Obstructive Jaundice, Pancreatic Cancer
Conditions
Keywords
pancreatic cancer, obstructive jaundice, Obstructive jaundice secondary to pancreatic cancer
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREMetal stent
Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent.
PROCEDUREPlastic stent
Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a 10Fr plastic stent.
Sponsors
University of Virginia
AdventHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients with pancreatic cancer and mass in the head of pancreas causing jaundice. * Patients 19 yrs of age and older * Serum bilirubin \> 2mg/dl * CT: No evidence of distant metastasis or local vascular invasion (tumor surrounding portal or mesenteric vessels for more than 180 degrees of their circumference or an irregular vessel margin).
Exclusion criteria
* Karnofsky score \< 60 * Prior (ERCP or PTC) attempts at biliary decompression for the same indication * Tumor-related gastric outlet obstruction (vomiting and oral intake of \< 1L/day) * Ongoing or planned neoadjuvant therapy * Cholangitis at presentation or coagulopathy needing reversal medication * Post-surgical anatomy * Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum * Failed ERCP's (Definition: Inability to deploy a biliary stent thereby requiring a PTC or surgery).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications related to stent dysfunction | 30 days | Complications related to stent dysfunction which include hyperbilirubinemia or cholangitis that warrant stent exchange (repeat intervention by ERCP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural complications | 30 days | Complications related to the procedure which includes pancreatitis, perforation or hemorrhage. |
Countries
United States
Outcome results
None listed