Patency of a Prototype Large Plastic Biliary Stent in the Palliation of Malignant Distal Biliary Strictures.

Stopped early · Not applicable

Conditions studied: Stricture, Obstruction, Cancer

In brief

Plastic biliary stents which are a new larger size will remain free of obstructions for a longer period of time than currently used 10 French stents in cancer in the common bile duct.

Key facts

Study ID

NCT01590394

Run by

Mayo Clinic

People needed

3

Starts

2012-09-01

Expected to finish

2016-04-01

Last updated by the study team

2017-10-17

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria:
• ≥ 18 and ≤ 85 years of age
• Malignant biliary obstruction, known or suspected
• Increased bilirubin or jaundice or history thereof
• Duct stricture (obstruction) ≥ 1 cm distal to the biliary hilum (bifurcation of the common hepatic duct into the right and left hepatic ducts)
• Not an operative candidate

You may not qualify if…

• Unable to obtain consent
• Unable to tolerate endoscopic procedure
• Suspected non-malignant bile duct stricture
• Candidate for potentially curative surgical intervention
• Previous SEMS
• Previous bile duct surgery
• Diffuse liver metastasis
• Peritoneal metastasis by CT
• Presence of ascites
• Duodenal obstruction preventing passage of the duodenoscope to the level of the papilla
• Failure to cannulate bile duct during ERCP
• Karnofsky performance score < 40

Where it is running

• Mayo Clinic Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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