Unilateral Stenting Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Unilateral Stenting Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction

Conditions
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Cholangiocarcinoma, Gallbladder Carcinoma, Hepatocellular Carcinoma

Intervention / Treatment
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* Device: biliary stent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unilateral stent<br>Patients undergo placement of unilateral biliary stent on day 1. | Device: biliary stent<br>* Self-expandable biliary nitinol alloys stent<br>|
| Active Comparator: Bilateral stents<br>Patients undergo placement of bilateral biliary stents on day 1. | Device: biliary stent<br>* Self-expandable biliary nitinol alloys stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent patency (Stent dysfunction is suspected when the patient experiences recurrence of jaundice) | Stent dysfunction is suspected when the patient experiences recurrence of jaundice. | From the date of randomization until the date of first documented stent dysfunction, assessed up to 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | From the date of randomization until the date of first documented death from any cause. | 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. | 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. |