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Completed

NCT Number: NCT01862198

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

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.

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Key information

Conditions

Bile Duct Obstruction Bile Duct Diseases Biliary Tract Diseases Cholestasis Digestive System Diseases Disorder of Bile Duct Stent Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Inje University Ilsan Paik Hospital, Koyang, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EUS-guided biliary drainage with a hybrid metallic stent

Device

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

Primary outcomes

  1. The stent patency rate

    Time frame: Up to 48 weeks

Secondary outcomes

  1. Patients' survival rate

    Time frame: Up to 48 weeks

  2. Complication rate related to the hybrid stents

    Time frame: Up to 48 weeks

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 24, 2013
Registry last updated
Dec 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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