Bile Duct Cannulation, Endoscopic Retrograde Cholangiopancreatography (ERCP)
Conditions
Keywords
Patients undergoing endoscopic retrograde cholangiopancreatography for the first time, Particular focus on patients who meet predefined criteria for a difficult bile duct cannulation
Brief summary
This research project will compare the use of the double wire technique with the placement of a pancreatic duct (PD) stent to achieve deep biliary cannulation without the use of a precut papillotomy. Currently, the data supporting either of these approaches is limited to the referenced case series. More data on the success and complication rates of these techniques are needed. The investigators believe either of these approaches would be preferred by less experienced endoscopists to precut papillotomy. Consequently, it is important to differentiate these techniques and identify which patients may benefit from one or both.
Interventions
PROCEDUREPancreatic wire placement
Placement of a pancreatic wire to facilitate bile duct cannulation
PROCEDUREPancreatic duct stent
Placement of a pancreatic duct stent to facilitate bile duct cannulation
Sponsors
Northwestern University
University of Oklahoma
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* First time ERCP
Exclusion criteria
* Successful bile duct cannulation within six minutes * Planned pancreatic duct therapy * Planned pancreatobiliary manometry * Prior successful ERCP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cannulation success rate | Cannulation is assessed during the index procedure; procedure-related complications are assessed within one week of the procedure |
Secondary
| Measure | Time frame |
|---|---|
| Complication rate | One week |
Countries
United States
Outcome results
None listed