Prevalence and Predictive Factors of Difficult Biliary Cannulation
ConditionDifficult Biliary Cannulation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of La Laguna
About this trial
The main purpose of the study is to evaluate the prevalence of difficult biliary cannulation using endoscopic retrograde cholangiopancreatography (ERCP) according to the criteria defined by the European Society of Gastrointestinal Endoscopy (ESGE) and the American Society for Gastrointestinal Endoscopy (ASGE), as well as the predictive factors for this event in a prospective, multicenter study. Consecutive patients undergoing ERCP will be included in the study
We will also assess:
Evaluate the failure of biliary cannulation in our setting. Evaluate predictive factors for difficult cannulation and cannulation failure using ESGE criteria.
Design an "a priori" predictive model for difficult cannulation and cannulation failure.
Cost study: record of materials used.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years
Signed informed consent
Patients indicated for ERCP
Disqualifiers
INR > 1.5
Platelets < 50,000/mm³
Patients with a prior endoscopic sphincterotomy
Papilla of Vater not accessible via duodenoscope (gastric or duodenal stenosis due to neoplasm) or gastric surgery (Billroth II, Roux-en-Y)
Trial population
All the consecutive patients with an indication of a endoscopic retrograde cholangiopancreatography meeting inclusion and exclusion criteria will be included
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Difficult biliary cannulation
(\> 5 minutes duration until cannulation, \> 5 cannulation attempts, \> 1 passage of the guidewire into the main pancreatic duct
Time frame
1 yearSecondary outcomes
1
Failure of biliary cannulation
Not possibility of biliary cannulation during the procedure
Time frame
1 year2
Predictive factors for difficult cannulation and cannulation failure
Factors independently associated with difficult cannulation and cannulation failure
Time frame
1 year3
Designing an "a priori" predictive model for difficult cannulation and cannulation failure
Considering the factors independently associated with difficult cannulation and cannulation failure
Time frame
1 year4
To carry out a cost study
considering direct costs of the procedure
Time frame
1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: