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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01191814
Other study ID # FT356090
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2010
Est. completion date October 13, 2022

Study information

Verified date July 2023
Source AdventHealth
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date October 13, 2022
Est. primary completion date October 13, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years to 85 Years
Eligibility 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).

Study Design


Intervention

Procedure:
Metal stent
Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent.
Plastic stent
Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a 10Fr plastic stent.

Locations

Country Name City State
United States AdventHealth Orlando Florida

Sponsors (2)

Lead Sponsor Collaborator
AdventHealth University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Procedural complications Complications related to the procedure which includes pancreatitis, perforation or hemorrhage. 30 days
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