Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction

Completed · Not applicable

Conditions studied: Pancreatic Cancer

In brief

This is a single center, randomized, unblinded study to compare the rate of occlusion of plastic, uncovered metal, or fully covered metal biliary stents in patient's with surgically resectable disease or those undergoing neoadjuvant chemoradiotherapy. We will also compare occlusion rates between uncovered metal and fully covered metal biliary stents in those patients determined to have surgically unresectable disease.

Key facts

Study ID

NCT01038713

Run by

Dartmouth-Hitchcock Medical Center

People needed

94

Starts

2009-12-01

Expected to finish

2013-12-01

Last updated by the study team

2016-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female older than 18
• Capable of providing written informed consent
• Presenting with malignant biliary obstruction requiring biliary drainage either from proximal pancreatic malignancy, metastatic disease, or intrinsic biliary malignancy. The patient must have an established diagnosis of underlying malignancy, and surgical resectability status established, prior to enrollment in this study.

You may not qualify if…

• Inability to undergo conscious sedation or monitored anesthesia
• Prior pancreatico-biliary surgery
• Evidence of acute cholecystitis at time of endoscopic procedure
• Intraluminal filling defect requiring endoscopic removal prior to stent placement
• Inability to provide written informed consent
• Malignancy not verified prior to stent placement

Where it is running

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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