NL-OMON53463
Recruiting
Not Applicable
Primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction. - TESLA RCT
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 148
- 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.
- •MHBO on imaging with histopathological confirmation or high clinical
- •Ineligible for surgical resection.
- •Hyperbilirubinemia (a combination of a total bilirubin level \>50 mmol/l.
Exclusion Criteria
- •Fluctuation or spontaneous decrease of a total bilirubin level before start
- •of any treatment suggesting a potential non\-malignant diagnosis.
- •Patients who underwent previous biliary drainage procedures endoscopically or
- •percutaneously. Patients who underwent an attempted but failed ERCP are
- •eligible only when no papillotomy or cannulation was performed.
- •Clinical signs of cholangitis. Cholangitis is defined as the presence of both
- •fever (i.e. body temperature \>38\.5°C) and leucocytosis (i.e. \>\=10 \*109/L)
- •without clinical or radiological evidence of acute cholecystitis (22\).
- •Uncorrectable coagulation disorder.
- •Uncorrectable contrast allergy.
Outcomes
Primary Outcomes
Not specified
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