NL-OMON56129
Recruiting
Phase 2
Primary percutaneous placement of metal stents for palliative biliary drainage in patients with a primary malignant perihilar stricture - TESLA
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- bile duct cancer
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 112
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent must be given according to ICH/GCP, and
- •national/local regulations.
- •Unresectable primary malignant perihilar obstruction on imaging with
- •histopathological confirmation or high clinical suspicion (as determined by the
- •multidisciplinary hepatobiliary team)
- •Symptomatic hyperbilirubinemia (a combination of a total bilirubin level \>20
- •mmol/l, and/or jaundice and/or loss of appetite and/or dark urine and/or
- •steatorrhea)
Exclusion Criteria
- •Fluctuation or spontaneous decrease of a total bilirubin level before start
- •of any treatment suggesting potential benign origin.
- •Patients who underwent previous drainage procedures endoscopically or
- •percutaneously with an internalized biliary catheter
- •Clinical signs of cholangitis. Cholangitis was defined as both fever (i.e.
- •body temperature \>38\.5°C) and leucocytosis (i.e. \>\=10 \*10^9/L) without clinical
- •or radiological evidence of acute cholecystitis. Patients who underwent ERCP
- •are eligible, providing no papillotomy was performed and there are no signs of
- •cholangitis.
Outcomes
Primary Outcomes
Not specified
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