Bile Duct Obstruction, Disorder of Bile Duct Stent, Neoplasms
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICEEUS-guided biliary drainage with a hybrid metallic stent
EUS-guided biliary drainage with a newly designed hybrid metallic stent
Sponsors
Inje University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The stent patency rate | Up to 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Patients' survival rate | Up to 48 weeks |
| Complication rate related to the hybrid stents | Up to 48 weeks |
Countries
South Korea
Outcome results
None listed