Bile Duct Obstruction Clinical Trial
Official title:
Uncovered Self-expandable Metal Stent Versus DoubleLayer Plastic Stent for Malignant Hilar Stricture: a Prospective Randomized Multicenter Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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