Preoperative biliary drainage for pancreato-biliary tumours causing obstructive jaundice: DRainage versus OPeratio

Completed

Conditions: Jaundice, bile duct tumour, pancreas tumour, Papilla of Vater tumour
Cancer
Digestive system tumours

Registration Number: ISRCTN31939699

Lead Sponsor: Academic Medical Centre (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 210

Inclusion Criteria

1. Clinical diagnosis of obstructive jaundice due to a pancreatic head or periampullary tumour
2. A serum bilirubin level of greater than 40 µmol/l and less than 250 µmol/l at randomisation
3. A spiral Computed Tomography (CT) scan according to standard protocol without metastases or local tumour ingrowth in the portal or mesenteric vessels of greater than 180°
4. Referred for surgical treatment to one of the participating centres
5. Time between CT and randomisation less than or equal to four days
6. Informed consent

Exclusion Criteria

1. Aged greater than 85 years or severe co-morbidity (Karnofsky less than 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 tumour growth) defined as vomiting, nausea and/or oral intake less than 1 l/day

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with severe complications due to drainage or postoperative within 120 days after randomisation (90 days after surgery).

Secondary Outcome Measures

Name	Time	Method
1. Hospital stay<br>2. Number of extra invasive diagnostic procedures<br>3. Costs<br>4. Quality of life<br>5. Analysis of CT criteria for resectability