Cholangiopancreatography, Endoscopic RetrogradeNCT01792466
RCT of the Double Wire Technique for Sphincterotomy
A study testing Transpancreatic sphincterotomy in people with Cholangiopancreatography, Endoscopic Retrograde and Sphincterotomy, Endoscopic, run by Mayo Clinic at 1 site in United States.
Trial summary
Endoscopic cholangiography is a procedure which is performed to image the bile duct and perform therapy like removal of bile duct stones. It is currently standard of care to remove stones from the bile duct when found as they frequently cause complications like infections which can sometime be life threatening. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cholangiopancreatography, Endoscopic Retrograde, Sphincterotomy, Endoscopic, VATER'S AMPULLA
- What is being tested?
- Transpancreatic sphincterotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Nov 2016
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients presenting to Mayo Clinic Arizona for an ERCP who have a native papilla
- Failure to deeply cannulate the CBD in over 5 minutes and with more than 5 attempts
- Stable wire placement into the Pancreatic duct (PD) exclusion criteria
- 1. Any contraindication to undergoing an ERCP. 2. Contraindications to sphincterotomy. 3. Pancreas divisum.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of the Double Wire Technique With or Without Transpancreatic Sphincterotomy for Difficult Common Bile Duct Cannulation
Endoscopic cholangiography is a procedure which is performed to image the bile duct and perform therapy like removal of bile duct stones. It is currently standard of care to remove stones from the bile duct when found as they frequently cause complications like infections which can sometime be life threatening.
Therapy on the biliary tree, like for example stone removal, frequently requires inserting tools through the opening of the duct and cutting of the muscle which control the secretion of juices from the liver. Cutting the muscle helps with securing an easy access to the bile duct. It also helps facilitating dragging the stones out. On certain occasions placing a wire in the bile duct fails and instead the wire keeps entering the pancreatic duct whose opening is adjacent to the bile duct opening. There is evidence to suggest that keeping a wire in the pancreatic duct facilitates placing a second wire in the bile duct possibly because it straightens the duct. On certain occasions this also fails and we resort to cutting the muscle of the pancreas and the bile duct simultaneously to facilitate the access to the bile duct. The more attempt to enter the bile duct the higher the risk of inflammation in the pancreas known as pancreatitis. This makes decreasing the number of attempts at placing the wire in the duct desirable. One way to facilitate placement of the wire in the bile duct is to cut starting from the opening of the pancreas duct aiming toward the bile duct muscle. This often cuts the bile duct sphincter and exposes the bile duct opening. The study is trying to answer if cutting the bile duct sphincter muscle in the direction of the bile duct immediately after a wire has entered the pancreatic duct will make it easier to place the wire in the bile duct as compared to trying to place the wire in the bile duct without cutting the opening. While cutting the muscle canincrease the risk of pancreatitis, repeated attempts at accessing the bile duct can also increase the risk of pancreatitis. So if cutting the pancreatic muscle will facilitate entry to the bile duct and decrease the number of attempts at entering the bile duct then it might be a better way to approach the patient whom we had difficulty in entering the bile duct.
Read the detailed description
This will be a prospective, non blinded randomized controlled trial. We will screen and offer enrollment to all patients presenting to Mayo Clinic Arizona for an ERCP who have a native papilla and an indication for cholangiography and sphincterotomy. Informed consent will be obtained in the preoperative area after obtaining consent for the ERCP. We will randomize all patients in whom we fail to deeply cannulate the CBD using a sphincterotome (Autotome, Boston Scientific) and 0.035" guidewire (0.035" Jagwire or Dreamwire, Boston Scientific) in over 5 minutes or with more than 5 attempts and in whom the wire can be passed in a stable configuration in the Pancreatic duct (PD). We will exclude patients who have any contraindication to undergoing an ERCP, contraindications to sphincterotomy (e,g,, abnormal anatomy, uncorrectable coagulopathy) and those who have pancreas divisum. Patients will be randomized 1:1 using opaque envelopes in blocks of 4 stratified for gender. (Gender stratification is necessary as the risks of ERCP vis pancreatitis are different for males and females). In those randomized to the DWT group, the PD wire will be left in place, the catheter removed and then reinserted next to the PD wire with a second wire to attempt CBD cannluation as previously described (1). In those randomized to TPS, a pancreatic sphincterotomy will be performed with the sphincterotome. The catheter will be removed with the PD wire left in place. The catheter and a second wire will be inserted and CBD cannluation attempted as for the DWT group. All patients will receive a 5Fr pancreatic stent and indomethacin 100 mg rectally to reduce the risk of pancreatitis as per our standard of care (patients with contraindications to NSAIDs (e.g., sensitivity to Indomethacin, aspirin or class, active peptic ulcer disease) will not receive Indomethacin. Patients who fail DWT (at least 10 minutes or 10 further attempts) may be crossed over to TPS at the endoscopist's discretion. Further care the patients receive will be standard of care. We will contact the patients around a months later by telephone to ask about any procedure related complications that were not reported to us.
