopic retrograde cholangiopancreatography |
| ERCP examination with sampling | Active comparator | Patient with suspected malignant biliary stricture (SMBS) is allowed:
to ERCP examination with both sampling by brushing and forceps biopsy, with subsequent pathological evaluation and an additional fluorescence in situ hybridization(FISH) examination of the specimens.
ERCP (Endoscopic retrograde cholangiopancreatography) is the most widely used diagnostic procedure in patients with biliary obstruction. It enables to identify the biliary stricture, to determinate its location and help providing tissue sampling from the stricture for cytological evaluation. Brushing and endocanal forceps biopsies were the most used techniques, both with different specificity and sensitivity. It was demonstrated that Fluorescence in Situ Hybridization (FISH) improved the diagnostic yield of routine cytology. That is the reason why the investigators will combine FISH with the sampling methods to maximize the chance to make early diagnosis of the biliary stenosis. Receives: Procedure: Peroral Cholangioscopy and Endoscopic retrograde cholangiopancreatography |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the diagnostic yield of the primary peroral cholangioscopy and the ERCP in patients with suspected malignant biliary stricture - SMBS
The the sensitivity (%) and specificity (%) of primary Peroral Cholangioscopy and ERCP(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 of primary SpyGlass around 92% and of the second method around 75% in the study population (the samples size 66).
Measured: 1-7 days
evaluate the impact of both methods 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 in each group.
Measured: 3-6 months
evaluate the cost-effectiveness of both methods on management of patients with biliary stricture.
The ratio cost (USD)/diagnostic yield(%) of both methods is evaluated and compared.
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 posted8 Jul 2019
- Study start6 May 2019
- Primary completion20 Dec 2021 (estimated)
- Study completion7 Jun 2022 (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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 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
- Ondrej Urban, MD,pHD, Study chair, 2nd Department of Internal Medicine, University Hospital Olomouc, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010734
- Sponsor's protocol ID
- UHO001
- Status last verified
- Jun 2019
- First submitted
- 1 Jun 2019
- Last updated
- 8 Jul 2019
- Results posted
- No
- 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 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Peroral Cholangioscopy Versus Endoscopic Retrograde Cholangiopancreatography (With Conventional Sampling - Brushing and Forceps Biopsy- Completed by Fluorescence In Situ Hybridization) in the Diagnosis of Biliary Strictures
- ClinicalTrials.gov ID
- NCT04010734
- Acronym / sponsor ID
- UHO001
- Conditions
- Biliary Stricture
- Keywords
- suspected malignant biliary stricture, primary peroral cholangiscopy, endoscopic retrograde cholangiopancreatography, fluorescence in situ hybridization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 7 Jun 2022 (estimated)
- First posted
- 8 Jul 2019 (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 and modalities which exist today, there is still a large number of biliary stenosis misdiagnosed with a profound negative impact on the patients´ outcome. The study´s aim is to compare the diagnostic yield of primary peroral cholangioscopy and ERCP (with conventional sampling - brushing and forceps biopsy - completed with the FISH) in patients with suspected malignant stricture of the common bile duct and to evaluate the impact of both methods on the management of patients with biliary stricture.
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 and modalities (laboratory, radiological, endoscopic, histopathologic and immunohistological) which exist today, 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. Therefore, diagnostic methods which can maximize the chance of the preoperative diagnosis of indeterminate biliary strictures are needed.
This study will:
compare two methods helping in the diagnosis of suspected malignant biliary stricture-SMBS evaluate the impact of both methods on the management of patients with biliary strictures.
- ERCP (Endoscopic retrograde cholangiopancreatography) is the most widely used diagnostic procedure in patients with biliary obstruction. It enables to identify the biliary stricture, to determinate its location and help providing tissue sampling from the stricture for cytological evaluation. Different methods were used to take samples from the site of the stenosis. Brush-cytology and endocanal forceps biopsies were the most used techniques, both with differents specificity a sensitivity. It was demonstrated by different studies, that Fluorescence in Situ Hybridization (FISH) improved the diagnostic yield of routine cytology. That is the reason why the investigators are going to combine FISH with the conventional sampling methods to maximize the chance to determine the etiology of stenosis early and avoid wasting time.
- The peroral cholangioscopy (DSOC), one of a newer method of endocanal exploration via ERCP- commonly known as the SpyGlass - helps to provide the visual diagnostics of the strictures based on morphological and vascular patterns and to provide directed intraductal biopsy (SpyBite) from the lesions. The combination of both methods should increase the diagnostic yield in the evaluation of indeterminate biliary stricture by DSOC. Because of its high costs, the DSOC is mostly provided later, that is when the ERCP cytology failed (secondary DSOC). This wasted time can be important and determinable for the patients´ outcome. So primary cholangioscopy could help in the correct management of patients with indeterminate biliary stricture, without wasting time.
