Unilateral Stenting Versus Bilateral Stenting for 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.

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.

From the date of randomization until the date of first documented stent dysfunction, assessed up to 10 months

From the date of randomization until the date of first documented death from any cause, assessed up to 12 months

From the date of randomization until the date of first documented stent dysfunction or the date of death from any cause, whichever came first.

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.

Inclusion Criteria: Malignant hilar biliary obstruction; Unresectable cases Exclusion Criteria: Bismuth I patients; inability to obtain informed consent; Eastern Cooperative Oncology Group performance status of 4; severe dysfunction in other organs.

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