Malignant Biliary Obstruction
Conditions
Keywords
Malignant biliary obstruction, metal stent, patency
Brief summary
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
Interventions
PROCEDUREmetallic biliary stent insertion (double bare - S&G Biotech.)
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.
PROCEDUREmetallic biliary stent insertion (single bare - S&G Biotech.)
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.
PROCEDUREmetallic biliary stent insertion (single bare - Taewoong Medical.)
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patients who had malignant biliary obstruction
Exclusion criteria
* The patients who had resectable biliary malignancy * The patients who had hilar obstruction * The patients who had duodenal obstruction * The patients who had other malignancy which is not related to biliary obstruction * The patients who had uncontrolled infection * The patients who had poor performance (ECOG =3 or 4) * The patients who were not acquired informed consent * The patients who had technically difficult structure for ERCP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median patency duration | Approximately 6 months later since the date of stent insertion | Primary end point : A. Median patency duration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-months patency rate | Approximately 6 months later since the date of stent insertion | Secondary end point : A. 6-months patency rate |
Countries
South Korea
Outcome results
None listed