The study will compare the primary DSOC to ERCP. Success (positivity) is defined by the presence of benign or malignant cells, adequate to make the final tissue diagnosis. Another examination should be performed in situations where the initial method failed.
Gold standard for final diagnosis should be the histology from surgery resection. In patients without surgery, clinical evaluation and cross-over methods are used for comparison of initial methods.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| peroral Cholangioscopy examination | Active comparator | Procedure: Peroral Cholangioscopy and Endoscopic retrograde cholangiopancreatographyPatient with suspected malignant biliary stricture (SMBS) is allowed: to the peroral Cholangioscopy examination with both visual and tissue diagnosis. The visual diagnosis is based on morphological and vascular patterns (presence or not of nodular or papilary masses, irregularity of the surface, morphology of the vessels and the fragility of mucosa). The tissue diagnosis consists on cytopathological evaluation after tissue sampling using minuature biopsy forceps (SpyBite). During this, 5-8 samples are taken under visual control, from different parts of the lesion. |
| ERCP examination with sampling | Active comparator | Procedure: Peroral Cholangioscopy and Endoscopic retrograde cholangiopancreatographyPatient with suspected malignant biliary stricture (SMBS) is allowed: to ERCP examination with both sampling by brushing and forceps biopsy, with subsequent pathological evaluation and an additional fluorescence in situ hybridization(FISH) examination of the specimens. ERCP (Endoscopic retrograde cholangiopancreatography) is the most widely used diagnostic procedure in patients with biliary obstruction. It enables to identify the biliary stricture, to determinate its location and help providing tissue sampling from the stricture for cytological evaluation. Brushing and endocanal forceps biopsies were the most used techniques, both with different specificity and sensitivity. It was demonstrated that Fluorescence in Situ Hybridization (FISH) improved the diagnostic yield of routine cytology. That is the reason why the investigators will combine FISH with the sampling methods to maximize the chance to make early diagnosis of the biliary stenosis. |
Who may qualify
- Ages
- 18 to 95 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 (6 listed)
- Intrahepatic biliary strictures
- Duodenal stenosis (endoscopically)
- Age : < 18 years
- Coagulopathy :
- (INR >1,5, Platelets < 100)
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 |
|---|---|---|
| Peroral Cholangioscopy and Endoscopic retrograde cholangiopancreatographyThe peroral cholangioscopy (DSOC), one of a newer method of endocanal exploration via ERCP- commonly known as the SpyGlass - helps to provide the visual diagnostics of the strictures based on morphological and vascular patterns and to provide directed intraductal biopsy (SpyBite) from the lesions. The combination of both should increase the diagnostic yield in the evaluation of indeterminate biliary stricture by DSOC. ERCP is the most widely used diagnostic procedure in patients with biliary obstruction. It enables to identify the biliary stricture, to determinate its location and help providing tissue sampling from the stricture for cytological evaluation. Different methods were used to take samples from the site of the stenosis. Brushing and endocanal forceps biopsies were the most used techniques. The samples from these two techniques will be additionaly examinated using Fluorescence in Situ Hybridization (FISH). | Procedure or surgery | ERCP examination with sampling, peroral Cholangioscopy examination |
Primary outcome
compare the diagnostic yield of the primary peroral cholangioscopy and the ERCP in patients with suspected malignant biliary stricture - SMBS
Time frame: 1-7 days
The the sensitivity (%) and specificity (%) of primary Peroral Cholangioscopy and ERCP(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 of primary SpyGlass around 92% and of the second method around 75% in the study population (the samples size 66).
evaluate the impact of both methods on management of patients with biliary stricture.
Time frame: 3-6 months
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 in each group.
evaluate the cost-effectiveness of both methods on management of patients with biliary stricture.
Time frame: 3-6 months
The ratio cost (USD)/diagnostic yield(%) of both methods is evaluated and compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- 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 study chair
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 Peroral Cholangioscopy and Endoscopic retrograde cholangiopancreatography 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 6 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 8 Jul 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 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, vincent04@post.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the diagnostic yield of the primary peroral cholangioscopy and the ERCP in patients with suspected malignant biliary stricture - SMBS (time frame: 1-7 days). The study lists 3 primary outcomes in all. 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 8 Jul 2019.