Biliary CannulationNCT04609917
Difficult Cannulation Criteria in Trainee Involved ERCP Cannulation
An observational study of Biliary Cannulation and Endoscopic Retrograde Cholangiopancreatography, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
Endoscopic Retrograde Cholangiopancreatography (ERCP) is one of the most technically challenging procedures in gastrointestinal endoscopy. Selective deep cannulation is a critical step for the performance of ERCP. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biliary Cannulation, Endoscopic Retrograde Cholangiopancreatography
- What is being tested?
- trainee invlovement
- Type of treatment
- Surgery or procedure
- How many people
- 4,415 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 20 Oct 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with native papilla who underwent ERCP in Xijing Hospital in China
Who may be able to join
- patients with native papilla
Who cannot join
- indications of major or minor pancreatic duct (PD) cannulation; no attempts of cannulation due to inaccessible papilla; cannulation via the papillary fistula; patients with duodenal stenosis or anatomical deformity secondary to prior surgery.
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: Proposal of Difficult Cannulation Criteria in Trainee Involved ERCP Cannulation Procedure
Endoscopic Retrograde Cholangiopancreatography (ERCP) is one of the most technically challenging procedures in gastrointestinal endoscopy. Selective deep cannulation is a critical step for the performance of ERCP. The incidence of difficult cannulation has been reported in many studies, ranging from 10% to 40% in patients with native papilla. Difficult cannulation is an independent risk factor for post-ERCP pancreatitis (PEP).
The definition of difficult cannulation has been proposed by European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Initial cannulation is considered difficult with the presence of one or more of the following: more than 5 min for attempting to cannulate; more than 5 contacts with the papilla; more than 1 unintended pancreatic duct cannulation or opacification. The clear definition of difficult cannulation is important for making decisions during or after ERCP, including determining the appropriate time to transfer to advanced cannulation techniques (e.g. early precut) and whether prophylactic methods should be administrated to reduce the risk of PEP. Although 5-5-1 criteria have been widely used during ERCP practice or in relevant studies, it remains unclear whether the current criteria are suitable for the cannulation procedure with trainee involvement. Because of inexperienced manipulation of the scope and accessories, the involvement of trainees generally increases the overall cannulation time and attempts, which are the two important parameters in the criteria of difficult cannulation. Thus, the investigators hypothesized that the definition of difficult cannulation in trainee-involved cannulation might be different from the traditional 5-5-1 criteria.
- Being tested
- trainee invlovement
- Keywords
- ERCP, Difficult cannulation, Trainee, PEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trainee invlovementProcedure or surgery
Patients underwent selective biliary cannulation with trainee involvement
| Study group | Role | What they receive |
|---|---|---|
| trainee group | Patients with native papilla who underwent selective biliary cannulation with trainee involvement Receives: Procedure: trainee invlovement | |
| non-trainee group | Patients with native papilla who underwent selective biliary cannulation without trainee involvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
rates of difficult cannulation
The proportion of the participants with cannulation-related parameters (cannulation time, cannulation attempts, or inadvertent PD cannulation) above the 75% percentile
Measured: 2 hours
Secondary outcomes (3)
incidences of PEP
Measured: 48 hours
overall adverse events
Measured: 48 hours
the proportion of advanced cannulation methods
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start1 Mar 2020
- Primary completion1 Oct 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 4,415 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
- NCT04609917
- Sponsor's protocol ID
- KY20201021-2
- Status last verified
- Oct 2020
- First submitted
- 23 Oct 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
PubMed 31863440Ismail S, Udd M, Lindstrom O, Rainio M, Halttunen J, Kylanpaa L. Criteria for difficult biliary cannulation: start to count. Eur J Gastroenterol Hepatol. 2019 Oct;31(10):1200-1205. doi: 10.1097/MEG.0000000000001515.
PubMed 31464778Halttunen J, Meisner S, Aabakken L, Arnelo U, Gronroos J, Hauge T, Kleveland PM, Nordblad Schmidt P, Saarela A, Swahn F, Toth E, Mustonen H, Lohr JM. Difficult cannulation as defined by a prospective study of the Scandinavian Association for Digestive Endoscopy (SADE) in 907 ERCPs. Scand J Gastroenterol. 2014 Jun;49(6):752-8. doi: 10.3109/00365521.2014.894120. Epub 2014 Mar 14.
PubMed 24628493
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal of Difficult Cannulation Criteria in Trainee Involved ERCP Cannulation Procedure
- ClinicalTrials.gov ID
- NCT04609917
- Acronym / sponsor ID
- KY20201021-2
- Keywords
- ERCP, Difficult cannulation, Trainee, PEP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,415 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 30 Oct 2020 (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.
