Unilateral Stenting Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction

Xuzhou Central Hospital (Xuzhou Fourth People's Hospital)

Status: Completed

Conditions: Hepatocellular Carcinoma; Cholangiocarcinoma; Gallbladder Carcinoma

Treatments: Device: biliary stent

Study type: Interventional

Funder types: Other

Identifiers

NCT02649712

xzxy20160106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Unilateral stent

Active Comparator group

Description:

Patients undergo placement of unilateral biliary stent on day 1.

Treatment:

Device: biliary stent

Bilateral stents

Active Comparator group

Description:

Patients undergo placement of bilateral biliary stents on day 1.

Treatment:

Device: biliary stent