Our study is the prospective randomized study for efficacy of uncovered double bare metallic stent compared to uncovered single bare metallic stent in malignant biliary obstruction
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
73
The patients who had malignant biliary obstruction will be enrolled our study. Enrolled patient will be randomized to three group (uncovered double bare metallic stent (S\&G Biotech.) vs. uncovered single bare metallic stent (S\&G Biotech.) vs. uncovered single bare metallic stent (Taewoong Medical.)). After metallic biliary stent insertion, enrolled patients will be followed at least one time per one month. Blood test (including total bilirubin, gamma-GT) will be done for follow-up study. During follow-up period, if biliary obstruction is suspected, imaging study (CT or MRCP) will be done. With such follow-up tools, we compare 6-month patency rate and median patency duration among three groups.
The patients who had malignant biliary obstruction will be enrolled our study. Enrolled patient will be randomized to three group (uncovered double bare metallic stent (S\&G Biotech.) vs. uncovered single bare metallic stent (S\&G Biotech.) vs. uncovered single bare metallic stent (Taewoong Medical.)). After metallic biliary stent insertion, enrolled patients will be followed at least one time per one month. Blood test (including total bilirubin, gamma-GT) will be done for follow-up study. During follow-up period, if biliary obstruction is suspected, imaging study (CT or MRCP) will be done. With such follow-up tools, we compare 6-month patency rate and median patency duration among three groups.
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Median patency duration
Primary end point : A. Median patency duration
Time frame: Approximately 6 months later since the date of stent insertion
6-months patency rate
Secondary end point : A. 6-months patency rate
Time frame: Approximately 6 months later since the date of stent insertion
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The patients who had malignant biliary obstruction will be enrolled our study. Enrolled patient will be randomized to three group (uncovered double bare metallic stent (S\&G Biotech.) vs. uncovered single bare metallic stent (S\&G Biotech.) vs. uncovered single bare metallic stent (Taewoong Medical.)). After metallic biliary stent insertion, enrolled patients will be followed at least one time per one month. Blood test (including total bilirubin, gamma-GT) will be done for follow-up study. During follow-up period, if biliary obstruction is suspected, imaging study (CT or MRCP) will be done. With such follow-up tools, we compare 6-month patency rate and median patency duration among three groups.