TerminatedNot Applicable

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

Stopped: Difficulty in enrolling subjects and transporting scope for sterilization

United States3 participantsStarted 2012-09

Plain-language summary

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.

Who can participate

Age range18 Years – 85 Years

SexALL

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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

Exclusion criteria

✕. 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

What they're measuring

Large Plastic Biliary Stents Will Have a Longer Patency Time Than Conventionally Used 10 Fr Stents in Subjects as Compared to Well-known Published Historical Control Data.

Timeframe: 6 months

Trial details

NCT IDNCT01590394

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-04

Results submitted2017-09-18

View on ClinicalTrials.gov More Stricture trials