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

Inje University

Status and phase: Completed; Phase 4

Conditions: Neoplasms; Bile Duct Obstruction; Disorder of Bile Duct Stent

Treatments: Device: EUS-guided biliary drainage with a hybrid metallic stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01862198

S2012-1819-0002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 27 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

hybrid metallic stent

Experimental group

Description:

Patients group who were inserted a hybrid metallic stent

Treatment:

Device: EUS-guided biliary drainage with a hybrid metallic stent