periampullary cancer, jaundice, pancreas tumor
Conditions
Interventions
ERCP with placement of metal stent instead of plastic stent in jaundiced patients with resectable periampullary cancer.
Sponsors
Academic Medical Center (AMC)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of obstructive jaundice due to a pancreatic head or periampullary tumor; 2. A serum bilirubin level of > 40 µmol/l and 180 degrees; 4. Scheduled for preoperative biliary drainage by principal physician; 5. Scheduled for surgical treatment in one of the participating centres.
Exclusion criteria
Exclusion criteria: 1. Age > 85 years or severe co-morbidity (Karnofsky <50%) and other contra indications for major surgery; 2. Cholangitis/infection; 3. Previous ERCP and stenting or percutaneous biliary drainage; 4. Previous chemotherapy for this malignancy; 5. Severe gastric outlet obstruction (stenosis duodenum due to tumor growth) defined as vomiting, nausea and/or oral intake less than one l/day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of stent-related complications after preoperative biliary drainage with a metal stent. These results will be compared to those of the patients from the previous DROP trial (NTR NUMBER: NTR234) who underwent preoperative drainage with a plastic stent as well as patients without stenting. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hospital stay; 2. Number of extra invasive diagnostic procedures; 3. Costs; 4. Quality of Life. These results will be compared to those of the patients from the previous DROP trial (NTR NUMBER: NTR234) who underwent preoperative drainage with a plastic stent as well as patients without stenting. | — |
Contacts
Public ContactJ.A.M.G. Tol
Academisch Medisch Centrum Meibergdreef 9 G4-149
Outcome results
None listed