Pilot Study on the Usefulness of Endoscopic Ultrasound-guided Choledochoduodenostomy With a Newly Designed Hybrid Metallic Stent
20 Years
N/A
Both
Bile Duct Obstruction, Disorder of Bile Duct Stent, Neoplasms
Trial Information
Pilot Study on the Usefulness of Endoscopic Ultrasound-guided Choledochoduodenostomy With a Newly Designed Hybrid Metallic Stent
Endoscopic ultrasound-guided choledochoduodenostomy with a fully covered metallic stent was
a safe and effective method in patients with distal 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 choledochoduodenostomy.
Inclusion Criteria:
- Age > 20 years
- The presence of an unresectable distal 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The stent patency rate
Outcome Time Frame:
Up to 48 weeks
Safety Issue:
No
Principal Investigator
Sang Soo Lee, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul , South Korea
Authority:
South Korea: Institutional Review Board
Study ID:
S2012-1819-0002
NCT ID:
NCT01862198
Start Date:
February 2010
Completion Date:
August 2013
Related Keywords:
- Bile Duct Obstruction
- Disorder of Bile Duct Stent
- Neoplasms
- Bile Duct Diseases
- Neoplasms
- Cholestasis
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