Biliary CannulationNCT03413111
Modified Double Wire Technique to Facilitate the Successful Cannulation
A study testing Modified double wire technique in people with Biliary Cannulation and Endoscopic Retrograde Cholangiopancreatography, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
Selective cannulation is considered the most challenging step for most of Endoscopic retrograde cholangiopancreatography (ERCP). Wire-guided cannulation is the standard technique for initial cannulation. When meeting difficulty, double wire technique (DWT) is widely used. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Biliary Cannulation, Endoscopic Retrograde Cholangiopancreatography
- What is being tested?
- Modified double wire technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2018to 16 Feb 2019
- 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
- Patients aged 18-90 with native papilla;
- CBD as the targeted duct;
- Inadvertent PD cannulation more than twice;
- Selective biliary cannulation was not possible within 10 minutes or 5 attempts.
Who cannot join
- Contraindications of ERCP;
- Major or minor PD as the targeted duct;
- NK or transpancreatic precut before enrollment ;
- Surgically altered GI anatomy;
- Papillary carcinoma or stone impaction within papilla or fistula in papilla;
- Prior endoscopic sphincterotomy;
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- Complete pancreas divisum;
- failure of pancreatic duct cannulation;
- Pregnant or breastfeeding women;
- Unwilling or inability to provide consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
Yanglin Pan, M.D., 86-29-84771536, panyanglin@gmail.com
Yanglin Pan, M.D.
About this study
Official title: Modified Double Wire Technique to Facilitate the Successful Cannulation: Prospective Randomized Study
Selective cannulation is considered the most challenging step for most of Endoscopic retrograde cholangiopancreatography (ERCP). Wire-guided cannulation is the standard technique for initial cannulation. When meeting difficulty, double wire technique (DWT) is widely used. With one guidewire occupying pancreatic duct (PD), the following cannulation of common bile duct (CBD) with a sphincterotome preloaded with another guidewire often becomes feasible. However, because of the small opening of the papilla, sometimes it is technically challenging for the following cannulation of CBD with the sphincterotome and PD guidewire in the same working channel. We hypothesized that a tiny cut of the opening of papilla, without the injury of pancreatic sphincter, may facilitate the success of DWT and shorten the overall cannulation time.
- Being tested
- Modified double wire technique
- Keywords
- ERCP, double guidewire technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified double wire techniqueProcedure or surgery
For experimental arm, a tiny cut of papilla orifice, with the length of 5mm, was performed by sphincterotome before the double wire cannulation.
| Study group | Role | What they receive |
|---|---|---|
| Modified double wire technique | Experimental | A sphincterotome was used for standard wire-guided cannulation. If the difficult biliary cannulation occurred and guidewire inadvertently entered PD, a tiny cut of opening, with the length of 5mm, was performed with the sphincterotome. Then the guidewire was left in PD and the sphincterotome withdrew. The same sphincterotome was re-inserted in the working channel alongside the first guidewire, another wire is used for wire-guided selective cannulation of CBD. If the cannulation of CBD was not successful within 5 attempts, other cannulation techniques (e.g. transpancreatic precut, needle knife (NK) precut or over-the stent precut) would be tried at the discretion of endoscopists. A 5Fr, unflanged PD stent was placed before the ending of ERCP. Receives: Procedure: Modified double wire technique |
| Standard double wire technique | No intervention | A sphincterotome was used for standard wire-guided cannulation. If the difficult biliary cannulation occurred and guidewire inadvertently entered PD, the guidewire was left in PD and the sphincterotome withdrew. The same sphincterotome was re-inserted in the working channel alongside the first guidewire, another wire is used for wire-guided selective cannulation of CBD. If the cannulation of CBD was not successful within 5 attempts, other cannulation techniques (e.g. transpancreatic precut, NK precut or over-the stent precut) would be tried at the discretion of endoscopists. A 5Fr, unflanged PD stent was placed before the ending of ERCP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of double wire technique
the rate of successful cannulation of CBD for ≤5 attempts by using the sphincterotome alongside the PD guidewire.
