Endoscopic Retrograde CholangiopancreatographyNCT02297750
Optimal Timing of Double-Wire Technique For Biliary Cannulation at ERCP
A study testing double-wire technique in patients undergoing ERCP with biliary cannulation and single-wire technique in patients undergoing ERCP with biliary cannulation in people with Endoscopic Retrograde Cholangiopancreatography, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to give doctors who perform Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures a better idea as to the best techniques to use in order to examine the bile duct as quickly and safely as possible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Retrograde Cholangiopancreatography
- What is being tested?
- double-wire technique in patients undergoing ERCP with biliary cannulation and single-wire technique in patients undergoing ERCP with biliary cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing ERCP with primary intent to cannulate the bile duct
- Written informed consent
Who cannot join
- Age < 18 years
- Non-naive papilla (previous sphincterotomy)
- Surgically altered anatomy
- Known/suspected pancreas divisum
- Suspected SOD/biliary manometry
- Prior ERCP/stent within 3 months
- ERCP performed in the Operating Room or at Duke North
- Pregnancy/breast-feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The purpose of this study is to give doctors who perform Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures a better idea as to the best techniques to use in order to examine the bile duct as quickly and safely as possible.
Read the detailed description
Sometimes, in the course of a regular ERCP procedure, techniques used by the doctor to pass a wire into the bile duct can result in the pancreas duct being entered instead. When this happens, the doctor may either remove the wire (known as "single wire" technique) or leave it in and use a second wire ("double wire") to enter the bile duct. This study will try to determine whether the "double wire" technique or the "single wire" technique removing the wire is the safest and most efficient.
- Being tested
- double-wire technique in patients undergoing ERCP with biliary cannulation, single-wire technique in patients undergoing ERCP with biliary cannulation
- Keywords
- The focus of the study is double-wire technique versus single wire technique in patients undergoing ERCP with biliary cannulation as the primary objective.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double-wire technique in patients undergoing ERCP with biliary cannulationProcedure or surgery
single-wire technique in patients undergoing ERCP with biliary cannulationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| single wire technique | Active comparator | single wire technique in patients undergoing ERCP with biliary cannulation Receives: Procedure: single-wire technique in patients undergoing ERCP with biliary cannulation |
| Double wire technique | Active comparator | double-wire technique in patients undergoing ERCP with biliary cannulation Receives: Procedure: double-wire technique in patients undergoing ERCP with biliary cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of biliary cannulation
The primary outcome is incidence of successful deep biliary cannulation within 10 minutes.
Measured: 10 minutes after randomization
Secondary outcomes (3)
Success of biliary cannulation
Number of attempts required for successful biliary cannulation
Measured: 2 days after the procedure
Time to successful biliary cannulation
Measured: 2 days after the procedure
Post-ERCP pancreatitis
Measured: 2 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startAug 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Retrograde CholangiopancreatographyStudies of the same condition, open and under way.
- More trials run by Duke 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahfuzul Haque, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297750
- Sponsor's protocol ID
- Pro00033706
- Status last verified
- Nov 2014
- First submitted
- 19 Nov 2014
- Last updated
- 26 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Timing of Double-Wire Technique For Biliary Cannulation at ERCP
- ClinicalTrials.gov ID
- NCT02297750
- Acronym / sponsor ID
- Pro00033706
- Keywords
- The focus of the study is double-wire technique versus single wire technique in patients undergoing ERCP with biliary cannulation as the primary objective.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Nov 2014 (estimated)
- 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 purpose of this study is to give doctors who perform Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures a better idea as to the best techniques to use in order to examine the bile duct as quickly and safely as possible.
Detailed description
Sometimes, in the course of a regular ERCP procedure, techniques used by the doctor to pass a wire into the bile duct can result in the pancreas duct being entered instead. When this happens, the doctor may either remove the wire (known as "single wire" technique) or leave it in and use a second wire ("double wire") to enter the bile duct. This study will try to determine whether the "double wire" technique or the "single wire" technique removing the wire is the safest and most efficient.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single wire technique | Active comparator | Procedure: single-wire technique in patients undergoing ERCP with biliary cannulationsingle wire technique in patients undergoing ERCP with biliary cannulation |
| Double wire technique | Active comparator | Procedure: double-wire technique in patients undergoing ERCP with biliary cannulationdouble-wire technique in patients undergoing ERCP with biliary cannulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing ERCP with primary intent to cannulate the bile duct
- Written informed consent
Key exclusion criteria (8 listed)
- Age < 18 years
- Non-naive papilla (previous sphincterotomy)
- Surgically altered anatomy
- Known/suspected pancreas divisum
- Suspected SOD/biliary manometry
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 |
|---|---|---|
| double-wire technique in patients undergoing ERCP with biliary cannulation | Procedure or surgery | Double wire technique |
| single-wire technique in patients undergoing ERCP with biliary cannulation | Procedure or surgery | single wire technique |
Primary outcome
Success of biliary cannulation
Time frame: 10 minutes after randomization
The primary outcome is incidence of successful deep biliary cannulation within 10 minutes.
3 secondary outcomes
Success of biliary cannulation
Time frame: 2 days after the procedure
Time to successful biliary cannulation
Time frame: 2 days after the procedure
Post-ERCP pancreatitis
Time frame: 2 days after the procedure
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 26 Oct 2015.
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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.
Mahfuzul Haque, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing double-wire technique in patients undergoing ERCP with biliary cannulation and single-wire technique in patients undergoing ERCP with biliary cannulation in people with Endoscopic Retrograde Cholangiopancreatography, run by Duke 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 8 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 26 Oct 2015. 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.
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?
Success of biliary cannulation (time frame: 10 minutes after randomization). 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 26 Oct 2015.