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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERCP with loop tip wire | Experimental | ERCP with loop tip wire is an endoscopic procedure to treat biliary disease. Wire guide cannulation with loop-tip is a new procedure to improve rate of biliary cannulation and reduce complication, as post-procedure pancreatitis. |
|
| ERCP for cannulation | Active Comparator | ERCP for cannulation of CBD with traditional technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERCP with loop tip wire | Device | Endoscopic retrograde cholangio-pancreatography with guide wire (loop-tip) for CBD cannulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| The evaluation of the incidence of PEP | loop20216 |
| Measure | Description | Time Frame |
|---|---|---|
| The evaluation of CBD percentage cannulation. | loop20216 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enzo Masci, MD | Hospital San Paolo | Study Director |
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| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| D002404 | Catheterization |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
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| ERCP for cannulation | Device | Endoscopic retrograde cholangio-pancreatography with traditional technique for CBD cannulation |
|
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |