NL-OMON56845
Not yet recruiting
Not Applicable
Primary percutaneous stenting of the bile ducts in patients with resectable perihilar cholangiocarcinoma - a pilot study - TESLA 2 pilot
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bile duct cancer
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 12
- Status
- Not yet recruiting
- Last Updated
- last year
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.
- •Resectable pCCA on imaging with histopathological confirmation or high
- •clinical suspicion (as determined by the multidisciplinary hepatobiliary team).
- •Hyperbilirubinemia (a combination of a total bilirubin level \>50 mmol/l.
- •Age above 18 years
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 the presence of
- •both fever (i.e. body temperature \>38\.5°C) combined with leucocytosis (i.e. \>\=10
- •\*109/L) without clinical or radiological evidence of acute cholecystitis
- •Uncorrectable coagulation disorder.
- •Uncorrectable contrast allergy.
Outcomes
Primary Outcomes
Not specified
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