Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bile Duct Neoplasm Obstructive Jaundice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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parallel stent

parallel stent insertion group

Group Type ACTIVE_COMPARATOR

parallel stent

Intervention Type PROCEDURE

bilateral parallel stent insertion (right and left side)

Y-stent

Y-stent insertion group

Group Type ACTIVE_COMPARATOR

Y-stent (BONASTENT M-Hilar)

Intervention Type DEVICE

Bilateral Y-stent insertion (stent in stent type)

Interventions

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parallel stent

bilateral parallel stent insertion (right and left side)

Intervention Type PROCEDURE

Y-stent (BONASTENT M-Hilar)

Bilateral Y-stent insertion (stent in stent type)

Intervention Type DEVICE

Other Intervention Names

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bilateral pig tail plastic stent BONASTENT M-Hilar, Standard Sci Tech Inc, Seoul, South Korea

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No