Cholangiocarcinoma, Gallbladder Carcinoma, Hepatocellular Carcinoma
Conditions
Brief summary
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
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.
Interventions
DEVICEbiliary stent
Self-expandable biliary nitinol alloys stent
Sponsors
Xuzhou Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Malignant hilar biliary obstruction; 2. Unresectable cases
Exclusion criteria
1. Bismuth I patients; 2. inability to obtain informed consent; 3. Eastern Cooperative Oncology Group performance status of 4; 4. severe dysfunction in other organs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stent patency (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 | Stent dysfunction is suspected when the patient experiences recurrence of jaundice. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 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 death from any cause. |
| 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, assessed up to 10 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. |
Countries
China
Outcome results
None listed