CBD obstruction malignant extrahepatic biliairy obstruction
Conditions
Interventions
After informed consent, 300 (primary) + 160 (recurrent) patients will be
randomized to: a) plastic stent, b) uncovered SEMS, or c) covered SEMS in a
1:1:1 ratio.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medical effects, quality of life, costs/cost-effectiveness in 2 strata (primary and recurrent patients). Initially plastic stents vs. uncov. + cov. SEMS will be compared, and secondarily uncov. vs. cov. SEMS. The prognostic model will present a score to predict survival in patients with primary and recurrent CBD obstruction and will be used to guide stent choice. | — |
Countries
Netherlands
Outcome results
None listed