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Internal biliary drainage is an useful method for a control of jaundice and cholangitis to patients who had a malignant hilar obstruction due to hepatocellular carcinoma, cholangiocarcinoma, gall bladder cancer or metastatic lymphadenopathy.
Bilateral biliary drainage is more physiologic but technically difficult to compared with unilateral biliary drainage specially related to conformability and flexibility between using stents.
There are no prospective clinical trials compared with these internal biliary drainage methods in hilar malignant obstruction using metal stent.
Therefore, the investigators want to compare the clinical outcome of two method: Unilateral biliary stent and Bilateral biliary stent
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unilateral stent insertion group | Active Comparator | the use of unilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP) |
|
| Bilateral stent insertion group | Active Comparator | the use of bilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stent insertion | Device | to use a LCD stent at an unilateral or bilateral stent insertion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stent patency | Participants will followed for the new obstruction(new jaundice) will occur. | up to 1year |
| Measure | Description | Time Frame |
|---|---|---|
| survival period | Participants will followed for 1year. | up to 1year |
| Measure | Description | Time Frame |
|---|---|---|
| complication | Participants will followed after stent insertion and observe a complication rate between two groups. | up to 1year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kwang hyuck Lee, PhD | Division of Gastroenterology,Department of internal medicaion,samsung medical center,Sungkyunkwan University School of Medicine | Study Director |
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| Endoscopic retrograde cholangiopancreatoscopy(ERCP) | Procedure | to use ERCP for a stent insertion in an obstructive biliary tract |
|
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D006528 | Carcinoma, Hepatocellular |
| D005706 | Gallbladder Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001660 | Biliary Tract Diseases |
| D005705 | Gallbladder Diseases |
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