Endoscopic versus percutaneous biliary drainage in resectable hilar cholangiocarcinoma.
Suspended
- Conditions
- bile duct tumor, jaundice, biliary drainage
- Registration Number
- NL-OMON28228
- Lead Sponsor
- Academic Medical Center (AMC)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 106
Inclusion Criteria
Changed 17-jun-2014
- Diagnosis or suspicion of perihilar cholangiocarcinoma (pHCCA)
Exclusion Criteria
- Incomplete recovery from side-effects of any prior stenting attempt
- Signs of active cholangitis, defined as Leukocytes ≥ 10 *109/L or antibiotic treatment for a
suspicion of cholangitis within the past 5 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The combined incidence of severe complications related to EBD or PTBD between the initial drainage after treatment allocation (i.e. the index drainage procedure) and the day of explorative laparotomy. A severe complication is defined as any complication related to biliary drainage, requiring an additional invasive or surgical intervention with subsequent prolonged hospital stay or death, or readmission for drainage related morbidity. When explorative laparotomy is cancelled a substitute endpoint will be used in analysis of the<br>primary endpoint: (1) the total number of severe drainage-related complications between randomization and 1 week after biopsy in patients in whom the laparotomy is cancelled due to a diagnosis of distant metastatic disease, or (2) the total number of severe drainage-related<br>complications within 3 months after randomization in patients in whom the laparotomy is cancelled due to physical deterioration.
- Secondary Outcome Measures
Name Time Method