Patency of a Prototype Large Plastic Biliary Stent in the Palliation of Malignant Distal Biliary Strictures.
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 11-003154
NCT ID: NCT01590394
Sponsor Protocol Number: 11-003154
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
- 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. (appendix A)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Christopher Gostout, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available