Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

Samsung Medical Center

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Bile Duct Neoplasm Obstructive Jaundice

Interventions

parallel stentPROCEDURE

bilateral parallel stent insertion (right and left side)

Y-stent (BONASTENT M-Hilar)DEVICE

Bilateral Y-stent insertion (stent in stent type)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

The time taken to insert bilateral stent

Time frame: After the ERCP procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.