Malignant Biliary StenosisNCT04840537
Cholangioscopy or Conventional Techniques for Indeterminate Biliary Stenosis
A study testing endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP in people with Malignant Biliary Stenosis, run by Frederic PRAT, MD, PhD at 1 site in France.
Trial summary
Biliary stenosis not associated with a mass is difficult to diagnose with certainty. The diagnosis is usually based on a first-line cytological study of biliary brushing, which allows a diagnosis in 30 to 50% of cases. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Malignant Biliary Stenosis
- What is being tested?
- endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 26 Dec 2018to 26 Dec 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of intra- or extrahepatic biliary stenosis, involving the main bile ducts: common hepatic duct, right and left hepatic ducts
- Presence of clinical jaundice and / or biological cholestasis (GGT> 3N)
- Absence of visible mass near the biliary stenosis after initial morphological assessment by abdominal CT scan, MRI with biliary sequences.
- Endoscopic ultrasound performed and not having allowed the acquisition of material of diagnostic interest by guided puncture of the lesion.
- No history of ERCP in the 6 months preceding inclusion and no biliary prosthesis (plastic or metal) in place at the time of inclusion
- Collegial validation of the need for a formal diagnosis of indeterminate biliary stenosis in order to guide therapeutic management
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- Patients aged 18 to 85
- Patient who gave his consent to participate in the study
- No contraindication to anesthesia (ASA 1, 2,3)
- Patient affiliated to a social security scheme (beneficiary or beneficiary)
- Absence of pregnancy and current contraception in women of childbearing age
Who cannot join
- Presence of a manifest tissue mass in relation to the biliary stenosis on CT and / or MRI imaging.
- Very strong presumption of the etiological diagnosis of biliary stenosis given the history (history, background): i.e. liver surgery, cholecystectomy, autoimmunity
- History of ERCP and / or percutaneous biliary drainage in the 6 months preceding inclusion
- Presence of a plastic or metal biliary prosthesis in place at the time of inclusion
- History of cephalic duodeno-pancreatectomy or hepatico-jejunal anastomosis
- Non-passable stenosis of the main bile duct
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- Severe coagulopathy, thrombocytopenia <75,000 G / L, treatment with clopidogrel cannot be interrupted even temporarily
- Anesthetic contraindication (ASA 4)
- Inability to obtain informed consent
- person deprived of liberty
Trial locations and contacts
1 site in 1 country.
Diane Lorenzo, MD contact
France1 site, 1 recruiting
- Recruiting
Hôpital Beaujon
Clichy, 92110
frederic prat, MD, PhD, +33 (0)140875663, maximilien.barret@aphp.fr
About this study
Official title: Comparison of Two Diagnostic Strategies in Indeterminate Biliary Stenosis: Exploration by Retrograde Cholangioscopy From the Outset or After Failure of Conventional Techniques
Biliary stenosis not associated with a mass is difficult to diagnose with certainty. The diagnosis is usually based on a first-line cytological study of biliary brushing, which allows a diagnosis in 30 to 50% of cases. In the event of negativity, it is then possible to perform a cholangioscopy in a second step, which allows better sensitivity by performing biopsies. Performing cholangioscopy from the start could potentially save time and avoid disturbances associated with intermediate biliary stenting.
The main objective is to compare two strategies for exploring indeterminate biliary stenosis (1st vs. 2nd line retrograde cholangioscopy) in terms of diagnostic performance. The secondary objectives are to compare the same two strategies in terms of effectiveness, side effects and cost-effectiveness.
The primary outcome measure is the diagnostic yield (performance) of the initial investigation of indeterminate biliary stenosis: cytological brushing followed by cholangioscopy in case of failure (control group) or cholangioscopy from the start (study group).
- Conditions
- Malignant Biliary Stenosis
- Being tested
- endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP
- Keywords
- biliary stenosis, cholangioscopy, cholangiocarcinoma, ERCP
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCPProcedure or surgery
endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure for exploration of an indeterminate biliary stenosis and biliary drainage
| Study group | Role | What they receive |
|---|---|---|
| cytological brushing followed by cholangioscopy in case of failure | Active comparator | Not described Receives: Procedure: endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP |
| cholangioscopy from the start | Experimental | Not described Receives: Procedure: endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield (performance) of the initial investigation of indeterminate biliary stenosis: cytological brushing followed by cholangioscopy in case of failure (control group) or cholangioscopy from the start (study group).
Diagnostic performance is expressed primarily by sensitivity for the diagnosis of malignancy.
