Cancer Clinical Trial
Official title:
Prospective Evaluation of Luminal Patency of a Prototype Large Plastic Biliary Stent in the Palliation of Malignant Distal Biliary Strictures.
Verified date | September 2017 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: Inclusion Criteria: 1. = 18 and = 85 years of age 2. Malignant biliary obstruction, known or suspected 3. Increased bilirubin or jaundice or history thereof 4. Duct stricture (obstruction) = 1 cm distal to the biliary hilum (bifurcation of the common hepatic duct into the right and left hepatic ducts) 5. Not an operative candidate Exclusion Criteria: 1. Unable to obtain consent 2. Unable to tolerate endoscopic procedure 3. Suspected non-malignant bile duct stricture 4. Candidate for potentially curative surgical intervention 5. Previous SEMS 6. Previous bile duct surgery 7. Diffuse liver metastasis 8. Peritoneal metastasis by CT 9. Presence of ascites 10. Duodenal obstruction preventing passage of the duodenoscope to the level of the papilla 11. Failure to cannulate bile duct during ERCP 12. Karnofsky performance score < 40 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | Olympus America, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 months |
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