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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Self-expandable metallic stent will be inserted for malignant hilar obstruction.
DoubleLayer plastic stent will be inserted for malignant hilar obstruction.
Soon Chun Hyang University Cheonan Hospital
Cheonan, 23-20 Bongmyung-dong, South Korea
RECRUITINGInje University Pusan Paik Hospital
Pusan, Busanjin-gu, Gaegeum-dong, South Korea
RECRUITINGAsan Medical Center
Seoul, Pungnap-2dong, Songpagu, South Korea
RECRUITINGEulji University Hospital
Daejeon, Seo-gu, Dunsan-dong, South Korea
RECRUITINGStent patency
Interval time (d) from stent insertion to occlusion
Time frame: Up to 2 years
All cause complications
Early or Late complications * asymptomatic hyperamylasemia * pancreatitis (mild/moderate/severe) * cholecystitis * cholangitis * recurrent jaundice * Internal migration * external migration * occlusion
Time frame: Up to 2 years
Cost-effectiveness
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
Time frame: Up to 2 years
Mortality
Time frame: Up to 2 years
Technical success
* 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
Time frame: within 24 hr after stent insertion
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