outcome measures will be assessed on day 1 at the end of the procedure and on day 30.
- Conditions
- Cholangiopancreatography, Endoscopic Retrograde, Sphincterotomy, Endoscopic, VATER'S AMPULLA
- Being tested
- Transpancreatic sphincterotomy
- Keywords
- difficult biliary cannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transpancreatic sphincterotomyProcedure or surgery
A sphinctertome will be placed into the pancreatic duct over a guidewire and the sphincter will be cut in the direction of the bile duct
| Study group | Role | What they receive |
|---|---|---|
| Transpacnreatic sphincterotomy | Experimental | In patients randomized to TPS, a transpancreatic sphincterotomy will be performed with the sphincterotome superficially in the pancreatic duct over a wire. Receives: Procedure: Transpancreatic sphincterotomy |
| Double wire without sphincterotomy | No intervention | In patients randomized to the DWT group, the PD wire will be left in place, the catheter removed and then reinserted next to the PD wire with a second wire to attempt CBD cannluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of attempts needed to achieve deep cannulation with a second wire.
Number of attempts needed to achieve deep cannulation with a second wire.
Measured: Day one
Secondary outcomes (1)
Time from randomization to deep cannulation.
Time from wire stable in the pancreatic duct until the second wire enters the bile duct
Measured: day of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Inadequate recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholangiopancreatography, Endoscopic RetrogradeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas O. Faigel, Mayo Clinic
- Investigators
- Douglas Faigel, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792466
- Sponsor's protocol ID
- 12-007021
- Status last verified
- Jul 2017
- First submitted
- 11 Feb 2013
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Double Wire Technique With or Without Transpancreatic Sphincterotomy for Difficult Common Bile Duct Cannulation
- ClinicalTrials.gov ID
- NCT01792466
- Acronym / sponsor ID
- 12-007021
- Conditions
- Cholangiopancreatography, Endoscopic Retrograde, Sphincterotomy, Endoscopic, VATER'S AMPULLA
- Keywords
- difficult biliary cannulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate recruitment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 15 Feb 2013 (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.
Endoscopic cholangiography is a procedure which is performed to image the bile duct and perform therapy like removal of bile duct stones. It is currently standard of care to remove stones from the bile duct when found as they frequently cause complications like infections which can sometime be life threatening.
Therapy on the biliary tree, like for example stone removal, frequently requires inserting tools through the opening of the duct and cutting of the muscle which control the secretion of juices from the liver. Cutting the muscle helps with securing an easy access to the bile duct. It also helps facilitating dragging the stones out. On certain occasions placing a wire in the bile duct fails and instead the wire keeps entering the pancreatic duct whose opening is adjacent to the bile duct opening. There is evidence to suggest that keeping a wire in the pancreatic duct facilitates placing a second wire in the bile duct possibly because it straightens the duct. On certain occasions this also fails and we resort to cutting the muscle of the pancreas and the bile duct simultaneously to facilitate the access to the bile duct. The more attempt to enter the bile duct the higher the risk of inflammation in the pancreas known as pancreatitis. This makes decreasing the number of attempts at placing the wire in the duct desirable. One way to facilitate placement of the wire in the bile duct is to cut starting from the opening of the pancreas duct aiming toward the bile duct muscle. This often cuts the bile duct sphincter and exposes the bile duct opening. The study is trying to answer if cutting the bile duct sphincter muscle in the direction of the bile duct immediately after a wire has entered the pancreatic duct will make it easier to place the wire in the bile duct as compared to trying to place the wire in the bile duct without cutting the opening. While cutting the muscle canincrease the risk of pancreatitis, repeated attempts at accessing the bile duct can also increase the risk of pancreatitis. So if cutting the pancreatic muscle will facilitate entry to the bile duct and decrease the number of attempts at entering the bile duct then it might be a better way to approach the patient whom we had difficulty in entering the bile duct.
