Endoscopic Retrograde Cholangiopancreatography (ERCP)NCT06612931
Comparison of Dual-lumen Catheter-guided Mini-forceps Biopsy and Brush Cytology with Vacuum Aspiration in Suspicious Biliary Strictures
A study testing Dual-lumen catheter-guided mini-forceps biopsy is performed first and Biliary brush cytology with vacuum aspiration is performed first in people with Endoscopic Retrograde Cholangiopancreatography (ERCP) and Miniforceps Biopsy, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
In this randomized crossover trial involving patients with indeterminate biliary strictures, we aimed to compare the diagnostic performance of the dual-lumen catheter-guided miniforceps biopsy (CMB) device with that of brush cytology under aspiration (BCA). Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Endoscopic Retrograde Cholangiopancreatography (ERCP), Miniforceps Biopsy, Biliary Strictures
- What is being tested?
- Dual-lumen catheter-guided mini-forceps biopsy is performed first and Biliary brush cytology with vacuum aspiration is performed first
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 16 Aug 2024
- 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 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18-88 years old.
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
- Biliary obstructive symptoms,or indeterminate biliary stricture suspected to be intrinsic based on prior imaging.
Who cannot join
- Any contraindications to ERCP.
- Severe cardiopulmonary disease or coagulopathy.
- Biliary strictures caused by extrinsic compression.
- Unwillingness or inability to provide consent.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China, 201620
About this study
Official title: Comparison of Dual-lumen Catheter-guided Mini-forceps Biopsy and Brush Cytology with Vacuum Aspiration in Suspicious Biliary Strictures: a Multicenter, Randomized, Crossover Trial
In this randomized crossover trial involving patients with indeterminate biliary strictures, we aimed to compare the diagnostic performance of the dual-lumen catheter-guided miniforceps biopsy (CMB) device with that of brush cytology under aspiration (BCA).
- Conditions
- Endoscopic Retrograde Cholangiopancreatography (ERCP), Miniforceps Biopsy, Biliary Strictures, Brush Cytology
- Being tested
- Dual-lumen catheter-guided mini-forceps biopsy is performed first, Biliary brush cytology with vacuum aspiration is performed first
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-lumen catheter-guided mini-forceps biopsy is performed firstProcedure or surgery
In ERCP procedures, catheter-guided mini-forceps biopsy is performed before biliary brush cytology.
Biliary brush cytology with vacuum aspiration is performed firstProcedure or surgery
In ERCP procedures, biliary brush cytology with vacuum aspiration is performed before dilation catheter-guided mini-forceps biopsy.
| Study group | Role | What they receive |
|---|---|---|
| CMB | Experimental | In ERCP procedures, catheter-guided mini-forceps biopsy (CMB) is performed before biliary brush cytology with vacuum aspiration (BCA). Receives: Procedure: Dual-lumen catheter-guided mini-forceps biopsy is performed first |
| BCA | Active comparator | In ERCP procedures, biliary brush cytology with vacuum aspiration (BCA) is performed before dilation catheter-guided mini-forceps biopsy (CMB). Receives: Procedure: Biliary brush cytology with vacuum aspiration is performed first |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic accuracy
The accuracy of dual-lumen catheter-guided miniforceps biopsy (CMB) and brush cytology with vacuum aspiration (BCA) in the diagnosis of biliary strictures.
Measured: 6 months
Secondary outcomes (3)
the diagnostic sensitivity
The diagnostic sensitivity of dual-lumen catheter-guided mini-forceps biopsy and brush cytology with vacuum aspiration to the suspicious biliary strictures.
Measured: 6 months
The diagnostic specificity
The diagnostic specificity of dual-lumen catheter-guided mini-forceps biopsy and brush cytology with vacuum aspiration to the suspicious biliary strictures.
Measured: 6 months
Severe adverse events rates
The incidence of adverse events, namely, post-ERCP pancreatitis, gastrointestinal perforation, and bleeding were compared.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Apr 2023
- Primary completion20 Jul 2024
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Retrograde Cholangiopancreatography (ERCP)Studies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xijing Hospital of Digestive Diseases, Eastern Hepatobiliary Surgery Hospital
- Responsible party
- Principal investigator, Baiwen Li, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Baiwen Li, Ph.D., Principal investigator, Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612931
- Sponsor's protocol ID
- 2022108
- Status last verified
- Aug 2024
- First submitted
- 23 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dual-lumen Catheter-guided Mini-forceps Biopsy and Brush Cytology with Vacuum Aspiration in Suspicious Biliary Strictures: a Multicenter, Randomized, Crossover Trial
- ClinicalTrials.gov ID
- NCT06612931
- Acronym / sponsor ID
- 2022108
- Conditions
- Endoscopic Retrograde Cholangiopancreatography (ERCP), Miniforceps Biopsy, Biliary Strictures, Brush Cytology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Xijing Hospital of Digestive Diseases, Eastern Hepatobiliary Surgery Hospital
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 25 Sep 2024 (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.
In this randomized crossover trial involving patients with indeterminate biliary strictures, we aimed to compare the diagnostic performance of the dual-lumen catheter-guided miniforceps biopsy (CMB) device with that of brush cytology under aspiration (BCA).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMB | Experimental | Procedure: Dual-lumen catheter-guided mini-forceps biopsy is performed firstIn ERCP procedures, catheter-guided mini-forceps biopsy (CMB) is performed before biliary brush cytology with vacuum aspiration (BCA). |
| BCA | Active comparator | Procedure: Biliary brush cytology with vacuum aspiration is performed firstIn ERCP procedures, biliary brush cytology with vacuum aspiration (BCA) is performed before dilation catheter-guided mini-forceps biopsy (CMB). |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18-88 years old.
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
- Biliary obstructive symptoms,or indeterminate biliary stricture suspected to be intrinsic based on prior imaging.
Key exclusion criteria (5 listed)
- Any contraindications to ERCP.
- Severe cardiopulmonary disease or coagulopathy.
- Biliary strictures caused by extrinsic compression.
- Unwillingness or inability to provide consent.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Dual-lumen catheter-guided mini-forceps biopsy is performed firstIn ERCP procedures, catheter-guided mini-forceps biopsy is performed before biliary brush cytology. | Procedure or surgery | CMB |
| Biliary brush cytology with vacuum aspiration is performed firstIn ERCP procedures, biliary brush cytology with vacuum aspiration is performed before dilation catheter-guided mini-forceps biopsy. | Procedure or surgery | BCA |
Primary outcome
The diagnostic accuracy
Time frame: 6 months
The accuracy of dual-lumen catheter-guided miniforceps biopsy (CMB) and brush cytology with vacuum aspiration (BCA) in the diagnosis of biliary strictures.
3 secondary outcomes
the diagnostic sensitivity
Time frame: 6 months
The diagnostic specificity
Time frame: 6 months
Severe adverse events rates
Time frame: 6 months
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 25 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Baiwen Li, Ph.D. principal investigator
Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-lumen catheter-guided mini-forceps biopsy is performed first and Biliary brush cytology with vacuum aspiration is performed first in people with Endoscopic Retrograde Cholangiopancreatography (ERCP) and Miniforceps Biopsy, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 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: finished, as of the sponsor's last update on 25 Sep 2024. 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 China. 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?
The diagnostic accuracy (time frame: 6 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 25 Sep 2024.