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

Neoplasms Clinical Trial

Official title:

Pilot Study on the Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862198
• Other study ID #: S2012-1819-0002
• Status: Completed
• Phase: Phase 4
• First received: May 19, 2013
• Last updated: November 29, 2013
• Start date: September 2011
• Est. completion date: August 2013

Study information

• Verified date: November 2013
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Diseases
• Bile Duct Obstruction
• Cholestasis
• Disorder of Bile Duct Stent
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Inje University Ilsan Paik Hospital	Koyang
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The stent patency rate		Up to 48 weeks	No
Secondary	Patients' survival rate		Up to 48 weeks	No
Secondary	Complication rate related to the hybrid stents		Up to 48 weeks	Yes