Unilateral Stenting Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction

Not Applicable

Completed

• Conditions: Gallbladder Carcinoma; Hepatocellular Carcinoma; Cholangiocarcinoma
• Interventions: Device: biliary stent

• Registration Number: NCT02649712
• Lead Sponsor: Xuzhou Central Hospital

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.

Study Timeline

• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-01-06
• Study First Posted: 2016-01-07
• Study Start: 2016-01-20
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-18
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unilateral stent	biliary stent	Patients undergo placement of unilateral biliary stent on day 1.
Bilateral stents	biliary stent	Patients undergo placement of bilateral biliary stents on day 1.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Xuzhou Central Hospital; 🇨🇳 Xuzhou, Jiangsu, China