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no subjects were found who met criteria
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The current standard of care for bile duct stone are endoscopic sphincterotomy and stone extraction. Placement of plastic stents is an option for incomplete biliary stone clearance. This study will use the CSEMS in patients with complex biliary stones who failed stone extraction as they have the advantage of large stent diameter. CSEMS may offer a temporizing measure that allows more successful subsequent stone clearance. However, their use in benign condition has been limited especially for biliary stone removal. The purpose of this study is to determine the feasibility, safety, easy removability, stent-stone formation rate, and migration rate of CSEMS for complex biliary stones.
same as brief summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Incomplete biliary stone extraction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERCP with metal stent | Procedure | ERCP will be used so that a metal stent can be placed to facilitate the removal of the biliary stone |
|
| Measure | Description | Time Frame |
|---|---|---|
| complete biliary stone clearance | This is an observational study where the ERCP being done is part of the standard of care for choledocholithiasis. There are no study interventions | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| other techniques used for stone clearance | This will include the number of ERCP's needed to achive the complete biliary stone clearance, Use of mechanical Lithotripsy, use of cholangioscopy, procedure duration and any adverse events safety | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Those patients who have a biliary stone that has not been removed by standard medical care.
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| Name | Affiliation | Role |
|---|---|---|
| Peter V Draganov, MD | University of Florida | Principal Investigator |
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| ID | Term |
|---|---|
| D042883 | Choledocholithiasis |
| ID | Term |
|---|---|
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
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|
| D002769 | Cholelithiasis |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |