Status:
UNKNOWN
Two-in-one Covered and Uncovered Metal Stent
Lead Sponsor:
Ajou University School of Medicine
Conditions:
Extrahepatic Bile Duct Cancer
Pancreatic Cancer
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
Endoscopic placement of a self-expandable metal stent (SEMS) is the principle method for palliation of inoperable malignant distal biliary obstruction. However, none of bare, covered, and anti-reflux ...
Detailed Description
Endoscopic placement of a self-expandable metal stent (SEMS) is the principle method for palliation of inoperable malignant distal biliary obstruction. As the survival time for those patients has impr...
Eligibility Criteria
Inclusion
- ㆍMalignant biliary obstruction, 2 cm distal to the hilum ㆍNot eligible for curative surgical resection owing to metastasis, locally advanced stage, or high operation risk ㆍEastern Cooperative Oncology Group Performance status 0-3
Exclusion
- ㆍBeing evaluated for potential benign biliary stricture or possible operation ㆍHistory of biliary surgery except cholecystectomy ㆍCoagulopathy (International normalized ratio \>1.5, platelet count \<50,000) ㆍCoexist other organ dysfunction (American Society of Anesthesiologist physical status grade III or IV) ㆍInability to obtain informed consent
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04337333
Start Date
May 1 2016
End Date
December 31 2021
Last Update
July 21 2021
Active Locations (2)
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1
Ajou University Hospital
Suwon, Gyeong Gi Do, South Korea, 443-721
2
Ajou University Hospital
Suwon, Gyeonggido, South Korea, 443-380