Plastic or Metal Stents for Primary or Recurrent Inoperable Malignant Extrahepatic Biliary Obstructio
Completed
- Conditions
- 10018008CBD obstructionmalignant extrahepatic biliairy obstruction
- Registration Number
- NL-OMON38333
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 430
Inclusion Criteria
a. Obstructive malignancy at the level of the extrahepatic CBD,
b. Inoperability due to a poor medical condition, local irresectability or distant metastases,
c. Serum bilirubin >30 micromol/L and/or clinical symptoms of obstructive jaundice
d. Informed consent.
Exclusion Criteria
a. Malignancy involving intrahepatic bile ducts and duodenum,
b. Known history of pancreatitis or cholecystitis (unless cholecystectomy has been performed),
c. WHO performance score of 4 (100% of time in bed),
d. Unable to fill out quality of life questionnaires
e. Known history of operation of the bile ducts (p.a. choledochojejunostomy) unless cholecystectomy has been performed
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Medical effects, quality of life, costs/cost-effectiveness in 2 strata (primary<br /><br>and recurrent patients). Initially plastic stents vs. uncov. + cov. SEMS will<br /><br>be compared, and secondarily uncov. vs. cov. SEMS. The prognostic model will<br /><br>present a score to predict survival in patients with primary and recurrent CBD<br /><br>obstruction and will be used to guide stent choice. </p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>