Endoscopic Retrograde Cholangiopancreatography (ERCP)NCT00919074
Comparison of Double Wire Technique With Pancreatic Duct Stent Placement for Difficult Bile Duct Cannulation
A study testing Pancreatic duct stent and Pancreatic wire placement in people with Endoscopic Retrograde Cholangiopancreatography (ERCP) and Bile Duct Cannulation, run by Washington University School of Medicine at 3 sites in United States.
Trial summary
This research project will compare the use of the double wire technique with the placement of a pancreatic duct (PD) stent to achieve deep biliary cannulation without the use of a precut papillotomy. Currently, the data supporting either of these approaches is limited to the referenced case series. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Endoscopic Retrograde Cholangiopancreatography (ERCP), Bile Duct Cannulation
- What is being tested?
- Pancreatic duct stent and Pancreatic wire placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2008to Dec 2014
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First time ERCP
Who cannot join
- Successful bile duct cannulation within six minutes
- Planned pancreatic duct therapy
- Planned pancreatobiliary manometry
- Prior successful ERCP
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwestern University
Chicago, Illinois, 60611
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Comparison of Double Wire Technique With Pancreatic Duct Stent Placement for Difficult Bile Duct Cannulation: a Randomized Clinical Trial
This research project will compare the use of the double wire technique with the placement of a pancreatic duct (PD) stent to achieve deep biliary cannulation without the use of a precut papillotomy. Currently, the data supporting either of these approaches is limited to the referenced case series. More data on the success and complication rates of these techniques are needed. The investigators believe either of these approaches would be preferred by less experienced endoscopists to precut papillotomy. Consequently, it is important to differentiate these techniques and identify which patients may benefit from one or both.
- Being tested
- Pancreatic duct stent, Pancreatic wire placement
- Keywords
- Patients undergoing endoscopic retrograde cholangiopancreatography for the first time, Particular focus on patients who meet predefined criteria for a difficult bile duct cannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic duct stentProcedure or surgery
Placement of a pancreatic duct stent to facilitate bile duct cannulation
Pancreatic wire placementProcedure or surgery
Placement of a pancreatic wire to facilitate bile duct cannulation
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic duct stent | Active comparator | Placement of a pancreatic duct stent to facilitate bile duct cannulation Receives: Procedure: Pancreatic duct stent |
| Pancreatic wire | Active comparator | Placement of a guidewire into the pancreatic duct to facilitate bile duct cannulation. Receives: Procedure: Pancreatic wire placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannulation success rate
Measured: Cannulation is assessed during the index procedure; procedure-related complications are assessed within one week of the procedure
Secondary outcomes (1)
Complication rate
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startSep 2008
- Primary completionJan 2011
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endoscopic Retrograde Cholangiopancreatography (ERCP)Studies of the same condition, open and under way.
- More trials run by Washington 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, University of Oklahoma
- Responsible party
- Sponsor
- Investigators
- Riad R Azar, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919074
- Sponsor's protocol ID
- 08-0831
- Status last verified
- Dec 2014
- First submitted
- 10 Jun 2009
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cote GA, Mullady DK, Jonnalagadda SS, Keswani RN, Wani SB, Hovis CE, Ammar T, Al-Lehibi A, Edmundowicz SA, Komanduri S, Azar RR. Use of a pancreatic duct stent or guidewire facilitates bile duct access with low rates of precut sphincterotomy: a randomized clinical trial. Dig Dis Sci. 2012 Dec;57(12):3271-8. doi: 10.1007/s10620-012-2269-2. Epub 2012 Jun 26.
PubMed 22732831
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Double Wire Technique With Pancreatic Duct Stent Placement for Difficult Bile Duct Cannulation: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00919074
- Acronym / sponsor ID
- 08-0831
- Keywords
- Patients undergoing endoscopic retrograde cholangiopancreatography for the first time, Particular focus on patients who meet predefined criteria for a difficult bile duct cannulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Northwestern University, University of Oklahoma
- Study start
- Sep 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Jun 2009 (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.
This research project will compare the use of the double wire technique with the placement of a pancreatic duct (PD) stent to achieve deep biliary cannulation without the use of a precut papillotomy. Currently, the data supporting either of these approaches is limited to the referenced case series. More data on the success and complication rates of these techniques are needed. The investigators believe either of these approaches would be preferred by less experienced endoscopists to precut papillotomy. Consequently, it is important to differentiate these techniques and identify which patients may benefit from one or both.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreatic duct stent | Active comparator | Procedure: Pancreatic duct stentPlacement of a pancreatic duct stent to facilitate bile duct cannulation |
| Pancreatic wire | Active comparator | Procedure: Pancreatic wire placementPlacement of a guidewire into the pancreatic duct to facilitate bile duct cannulation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First time ERCP
Key exclusion criteria (4 listed)
- Successful bile duct cannulation within six minutes
- Planned pancreatic duct therapy
- Planned pancreatobiliary manometry
- Prior successful ERCP
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 |
|---|---|---|
| Pancreatic duct stentPlacement of a pancreatic duct stent to facilitate bile duct cannulation | Procedure or surgery | Pancreatic duct stent |
| Pancreatic wire placementPlacement of a pancreatic wire to facilitate bile duct cannulation | Procedure or surgery | Pancreatic wire |
Primary outcome
Cannulation success rate
Time frame: Cannulation is assessed during the index procedure; procedure-related complications are assessed within one week of the procedure
1 secondary outcome
Complication rate
Time frame: One week
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 9 Dec 2014.
- Results publication: PubMed 22732831Cote GA, Mullady DK, Jonnalagadda SS, Keswani RN, Wani SB, Hovis CE, Ammar T, Al-Lehibi A, Edmundowicz SA, Komanduri S, Azar RR. Use of a pancreatic duct stent or guidewire facilitates bile duct access with low rates of precut sphincterotomy: a randomized clinical trial. Dig Dis Sci. 2012 Dec;57(12):3271-8. doi: 10.1007/s10620-012-2269-2. Epub 2012 Jun 26.
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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.
Riad R Azar, MD principal investigator
Washington University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreatic duct stent and Pancreatic wire placement in people with Endoscopic Retrograde Cholangiopancreatography (ERCP) and Bile Duct Cannulation, run by Washington University School of Medicine at 3 sites 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 1 inclusion and 4 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 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Cannulation success rate (time frame: Cannulation is assessed during the index procedure; procedure-related complications are assessed within one week of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00919074, which also lists 1 linked publication.
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 9 Dec 2014.