Bile Duct Obstruction, Klatskin's Tumor
Conditions
Keywords
Malignant hilar stricture
Brief summary
The overall median survival of nonresectable malignant hilar obstruction in most series has been less than 6 months. Most patients with malignant hilar obstruction present with advanced disease, making palliative endoscopic drainage the principal therapeutic option. However, the optimal endoscopic management strategy is contentious. Almost all of the published data comparing plastic and metallic stents relate to distal tumors (those of the pancreas, common bile duct and ampulla). Stent patency, complication rates, and cost-effectiveness have favored metallic stents when compared with plastic stents in patients with distal malignant obstruction expected to live at least 3 to 6 months. There are few comparative study as to whether self-expanding metallic or plastic stent, especially DLS (double layer plastic stent) are preferable in the technical success, stent patency, and cost-effectiveness for palliating malignant hilar obstruction. The study was designed to compare the the technical success, stent patency, and cost-effectiveness of self-expandable metal stent and DLS in patients with malignant hilar obstruction.
Interventions
DEVICESEMS insertion
Self-expandable metallic stent will be inserted for malignant hilar obstruction.
DEVICEDLS insertion
DoubleLayer plastic stent will be inserted for malignant hilar obstruction.
Sponsors
Soon Chun Hyang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient over 18 years old * Patient with malignant hilar obstruction
Exclusion criteria
* No written informed consent * Patient with uncorrectable severe coagulopathy * Indication for surgical operation * Karnofsky score \< 60%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stent patency | Up to 2 years | Interval time (d) from stent insertion to occlusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause complications | Up to 2 years | Early or Late complications * asymptomatic hyperamylasemia * pancreatitis (mild/moderate/severe) * cholecystitis * cholangitis * recurrent jaundice * Internal migration * external migration * occlusion |
| Cost-effectiveness | Up to 2 years | Total Cost for SEMS and DLS group * ERCP cost * Total ERBD cost (DLS or metal) * Total hospitalization cost * Cost for session x No. of session * Total (DLS vs. metal)cost /session |
| Mortality | Up to 2 years | — |
| Technical success | within 24 hr after stent insertion | * Successful insertion of bilateral or unilateral stent insertion. * Time to adequate expansion (70% of maximal expanded diameter was dilated state) in metal stent ≤ 24 hrs * No stent migration within 24 hrs |
Countries
South Korea
Contacts
Primary ContactDo Hyun Park, MD
Backup ContactTae Hoon Lee, MD
Outcome results
None listed