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Evaluation of the efficacy of ZEO STENT TM plus with a 14mm diameter for the distal biliary obstruction by pancreatic cancer.

Not Applicable
Conditions
Distal biliary obstruction by pancreatic cancer.
Registration Number
JPRN-UMIN000032797
Lead Sponsor
Cancer and Infection Disease Center Komagome Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

1)Massive ascites. 2)Uncontrolled other organ diseases 3)Biliary obstruction at the hilar part. 4)Unachievable ERCP due to post-abdominal surgery state including gastrectomy. 5)Unachievable ERCP due to difficult cannulation. 6)Distal duodenal obstruction. (Post-treatment state by stent placement excluded.) 7) Inappropriate patients for study.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Rate of recurrent biliary obstruction
Secondary Outcome Measures
NameTimeMethod
Stent patency duration Stent patency duration and the rate of stent function estimated by the Kaplan-Meier method Median overall survival Rate of complication Adverse events in the therapeutic period and post therapeutic period Complications related ERCP
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