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A randomized controlled trial to compare antireflux metal stent and conventional covered metal stent for nonresectable distal malignant biliary obstructio

Not Applicable
Conditions
onresectable distal malignant biliary obstruction
Registration Number
JPRN-UMIN000014784
Lead Sponsor
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
104
Inclusion Criteria

Not provided

Exclusion Criteria

1. Endoscopic approach to the biliary system is impossible 2. Hilar biliary obstruction 3. Performance status is four 4. Gastrointestinal obstruction distal to the papilla (patients whose gastrointestinal obstruction was resolved via a stent or surgical bypass can be included) 5. Severe comobidities in other organs 6. Pregnant women or those suspected of pregnancy 7. Written informed consent not obtained 8. Patients considered ineligible by attending physicians

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Time to recurrent biliary obstrution after the placement of metal stent
Secondary Outcome Measures
NameTimeMethod
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