Biliary Tract Neoplasms
Conditions
Brief summary
The purpose of this study is to compare the duration of stent patency between partially covered and fully covered SEMS for palliation of malignant distal bile duct obstruction.
Detailed description
Endoscopic stent placement has been used as a principle palliative method in patients with unresectable distal malignancy biliary obstruction. It has been pivotal in providing relief from obstructive jaundice, improving the quality of life, and allowing the maintenance of chemotherapy. Although SEMSs have been reported to be superior to plastic stents in terms of stent patency, they still have some debatable issues ; in uncovered SEMS, stent occlusion due to epithelial hyperplasia and tumor ingrowth through the metal mesh is a frequent problem, whereas covered SEMSs are prone to migration. The aim of the current study is to compare the duration of stent patency between partially covered and fully covered SEMS as a primary objective, and investigate overall patient survival, stent occlusion rate, and incidence of adverse events including stent dysfunction as secondary objectives.
Interventions
DEVICEpartially covered SEMS
Used for palliation of inoperable malignant distal bile duct obstruction.
DEVICEfully covered SEMS
Used for palliation of inoperable malignant distal bile duct obstruction.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1.\> 19years 2.malignant biliary obstruction, 2 cm distal to hilum 3.unsuitable for curative surgical resection owing to metastasis, locally advanced stage, high operation risk, or patient's refusal
Exclusion criteria
* 1.history of biliary surgery except cholecystectomy 2.history of SEMS placement 3.coagulopathy (INR\>1.5, Platelet\<50000) 4.expected survival \> 3 months based on Karnofsky performance score 5.duodenal stricture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| duration of stent patency | From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | From the date of randomization until the date of death from any cause, assessed upto 12 months |
| stent occlusion rate | From the date of randomization until the date of first documented stent occlusion, assessed up to 12 months |
| stent related complication | From the date of randomization until the date of first documented stent related complication, assessed up to 12 months |
Countries
South Korea
Contacts
Primary ContactJong Kyun Lee, M.D., Ph.D.
Outcome results
None listed