Biliary Obstruction Due to Common Bile Duct StonePhase 1/2NCT06694038
Needle-Knife Fistulotomy Vs. Standard Cannulation Trial
A Phase 1/2 study testing Needle Knife Fistulotomy and standard biliary cannulation in people with Biliary Obstruction Due to Common Bile Duct Stone and Malignant Bile Duct Obstruction, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Needle-knife fistulotomy (NKF) is traditionally used to achieve biliary access when standard cannulation (SC) techniques are unsuccessful. Based on technical factors and the design of prior studies, the literature suggests NKF should be reserved for expert advanced endoscopists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Obstruction Due to Common Bile Duct Stone, Malignant Bile Duct Obstruction
- What is being tested?
- Needle Knife Fistulotomy and standard biliary cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2019to 1 Jul 2021
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Exclusion Criteria: if unable to provide informed consent, pregnant, hemodynamically unstable, with a prior known history of biliary sphincterotomy or ampullectomy
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospial
Philadelphia, Pennsylvania, 19107
About this study
Official title: Comparative Efficacy and Safety of Needle-Knife Fistulotomy Vs. Standard Cannulation in Primary Biliary Access: a Practical Randomized Controlled Trial
Needle-knife fistulotomy (NKF) is traditionally used to achieve biliary access when standard cannulation (SC) techniques are unsuccessful. Based on technical factors and the design of prior studies, the literature suggests NKF should be reserved for expert advanced endoscopists. The aim of this study was to evaluate the efficacy and safety of NKF compared to SC for primary biliary access performed by advanced endoscopists with a range of experience including advanced endoscopy trainees.
- Being tested
- Needle Knife Fistulotomy, standard biliary cannulation
- Keywords
- jaundice, bile duct obstruction, abnormal liver enzymes
- Medical subject headings
- Jaundice, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle Knife FistulotomyProcedure or surgery
Biliary access using needle knife fistulotomy technique
standard biliary cannulationProcedure or surgery
standard biliary cannulation
| Study group | Role | What they receive |
|---|---|---|
| Standard Cannulation | Active comparator | Standard Biliary Cannulation Receives: Procedure: standard biliary cannulation |
| NKF Cannulation | Experimental | Biliary Cannulation using NKF technique Receives: Procedure: Needle Knife Fistulotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
post ERCP pancreatitis
Incidence of post ERCP pancreatitis defined as epigastric abdominal pain with lipase more than three times the upper limit of normal occurring within 48 hours of the procedure
Measured: within 48 hours of the procedure
Secondary outcomes (2)
Bleeding
Significant bleeding was defined as a need for transfusion and/or need for repeat endoscopy for hemostasis
Measured: within 48 hours
Perforation
Perforation, defined by a full thickness defect either seen during endoscopy or on radiological studies post procedure.
Measured: within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start31 Jan 2019
- Primary completion25 Jun 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Obstruction Due to Common Bile Duct StoneStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694038
- Sponsor's protocol ID
- 18D.632
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients were not asked to consent for the data to be shared with other institutions
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy and Safety of Needle-Knife Fistulotomy Vs. Standard Cannulation in Primary Biliary Access: a Practical Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06694038
- Acronym / sponsor ID
- 18D.632
- Keywords
- jaundice, bile duct obstruction, abnormal liver enzymes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 19 Nov 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.
Needle-knife fistulotomy (NKF) is traditionally used to achieve biliary access when standard cannulation (SC) techniques are unsuccessful. Based on technical factors and the design of prior studies, the literature suggests NKF should be reserved for expert advanced endoscopists. The aim of this study was to evaluate the efficacy and safety of NKF compared to SC for primary biliary access performed by advanced endoscopists with a range of experience including advanced endoscopy trainees.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Cannulation | Active comparator | Procedure: standard biliary cannulationStandard Biliary Cannulation |
| NKF Cannulation | Experimental | Procedure: Needle Knife FistulotomyBiliary Cannulation using NKF technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Exclusion Criteria: if unable to provide informed consent, pregnant, hemodynamically unstable, with a prior known history of biliary sphincterotomy or ampullectomy
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Needle Knife FistulotomyBiliary access using needle knife fistulotomy technique | Procedure or surgery | NKF Cannulation |
| standard biliary cannulationstandard biliary cannulation | Procedure or surgery | Standard Cannulation |
Primary outcome
post ERCP pancreatitis
Time frame: within 48 hours of the procedure
Incidence of post ERCP pancreatitis defined as epigastric abdominal pain with lipase more than three times the upper limit of normal occurring within 48 hours of the procedure
2 secondary outcomes
Bleeding
Time frame: within 48 hours
Perforation
Time frame: within 48 hours
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 19 Nov 2024.
- Individual participant dataSharing planned: No. Patients were not asked to consent for the data to be shared with other institutions
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?
A Phase 1/2 study testing Needle Knife Fistulotomy and standard biliary cannulation in people with Biliary Obstruction Due to Common Bile Duct Stone and Malignant Bile Duct Obstruction, run by Thomas Jefferson University 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 2 inclusion and 0 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 19 Nov 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 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
post ERCP pancreatitis (time frame: within 48 hours of the procedure). 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 19 Nov 2024.