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| Name | Class |
|---|---|
| University of Virginia | OTHER |
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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.
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 as there will be better drainage of the obstructed biliary system with fewer adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metal stent | Active Comparator | Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent. |
|
| Plastic Stent | Active Comparator | Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a plastic stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metal stent | Procedure | Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complications related to stent dysfunction | Complications related to stent dysfunction which include hyperbilirubinemia or cholangitis that warrant stent exchange (repeat intervention by ERCP) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural complications | Complications related to the procedure which includes pancreatitis, perforation or hemorrhage. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad Hasan, MD | AdventHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth | Orlando | Florida | 32814 | United States |
A manuscript will be developed following the closure 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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| ID | Term |
|---|---|
| D000069322 | Self Expandable Metallic Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Plastic stent | Procedure | Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a 10Fr plastic stent. |
|
| 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 |