Biliary Tract Cancer
Conditions
Keywords
distal malignancy of the extra-hepatic biliary tract, metallic biliary stents, covered biliary stents, uncovered biliary stents
Brief summary
Patency duration of covered metal stents as compared with uncovered metal stents in the management of malignant strictures of the extra-hepatic biliary tree.
Detailed description
Consecutive patients with malignant strictures of the extra-hepatic biliary tree considered unfit for surgical excision Placement of covered or uncovered metal stents in patients with and without gallbladder on the basis of a computer-generated randomization list Evaluation of clinical outcome, survival, complications, and quality of life. Evaluation of the cost and efficacy of the two types of metal stents.
Interventions
DEVICEcovered biliary stents
endoscopic placement of covered biliary stents
DEVICEuncovered biliary stents
endoscopic placement of uncovered biliary stents
Sponsors
Nuovo Ospedale Civile S.Agostino Estense
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients with symptomatic malignant obstruction of the extra-hepatic biliary tree * not eligible for surgical intervention * able to provide informed consent
Exclusion criteria
* benign biliary obstruction * previous surgery of the biliary tract * life expectancy \< 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relief of malignant biliary obstruction | six months | Clinical assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cost/effecacy | 6 months | cost and effectiveness of covered versus uncovered biliary stents |
Other
| Measure | Time frame | Description |
|---|---|---|
| gallbladder in situ | 6 months | Acute cholecystitis could affect the clinical outcome of patients when a covered stent is used |
Countries
Italy
Outcome results
None listed