Measured: 48 months
Secondary outcomes (3)
Specific rate of diagnosis with cholangioscopy by spyglass used in 1st or 2nd intention
Measured: 48 months
Rate of adverse events related to diagnostic procedures in each of the 2 groups
Measured: 48 months
Comparison of the costs of the 2 diagnostic strategies
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start26 Dec 2018
- Primary completion26 Dec 2018
- Study completion26 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Biliary StenosisStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frederic PRAT, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Frederic PRAT, MD, PhD, Hôpital Cochin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840537
- Sponsor's protocol ID
- SFED 131
- Status last verified
- Apr 2021
- First submitted
- 7 Apr 2021
- Last updated
- 12 Apr 2021
- 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 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Diagnostic Strategies in Indeterminate Biliary Stenosis: Exploration by Retrograde Cholangioscopy From the Outset or After Failure of Conventional Techniques
- ClinicalTrials.gov ID
- NCT04840537
- Acronym / sponsor ID
- SFED 131
- Conditions
- Malignant Biliary Stenosis
- Keywords
- biliary stenosis, cholangioscopy, cholangiocarcinoma, ERCP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Frederic PRAT, MD, PhDUniversity, hospital or other
- Study start
- 26 Dec 2018 (actual)
- Primary completion
- 26 Dec 2018 (actual)
- Study completion
- 26 Dec 2022 (estimated)
- First posted
- 12 Apr 2021 (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.
Biliary stenosis not associated with a mass is difficult to diagnose with certainty. The diagnosis is usually based on a first-line cytological study of biliary brushing, which allows a diagnosis in 30 to 50% of cases. In the event of negativity, it is then possible to perform a cholangioscopy in a second step, which allows better sensitivity by performing biopsies. Performing cholangioscopy from the start could potentially save time and avoid disturbances associated with intermediate biliary stenting.
The main objective is to compare two strategies for exploring indeterminate biliary stenosis (1st vs. 2nd line retrograde cholangioscopy) in terms of diagnostic performance. The secondary objectives are to compare the same two strategies in terms of effectiveness, side effects and cost-effectiveness.
The primary outcome measure is the diagnostic yield (performance) of the initial investigation of indeterminate biliary stenosis: cytological brushing followed by cholangioscopy in case of failure (control group) or cholangioscopy from the start (study group).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cytological brushing followed by cholangioscopy in case of failure | Active comparator | Procedure: endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP |
| cholangioscopy from the start | Experimental | Procedure: endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Presence of intra- or extrahepatic biliary stenosis, involving the main bile ducts: common hepatic duct, right and left hepatic ducts
- Presence of clinical jaundice and / or biological cholestasis (GGT> 3N)
- Absence of visible mass near the biliary stenosis after initial morphological assessment by abdominal CT scan, MRI with biliary sequences.
- Endoscopic ultrasound performed and not having allowed the acquisition of material of diagnostic interest by guided puncture of the lesion.
- No history of ERCP in the 6 months preceding inclusion and no biliary prosthesis (plastic or metal) in place at the time of inclusion
Key exclusion criteria (10 listed)
- Presence of a manifest tissue mass in relation to the biliary stenosis on CT and / or MRI imaging.
- Very strong presumption of the etiological diagnosis of biliary stenosis given the history (history, background): i.e. liver surgery, cholecystectomy, autoimmunity
- History of ERCP and / or percutaneous biliary drainage in the 6 months preceding inclusion
- Presence of a plastic or metal biliary prosthesis in place at the time of inclusion
- History of cephalic duodeno-pancreatectomy or hepatico-jejunal anastomosis
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 |
|---|---|---|
| endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCPendoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure for exploration of an indeterminate biliary stenosis and biliary drainage | Procedure or surgery | cholangioscopy from the start, cytological brushing followed by cholangioscopy in case of failure |
Primary outcome
Diagnostic yield (performance) of the initial investigation of indeterminate biliary stenosis: cytological brushing followed by cholangioscopy in case of failure (control group) or cholangioscopy from the start (study group).
Time frame: 48 months
Diagnostic performance is expressed primarily by sensitivity for the diagnosis of malignancy.
3 secondary outcomes
Specific rate of diagnosis with cholangioscopy by spyglass used in 1st or 2nd intention
Time frame: 48 months
Rate of adverse events related to diagnostic procedures in each of the 2 groups
Time frame: 48 months
Comparison of the costs of the 2 diagnostic strategies
Time frame: 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- 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.
Diane Lorenzo, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP in people with Malignant Biliary Stenosis, run by Frederic PRAT, MD, PhD at 1 site in France.
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 11 inclusion and 10 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 12 Apr 2021. 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 France. 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 Frederic Prat, MD, PhD (+33 (0)140875663, frederic.prat@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (performance) of the initial investigation of indeterminate biliary stenosis: cytological brushing followed by cholangioscopy in case of failure (control group) or cholangioscopy from the start (study group). (time frame: 48 months). 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 12 Apr 2021.