Endoscopic Retrograde Cholangiopancreatography (ERCP) is one of the most technically challenging procedures in gastrointestinal endoscopy. Selective deep cannulation is a critical step for the performance of ERCP. The incidence of difficult cannulation has been reported in many studies, ranging from 10% to 40% in patients with native papilla. Difficult cannulation is an independent risk factor for post-ERCP pancreatitis (PEP).
The definition of difficult cannulation has been proposed by European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Initial cannulation is considered difficult with the presence of one or more of the following: more than 5 min for attempting to cannulate; more than 5 contacts with the papilla; more than 1 unintended pancreatic duct cannulation or opacification. The clear definition of difficult cannulation is important for making decisions during or after ERCP, including determining the appropriate time to transfer to advanced cannulation techniques (e.g. early precut) and whether prophylactic methods should be administrated to reduce the risk of PEP. Although 5-5-1 criteria have been widely used during ERCP practice or in relevant studies, it remains unclear whether the current criteria are suitable for the cannulation procedure with trainee involvement. Because of inexperienced manipulation of the scope and accessories, the involvement of trainees generally increases the overall cannulation time and attempts, which are the two important parameters in the criteria of difficult cannulation. Thus, the investigators hypothesized that the definition of difficult cannulation in trainee-involved cannulation might be different from the traditional 5-5-1 criteria.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trainee group | – | Procedure: trainee invlovementPatients with native papilla who underwent selective biliary cannulation with trainee involvement |
| non-trainee group | – | –Patients with native papilla who underwent selective biliary cannulation without trainee involvement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with native papilla who underwent ERCP in Xijing Hospital in China
Key inclusion criteria (1 listed)
- patients with native papilla
Key exclusion criteria (1 listed)
- indications of major or minor pancreatic duct (PD) cannulation; no attempts of cannulation due to inaccessible papilla; cannulation via the papillary fistula; patients with duodenal stenosis or anatomical deformity secondary to prior surgery.
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 |
|---|---|---|
| trainee invlovementPatients underwent selective biliary cannulation with trainee involvement | Procedure or surgery | trainee group |
Primary outcome
rates of difficult cannulation
Time frame: 2 hours
The proportion of the participants with cannulation-related parameters (cannulation time, cannulation attempts, or inadvertent PD cannulation) above the 75% percentile
3 secondary outcomes
incidences of PEP
Time frame: 48 hours
overall adverse events
Time frame: 48 hours
the proportion of advanced cannulation methods
Time frame: 4 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 30 Oct 2020.
- Background: PubMed 31863440Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
- Background: PubMed 31464778Ismail S, Udd M, Lindstrom O, Rainio M, Halttunen J, Kylanpaa L. Criteria for difficult biliary cannulation: start to count. Eur J Gastroenterol Hepatol. 2019 Oct;31(10):1200-1205. doi: 10.1097/MEG.0000000000001515.
- Background: PubMed 24628493Halttunen J, Meisner S, Aabakken L, Arnelo U, Gronroos J, Hauge T, Kleveland PM, Nordblad Schmidt P, Saarela A, Swahn F, Toth E, Mustonen H, Lohr JM. Difficult cannulation as defined by a prospective study of the Scandinavian Association for Digestive Endoscopy (SADE) in 907 ERCPs. Scand J Gastroenterol. 2014 Jun;49(6):752-8. doi: 10.3109/00365521.2014.894120. Epub 2014 Mar 14.
Related trials for Biliary Cannulation
Recruiting
Endoscopic Ultrasound-guided Rendezvous Versus Precut Papillotomy
Bile Duct Diseases
Not yet recruitingObservational study
A Convolutional Neural Network for Difficult Biliary Cannulation
Difficult Biliary Cannulation
Not yet recruiting
Pre-cut Versus Intentional Double Guidewire for ERCP Cannulation: Prospective, Randomized Controlled Trial
ERCP, Choledocholithiasis
Recruiting
Efficacy of Fistulotomy for Biliary Cannulation
Cholangiocarcinoma, Choledocholithiasis; Cholangitis
Not yet recruiting
SmartGlass-Guided ERCP with Cannulation of Native Papilla 1.0
Biliary Tract Diseases, Pancreatic Diseases
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?
An observational study of 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 1 inclusion and 1 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 30 Oct 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?
rates of difficult cannulation (time frame: 2 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 NCT04609917, which also lists 3 linked publications.
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 30 Oct 2020.