Measured: 3 hours
Secondary outcomes (4)
cannulation time of double wire technique
the time taken from the touching of papilla by the sphincterotome alongside the PD guidewire to the successful cannulation of CBD
Measured: 3 hours
Number of attempts for the successful CBD cannulation
Measured: 3 hours
Overall cannulation success rate
Measured: 3 hours
complication rates
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start2 Feb 2018
- Primary completion16 Jan 2019 (estimated)
- Study completion16 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary CannulationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413111
- Sponsor's protocol ID
- KY20180081-1
- Status last verified
- Feb 2018
- First submitted
- 17 Jan 2018
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Double Wire Technique to Facilitate the Successful Cannulation: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03413111
- Acronym / sponsor ID
- KY20180081-1
- Keywords
- ERCP, double guidewire technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 16 Jan 2019 (estimated)
- Study completion
- 16 Feb 2019 (estimated)
- First posted
- 29 Jan 2018 (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.
Selective cannulation is considered the most challenging step for most of Endoscopic retrograde cholangiopancreatography (ERCP). Wire-guided cannulation is the standard technique for initial cannulation. When meeting difficulty, double wire technique (DWT) is widely used. With one guidewire occupying pancreatic duct (PD), the following cannulation of common bile duct (CBD) with a sphincterotome preloaded with another guidewire often becomes feasible. However, because of the small opening of the papilla, sometimes it is technically challenging for the following cannulation of CBD with the sphincterotome and PD guidewire in the same working channel. We hypothesized that a tiny cut of the opening of papilla, without the injury of pancreatic sphincter, may facilitate the success of DWT and shorten the overall cannulation time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified double wire technique | Experimental | Procedure: Modified double wire techniqueA sphincterotome was used for standard wire-guided cannulation. If the difficult biliary cannulation occurred and guidewire inadvertently entered PD, a tiny cut of opening, with the length of 5mm, was performed with the sphincterotome. Then the guidewire was left in PD and the sphincterotome withdrew. The same sphincterotome was re-inserted in the working channel alongside the first guidewire, another wire is used for wire-guided selective cannulation of CBD. If the cannulation of CBD was not successful within 5 attempts, other cannulation techniques (e.g. transpancreatic precut, needle knife (NK) precut or over-the stent precut) would be tried at the discretion of endoscopists. A 5Fr, unflanged PD stent was placed before the ending of ERCP. |
| Standard double wire technique | No intervention | –A sphincterotome was used for standard wire-guided cannulation. If the difficult biliary cannulation occurred and guidewire inadvertently entered PD, the guidewire was left in PD and the sphincterotome withdrew. The same sphincterotome was re-inserted in the working channel alongside the first guidewire, another wire is used for wire-guided selective cannulation of CBD. If the cannulation of CBD was not successful within 5 attempts, other cannulation techniques (e.g. transpancreatic precut, NK precut or over-the stent precut) would be tried at the discretion of endoscopists. A 5Fr, unflanged PD stent was placed before the ending of ERCP. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-90 with native papilla;
- CBD as the targeted duct;
- Inadvertent PD cannulation more than twice;
- Selective biliary cannulation was not possible within 10 minutes or 5 attempts.
Key exclusion criteria (10 listed)
- Contraindications of ERCP;
- Major or minor PD as the targeted duct;
- NK or transpancreatic precut before enrollment ;
- Surgically altered GI anatomy;
- Papillary carcinoma or stone impaction within papilla or fistula in papilla;
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 |
|---|---|---|
| Modified double wire techniqueFor experimental arm, a tiny cut of papilla orifice, with the length of 5mm, was performed by sphincterotome before the double wire cannulation. | Procedure or surgery | Modified double wire technique |
Primary outcome
Success rate of double wire technique
Time frame: 3 hours
the rate of successful cannulation of CBD for ≤5 attempts by using the sphincterotome alongside the PD guidewire.
4 secondary outcomes
cannulation time of double wire technique
Time frame: 3 hours
Number of attempts for the successful CBD cannulation
Time frame: 3 hours
Overall cannulation success rate
Time frame: 3 hours
complication rates
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified double wire technique in people with Biliary Cannulation and Endoscopic Retrograde Cholangiopancreatography, run by Air Force Military Medical University, China 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 17 May 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pan Yanglin, M.D. (+8613201851680, panyanglin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of double wire technique (time frame: 3 hours). 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 17 May 2018.