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Comparison of the duration of recurrent bile duct obstruction between two 10 French Plastic Stent and fully covered Self expandable metallic stent for non-resected distal malignant bile duct stenosis: a multicenter randomized non-inferiority stud

Not Applicable
Recruiting
Conditions
Patients with non-resected distal malignant bile duct obstruction
Registration Number
JPRN-UMIN000044178
Lead Sponsor
The Jikei University school of medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
134
Inclusion Criteria

Not provided

Exclusion Criteria

1. Cases in which endoscopic retrograde cholangiography is difficult. 2. Patients with peri-hilar bile duct obstruction. 3. Patients with altered gastrointestinal anatomy excluding Billroth-I reconstruction. 4. Patients with serious complications in other organs. 5. Performance status 4 6. Cases of pregnancy or possible pregnancy 7. Cases deemed inappropriate by the principal investigator or sub-investigator 8. Underage patients(less than 20 years old)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Comparison of the duration of recurrent bile duct obstruction between two 10 French PS and one fully covered SEMS for non-resected distal malignant bile duct stenosis.
Secondary Outcome Measures
NameTimeMethod
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