Status:
COMPLETED
Safety and Efficacy of a Newly Developed Baby-sphincterotome for Bile Duct Cannulation
Lead Sponsor:
Ruhr University of Bochum
Conditions:
Bile Duct Diseases
Eligibility:
All Genders
18+ years
Brief Summary
Precut-sphincterotomy is a well established alternative after repeated futile attempts for common bile duct (CBD) cannulation with standard catheters and/or guide-wires fail. Commonly used devices ins...
Detailed Description
Interventional procedures at the bile or pancreatic duct require selective cannulation of the desired duct and sometimes endoscopic sphincterotomy (ES). If it is not possible to achieve selective acce...
Eligibility Criteria
Inclusion
- Evidence for bile duct obstruction with a visible stone or tumor, dilated common bile duct \> 7 mm (or \> 9 mm in cholecystectomised patients) by ultrasonography and CT-scan or MRCP/EUS, an elevated serum bilirubin level \> 1.4 mg/dl, and serum alkaline phosphatase \> 200 U/l with clinical suspicion of obstruction without evidence for cholestatic liver disease.
Exclusion
- Patients with severe coagulation disorders or distorted anatomy of the major papilla (malignant infiltration of the papilla, papillary porus not identifiable, impacted stone) and patients with former gastro-duodenal resection (e.g. BII-anatomy) were excluded
Key Trial Info
Start Date :
June 1 2000
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
1886 Patients enrolled
Trial Details
Trial ID
NCT01493076
Start Date
June 1 2000
End Date
November 1 2011
Last Update
December 15 2011
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