Post-ERCP Pancreatitis
Conditions
Keywords
loop-tip, ERCP, cannulation of CBD
Brief summary
Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complications and post-ERCP (Endoscopic retrograde cholangiopancreatography) pancreatitis (PEP) rate than the conventional biliary tree access with cannulotome (CT-25 Cook Medical) with contrast injection even if results are conflicting. the aim of our study is to test a new guide-wire (loop-tip wire), with a loop in the tip, for the prevention of PEP and biliary tree access, in PEP high-risk patients.
Interventions
DEVICELoop-tip wire (Cook Medical) for the cannulation of the CBD
DEVICECannulotome CT-25mm Cook Medical
Sponsors
Hospital San Paolo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* high-risk patients for post-ERCP pancreatitis
Exclusion criteria
* age \< 18 years * allargy to the contrast medium * previous biliary or gastric surgery * neoplastic patients * previous biliary or pancreatic sphincterotomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| post ERCP pancreatitis rate | up to 4 weeks | participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of attempts to obtain the cannulation of CBD and number of participants with adverse events as a measure of safety and tolerability | up to 4 weeks | participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
Countries
Italy
Outcome results
None listed