The Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent

Inje University27 enrolled

Overview

The purpose of this study is to investigate the feasibility and safety of endoscopic ultrasound-guided biliary drainage with a newly designed hybrid metallic stent.

Endoscopic ultrasound-guided biliary drainage with a fully covered metallic stent was a safe and effective method in patients with malignant biliary obstructions and had a comparatively long patency duration. Nevertheless, the significant rate of distal stent migration cannot be ignored, suggesting the need for a newly designed metallic stent for endoscopic ultrasound-guided biliary drainage.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bile Duct Obstruction Disorder of Bile Duct Stent Neoplasms

Interventions

EUS-guided biliary drainage with a hybrid metallic stentDEVICE

EUS-guided biliary drainage with a newly designed hybrid metallic stent

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \> 20 years * The presence of an unresectable malignant biliary obstruction * Failed conventional ERCP stenting Exclusion Criteria: * Age \< 20 years * An inability to sedate the patient due to advanced heart or pulmonary diseases * A lack of informed consent

Locations (2)

Inje University Ilsan Paik Hospital

Koyang, South Korea

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

The stent patency rate

Time frame: Up to 48 weeks

Secondary Outcomes

Patients' survival rate

Time frame: Up to 48 weeks

Complication rate related to the hybrid stents

Time frame: Up to 48 weeks

Data from ClinicalTrials.gov

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