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

Overview

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:

  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. (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

More about research at Mayo Clinic

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CLS-20143415

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