Comparison of Loop-tip Cook Medical® Wire Versus Traditional Endoscopic Technique
- Conditions
- Complications of Surgical and Medical Care: General Terms
- Registration Number
- NCT02232451
- Lead Sponsor
- Azienda Ospedaliera San Paolo
- Brief Summary
The purpose of this 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 post-ERCP pancreatitis in high-risk patients.
- Detailed Description
Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complication and post-ERCP pancreatitis (PEP) rate than the conventional biliary tree access 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.
Type of study: Multicentric, prospective and randomized trial
Patients: PEP high-risk patients underwent ERCP for benign biliary pathology
Number of patients: 320 patients (160 for each group)
Aim:
Primary end point: The evaluation of the incidence of PEP . Secondary end point: The evaluation of CBD percentage cannulation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
- high risk patients for post-ERCP pancreatitis
- age < 18 yrs
- allergy to the contrast medium
- previous surgery
- neoplastic bilio-pancreatic disease
- previous EBS
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The evaluation of the incidence of PEP loop20216
- Secondary Outcome Measures
Name Time Method The evaluation of CBD percentage cannulation. loop20216
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