Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a LCD Stent

Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a Large Cell Niti-S (LCD) Stent

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01875549

Enrollment

Registered

2013-06-12

Start date

2013-05-31

Completion date

2016-05-31

Last updated

2016-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma, Gall Bladder Cancer, Hepatocellular Carcinoma, Malignant Lymphadenopathy, Obstruction of Biliary Tree

Brief summary

Internal biliary drainage is an useful method for a control of jaundice and cholangitis to patients who had a malignant hilar obstruction due to hepatocellular carcinoma, cholangiocarcinoma, gall bladder cancer or metastatic lymphadenopathy. Bilateral biliary drainage is more physiologic but technically difficult to compared with unilateral biliary drainage specially related to conformability and flexibility between using stents. There are no prospective clinical trials compared with these internal biliary drainage methods in hilar malignant obstruction using metal stent. Therefore, the investigators want to compare the clinical outcome of two method: Unilateral biliary stent and Bilateral biliary stent

Interventions

DEVICEstent insertion

to use a LCD stent at an unilateral or bilateral stent insertion

PROCEDUREEndoscopic retrograde cholangiopancreatoscopy(ERCP)

to use ERCP for a stent insertion in an obstructive biliary tract

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age\> 18 * diagnosis of malignancy in pathology or cytology * jaundice(Total bilirubin)\> 2.0 mg/dL * Diagnosed malignant hilar invasion to CT or other image finding

Exclusion criteria

* bleeding tendency(INR\>1.5) * Pregnancy * severe liver,kidney disease

Design outcomes

Primary

Measure	Time frame	Description
Stent patency	up to 1year	Participants will followed for the new obstruction(new jaundice) will occur.

Secondary

Measure	Time frame	Description
survival period	up to 1year	Participants will followed for 1year.

Other

Measure	Time frame	Description
complication	up to 1year	Participants will followed after stent insertion and observe a complication rate between two groups.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026