Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

Samsung Medical Center

Status and phase: Withdrawn; Phase 3

Conditions: Obstructive Jaundice; Bile Duct Neoplasm

Treatments: Device: Y-stent (BONASTENT M-Hilar); Procedure: parallel stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01622803

KH0LEE

Details and patient eligibility

About

Internal biliary drainage using stent is used for malignant hilar obstruction such as cholangiocarcinoma, hepatocellular carcinoma and other malignancy including metastasis.

Bilateral drainage is more physiologic and have more long patency than unilateral drainage.

There are two methods of bilateral drainage: Y-stent and side by side.

However there are no clinical data about comparing the effectiveness of these two methods.

Therefore the investigators want to compare the clinical outcomes of two methods:

Y-stent and side by side.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥ 18 years
• patient who have obstructive jaundice (bilirubin > 2.0mg/dl) due to hilar malignancy

Exclusion criteria

• patients with endoscopic retrograde cholangiogram is not possible
• bleeding tendency (PT INR > 1.5, platelet < 50,000)
• poor general condition (ECOG 3-4) or cardiopulmonary deterioration
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

parallel stent

Active Comparator group

Description:

parallel stent insertion group

Treatment:

Procedure: parallel stent

Y-stent

Active Comparator group

Description:

Y-stent insertion group

Treatment:

Device: Y-stent (BONASTENT M-Hilar)