A Prospective Randomized Study for Efficacy of Uncovered Double Bare Metallic Stent Compared to Uncovered Single Bare Metallic Stent in Malignant Biliary Obstruction

Study Overview
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Brief Summary
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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

Conditions
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Malignant Biliary Obstruction

Intervention / Treatment
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* Procedure: metallic biliary stent insertion (double bare - S&G Biotech.)
* Procedure: metallic biliary stent insertion (single bare - S&G Biotech.)
* Procedure: metallic biliary stent insertion (single bare - Taewoong Medical.)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: uncovered double bare metallic stent (S&G Biotech.)<br>uncovered double bare metallic stent | Procedure: metallic biliary stent insertion (double bare - S&G Biotech.)<br>* 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.<br>|
| Active Comparator: uncovered single bare metallic stent (S&G Biotech.)<br>uncovered single bare metallic stent | Procedure: metallic biliary stent insertion (single bare - S&G Biotech.)<br>* 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.<br>|
| Active Comparator: uncovered single bare metallic stent (Taewoong Medical.)<br>uncovered single bare metallic stent | Procedure: metallic biliary stent insertion (single bare - Taewoong Medical.)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median patency duration | Primary end point : A. Median patency duration | Approximately 6 months later since the date of stent insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-months patency rate | Secondary end point : A. 6-months patency rate | Approximately 6 months later since the date of stent insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malignant biliary obstruction, metal stent, patency