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Efficacy of inside metallic stent for benign biliary stricture which persisted after plastic stenting: Multicenter prospective observational study

Not Applicable
Conditions
Benign biliary stricture
Registration Number
JPRN-UMIN000027599
Lead Sponsor
Okayama University Hospital Department of Gastroenterology
Brief Summary

The technical success rate of intraductal FCSEMS placement was 100% The rate of successful stent removal at four months was 100% and stricture resolution was observed in 91% of patients. Bile leak due to guidewire injury occurred in one patient, but stent migration or stent-induced de novo stricture did not occur in any patient. The stricture recurrence rate was 16%, and the median(interquartile range)follow-up duration was 2.8(1.6-3.3)years. 1-year and 2-year recurrence free rate were 89% and 84%

Detailed Description

Not available

Recruitment & Eligibility

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

Not provided

Exclusion Criteria

1.Patients with performance status 3 or 4 2.Patients with severe complications to other organs. 3.Stricture of intrahepatic bile duct 4.Age<20 5.Patients without informed concent 6.The size of bile duct size showed less than 8 mm on first ERC finding. 7.Patients with severe coagulation dysfunction. 8.Patients with hepaticojejunostomy 9.Patients judged inappropriate by chief medical examiner.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Rate of stricture resolution at metallic stent removal after 4 month stent placement
Secondary Outcome Measures
NameTimeMethod
1.Success rate of stent placement 2.Success rate of stent removal 3. Rate of stricture recurrence 4. Adverse events
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