Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01622803

Enrollment

Registered

2012-06-19

Start date

2011-08-31

Completion date

2013-08-31

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

Bile Duct Neoplasm, Obstructive Jaundice

Brief summary

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.

Interventions

PROCEDUREparallel stent

bilateral parallel stent insertion (right and left side)

DEVICEY-stent (BONASTENT M-Hilar)

Bilateral Y-stent insertion (stent in stent type)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The time taken to insert bilateral stent	After the ERCP procedure

Countries

South Korea

Outcome results

None listed

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