Biliary CannulationNCT03707613
Learning Curve of Double-wire Cannulation Technique During Endoscopic Retrograde Cholangiopancreatography (ERCP)
A study testing DWT learning curve 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 80 years
- Conditions the study is for
- Biliary Cannulation, Endoscopic Retrograde Cholangiopancreatography
- What is being tested?
- DWT learning curve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2018to 29 Sep 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-90 with native papilla
- patients with diffcult cannulation of bile duct
- Inadvertent pancreatic duct cannulation
Who cannot join
- Contraindications of ERCP
- Major or minor pancreatic duct as the targeted duct
- Prior EST or needle-knife precut before DWT
- Surgically altered gastrointestinal anatomy
- Papillary carcinoma or stone impaction within papilla
- Complete pancreas divisum
- Pregnant or breastfeeding women
- Unwilling or inability to provide consent
Trial locations and contacts
1 site in 1 country.
China1 site
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
About this study
Official title: Learning Curve of Double-wire Cannulation Technique During Endoscopic Retrograde Cholangiopancreatography(ERCP): a Pilot 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 CBD with a sphincterome preloaded with another guidewire often becomes feasible.
When performing DWT, a sphincterotome should enter the common duct of papilla through a small orifice and be placed in the left and upper direction of PD guidewire. Then another guidewire can be advanced into bile duct. As an advanced cannulation technique, DWT can be successfully performed in up to 80% of difficult patients. However, it can be technically difficult, especially for trainees or endoscopists without adequate experience.
Here we planned to prospectively record the procedures of double-wire cannulation by two trainees without prior experience of DWT. This study aims to delinate the learning curve of DWT and its safety by trainees.
- Being tested
- DWT learning curve
- Keywords
- ERCP, double guidewire technique, learning curve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWT learning curveProcedure or surgery
trainees learn to perform DWT after unsuccessful initial cannulation
| Study group | Role | What they receive |
|---|---|---|
| DWT learning curve | Experimental | Initial cannulation is performed with a wire-guided sphincterotome by a trainee. If the cannulation proves difficult (cannulation time >10min, cannulation attemtps >5 or inadvertent PD cannulation >1) and PD is inadvertently entered, DWT will be performed by one of the two trainees. If DWT fails within 5min or 5 attempts, a trainer will take over and continue the cannulation. To prevent PEP, all patients receive prophylactic PD stent and post-ERCP rectal indomethacin. Aggressive hydartion will be administrated at the discretion of endoscopists. Receives: Procedure: DWT learning curve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful cannulation of bile duct within 5min or 5 attempts of cannulation
It was defined by assurance of entering bile duct through cholangiogram during fluoroscopy.
Measured: 3 hours
Secondary outcomes (5)
Successful cannulation time with DWT by trainees
Successful cannulation time was defined by the time taken from the begining of DWT to entering bile duct successfully
Measured: 3 hours
Cannulation attempts with DWT by trainees
One cannulation attempt was defined by touching papilla for more than 5 seconds.
Measured: 3 hours
Precut rate
Precut includes the procedure of cannulation involving needle knife or dual knife and transpancreatic precut by a sphincterotome.
Measured: 3 hours
post-ERCP pancreatitis(PEP)
PEP is defined according to Cotton's criteria. The severity classification is based on revised Atlanta criteria.
Measured: 48 hours
Overall ERCP-related complications
Overall ERCP-related complations include PEP, bleeding, perforation, cholangitis and others, which is defined by Cotton's criteria.
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 posted16 Oct 2018
- Study start15 Oct 2018
- Primary completion28 Aug 2019
- Study completion29 Sep 2019
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 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
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
- NCT03707613
- Sponsor's protocol ID
- KY20180081-3
- Status last verified
- Jan 2020
- First submitted
- 12 Oct 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Ren G, Xi Y, Luo H, Liang S, Wang B, Tao Q, Luo B, Qin Q, Farrell JJ, Guo X, Wu K, Pan Y. Learning curve of double-guidewire technique by trainees during hands-on endoscopic retrograde cholangiopancreatography training. J Gastroenterol Hepatol. 2020 Dec;35(12):2176-2183. doi: 10.1111/jgh.15120. Epub 2020 Jun 23.
PubMed 32473040
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Curve of Double-wire Cannulation Technique During Endoscopic Retrograde Cholangiopancreatography(ERCP): a Pilot Study
- ClinicalTrials.gov ID
- NCT03707613
- Acronym / sponsor ID
- KY20180081-3
- Keywords
- ERCP, double guidewire technique, learning curve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 29 Sep 2019 (actual)
- First posted
- 16 Oct 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 CBD with a sphincterome preloaded with another guidewire often becomes feasible.
When performing DWT, a sphincterotome should enter the common duct of papilla through a small orifice and be placed in the left and upper direction of PD guidewire. Then another guidewire can be advanced into bile duct. As an advanced cannulation technique, DWT can be successfully performed in up to 80% of difficult patients. However, it can be technically difficult, especially for trainees or endoscopists without adequate experience.
Here we planned to prospectively record the procedures of double-wire cannulation by two trainees without prior experience of DWT. This study aims to delinate the learning curve of DWT and its safety by trainees.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DWT learning curve | Experimental | Procedure: DWT learning curveInitial cannulation is performed with a wire-guided sphincterotome by a trainee. If the cannulation proves difficult (cannulation time >10min, cannulation attemtps >5 or inadvertent PD cannulation >1) and PD is inadvertently entered, DWT will be performed by one of the two trainees. If DWT fails within 5min or 5 attempts, a trainer will take over and continue the cannulation. To prevent PEP, all patients receive prophylactic PD stent and post-ERCP rectal indomethacin. Aggressive hydartion will be administrated at the discretion of endoscopists. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-90 with native papilla
- patients with diffcult cannulation of bile duct
- Inadvertent pancreatic duct cannulation
Key exclusion criteria (8 listed)
- Contraindications of ERCP
- Major or minor pancreatic duct as the targeted duct
- Prior EST or needle-knife precut before DWT
- Surgically altered gastrointestinal anatomy
- Papillary carcinoma or stone impaction within 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 |
|---|---|---|
| DWT learning curvetrainees learn to perform DWT after unsuccessful initial cannulation | Procedure or surgery | DWT learning curve |
Primary outcome
Successful cannulation of bile duct within 5min or 5 attempts of cannulation
Time frame: 3 hours
It was defined by assurance of entering bile duct through cholangiogram during fluoroscopy.
5 secondary outcomes
Successful cannulation time with DWT by trainees
Time frame: 3 hours
Cannulation attempts with DWT by trainees
Time frame: 3 hours
Precut rate
Time frame: 3 hours
post-ERCP pancreatitis(PEP)
Time frame: 48 hours
Overall ERCP-related complications
Time frame: 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 27 Jan 2020.
- Derived from this study: PubMed 32473040Wang X, Ren G, Xi Y, Luo H, Liang S, Wang B, Tao Q, Luo B, Qin Q, Farrell JJ, Guo X, Wu K, Pan Y. Learning curve of double-guidewire technique by trainees during hands-on endoscopic retrograde cholangiopancreatography training. J Gastroenterol Hepatol. 2020 Dec;35(12):2176-2183. doi: 10.1111/jgh.15120. Epub 2020 Jun 23.
- 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.
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 study testing DWT learning curve 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 3 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 27 Jan 2020. 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?
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?
Successful cannulation of bile duct within 5min or 5 attempts of cannulation (time frame: 3 hours). 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 NCT03707613, 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 27 Jan 2020.