Detailed description
This will be a prospective, non blinded randomized controlled trial. We will screen and offer enrollment to all patients presenting to Mayo Clinic Arizona for an ERCP who have a native papilla and an indication for cholangiography and sphincterotomy. Informed consent will be obtained in the preoperative area after obtaining consent for the ERCP. We will randomize all patients in whom we fail to deeply cannulate the CBD using a sphincterotome (Autotome, Boston Scientific) and 0.035" guidewire (0.035" Jagwire or Dreamwire, Boston Scientific) in over 5 minutes or with more than 5 attempts and in whom the wire can be passed in a stable configuration in the Pancreatic duct (PD). We will exclude patients who have any contraindication to undergoing an ERCP, contraindications to sphincterotomy (e,g,, abnormal anatomy, uncorrectable coagulopathy) and those who have pancreas divisum. Patients will be randomized 1:1 using opaque envelopes in blocks of 4 stratified for gender. (Gender stratification is necessary as the risks of ERCP vis pancreatitis are different for males and females). In those randomized to the DWT group, the PD wire will be left in place, the catheter removed and then reinserted next to the PD wire with a second wire to attempt CBD cannluation as previously described (1). In those randomized to TPS, a pancreatic sphincterotomy will be performed with the sphincterotome. The catheter will be removed with the PD wire left in place. The catheter and a second wire will be inserted and CBD cannluation attempted as for the DWT group. All patients will receive a 5Fr pancreatic stent and indomethacin 100 mg rectally to reduce the risk of pancreatitis as per our standard of care (patients with contraindications to NSAIDs (e.g., sensitivity to Indomethacin, aspirin or class, active peptic ulcer disease) will not receive Indomethacin. Patients who fail DWT (at least 10 minutes or 10 further attempts) may be crossed over to TPS at the endoscopist's discretion. Further care the patients receive will be standard of care. We will contact the patients around a months later by telephone to ask about any procedure related complications that were not reported to us.
outcome measures will be assessed on day 1 at the end of the procedure and on day 30.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transpacnreatic sphincterotomy | Experimental | Procedure: Transpancreatic sphincterotomyIn patients randomized to TPS, a transpancreatic sphincterotomy will be performed with the sphincterotome superficially in the pancreatic duct over a wire. |
| Double wire without sphincterotomy | No intervention | –In patients randomized to the DWT group, the PD wire will be left in place, the catheter removed and then reinserted next to the PD wire with a second wire to attempt CBD cannluation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients presenting to Mayo Clinic Arizona for an ERCP who have a native papilla
- Failure to deeply cannulate the CBD in over 5 minutes and with more than 5 attempts
- Stable wire placement into the Pancreatic duct (PD) exclusion criteria
- 1. Any contraindication to undergoing an ERCP. 2. Contraindications to sphincterotomy. 3. Pancreas divisum.
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 |
|---|---|---|
| Transpancreatic sphincterotomyA sphinctertome will be placed into the pancreatic duct over a guidewire and the sphincter will be cut in the direction of the bile duct | Procedure or surgery | Transpacnreatic sphincterotomy |
Primary outcome
Number of attempts needed to achieve deep cannulation with a second wire.
Time frame: Day one
Number of attempts needed to achieve deep cannulation with a second wire.
1 secondary outcome
Time from randomization to deep cannulation.
Time frame: day of the procedure
Results and safety
The study was stopped early (reason given: Inadequate recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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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.
Douglas Faigel, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transpancreatic sphincterotomy in people with Cholangiopancreatography, Endoscopic Retrograde and Sphincterotomy, Endoscopic, run by Mayo Clinic 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 4 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: stopped early, as of the sponsor's last update on 21 Jul 2017. 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 was stopped early (reason given: Inadequate recruitment). Results are not available in the source record.
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?
Number of attempts needed to achieve deep cannulation with a second wire. (time frame: Day one). 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 21 Jul 2017.