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| Name | Class |
|---|---|
| Vanderbilt University | OTHER |
| University of Maryland, Baltimore | OTHER |
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Compare the performance of full covered metal stents and plastic stents for preoperative biliary decompression
Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr plastic stents. When compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for CSEMS. The investigators hypothesize that placement of CSEMS would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metal stent | Active Comparator | Patients randomized to one cohort will undergo placement of fully covered self expandable metal stents. The rates (%) of stent dysfunction and complications will be evaluated. |
|
| Plastic Stent | Active Comparator | At ERCP, a 10Fr plastic stent will be placed in the bile duct. The rates (%) of stent dysfunction and complications will be evaluated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent Dysfunction | Procedure | Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complications related to stent dysfunction | Evaluate the rates of complications (%) related to stent dysfunction which include persistent hyperbilirubinemia and cholangitis that warrant stent exchange by a repeat ERCP. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural complications | This will be measured as proportion of patients who encounter a procedural complication (%) during ERCP that includes pancreatitis, perforation or hemorrhage. | 30 days |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| shyam varadarajulu, MD | Florida Hospital Center for Interventional Endoscopy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Hospital | Orlando | Florida | 32814 | United States |
A manuscript will be developed following completion of the study.
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| ID | Term |
|---|---|
| D041781 | Jaundice, Obstructive |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D007565 | Jaundice |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Complications | Procedure | Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed. |
|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |