The purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with malignant hilar biliary obstruction who are treated by unilateral or bilateral stenting.
Malignant hilar biliary obstruction is a common clinical manifestation and it can be caused by cholangiocarcinoma, gallbladder carcinoma, liver cancer, or other metastatic carcinoma. Most patients with malignant hilar biliary obstruction are unresectable at diagnosis. Biliary stenting has been widely used in palliative treatment of malignant hilar biliary obstruction. Hilar biliary obstruction usually involves the bifurcation of the biliary tract. Some researchers recommended unilateral stenting for malignant hilar biliary obstruction because drainage of 25% of entire liver can achieve the clinical success of biliary drainage. However, some researchers recommended bilateral stenting for malignant hilar biliary obstruction because some researches demonstrated that bilateral stenting can achieve a longer stent patency.In addition, there was no significant difference in post stenting survival between patients who were treated by unilateral or bilateral stenting. Therefore, it remains under debate whether unilateral or bilateral stenting is better in the treatment of malignant hilar biliary obstruction. The purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with malignant hilar biliary obstruction who are treated by unilateral or bilateral stenting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Self-expandable biliary nitinol alloys stent
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Stent patency (Stent dysfunction is suspected when the patient experiences recurrence of jaundice)
Stent dysfunction is suspected when the patient experiences recurrence of jaundice.
Time frame: From the date of randomization until the date of first documented stent dysfunction, assessed up to 10 months
Overall survival
From the date of randomization until the date of first documented death from any cause.
Time frame: From the date of randomization until the date of first documented death from any cause, assessed up to 12 months
Stent dysfunction free-patient survival
From the date of randomization until the date of first documented stent dysfunction or the date of death from any cause, whichever came first.
Time frame: From the date of randomization until the date of first documented stent dysfunction or the date of death from any cause, whichever came first, assessed up to 10 months.
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