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The efficacy and safety of non-flared fully covered self expandable metalic stent for benign biliary duct stricture

Not Applicable
Conditions
Symptomatic benign biliary duct stricture
Registration Number
JPRN-UMIN000025027
Lead Sponsor
Kitasato University
Brief Summary

The success rate of FCSEMS placement was 100% (22/22), and 81.8% (18/22) could be placed for 6 months. 19 of 22 patients were excluded, and the stenosis improvement rate was 89.5% (17/19), and the median bile duct diameter improved to 6.0 [1-9] mm. The median observation period after removal was 597 days [365-1651], and the recurrence rate was 5.9% (1/17).

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
22
Inclusion Criteria

Not provided

Exclusion Criteria

1) Performance status < 4 2) patients be impossible to distinguish from IgG4 related disease and PSC 3) patients with severe hemorrhagic diathesis 4) patients with metal allergy 5) diameter of bile duct is 5mm or less 6) patients that the physician in charge consider not suitable for inclusion

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Efficacy of non-flared FCSEMS after placement for 6 months for benign biliary duct stricture
Secondary Outcome Measures
NameTimeMethod
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