Obstructive jaundice due to a pancreatic head area (pancreas, papilla, distal bile duct) tumor.
Conditions
Interventions
1. Preoperative biliary drainage: Drainage procedure will be performed within three days after randomization for a total of 4 weeks
2. ERCP and preoperative biliary drainage will be performed by an experienced endoscopist, preferably by endoscopically insertion of a (plastic)stent
3. One stent is generally sufficient because only distal obstruction is included
4. If ERCP is not successful, patient can be referred to a center for a second attempt for endoscopic drainage or a percutaneous drainage will be performed according to local experience
5. Biliary drainage is considered adequate if a decrease of > 50% of serum bilirubin level is found after 2 weeks of drainage
otherwise the stent should be changed
6. Exactly four weeks of preoperative biliary drainage patients will undergo surgery. In case of complications after ERCP or during the biliary drainage period (cholangitis, stent occlusion) a stent
7. Other complications, such as bleeding or severe pancreatitis, should be treated according to the general locally accepted treatment protocol and/or consensus about management (46,47) and could cons
8. Preoperative nutritional support (e.g. consultation with a dietician, nutirdrink, ) is recommended in patients with a weight loss of more than 15% during the last 3 months.
Surgical treatment: Sur
Sponsors
None listed
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. Referred for surgical treatment to one of the participating centers; 5. Time between CT and randomization ≤ 4 days; 6. Informed Consent.
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 |
|---|---|
| Percentage of patients with severe complications due to drainage or postoperative within 120 days after randomisation (90 days after surgery). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hospital stay; 2. Number of extra invasive diagnostic procedures; 3. Costs; 4. Quality of Life; 5. Analysis of CT criteria for resectability. | — |
Contacts
Public ContactN.A. Gaag, van der
Academic Medical Center (AMC), Department of Surgery, P.O. Box 226600
Outcome results
None listed