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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01590394
Recruitment Status : Terminated (Difficulty in enrolling subjects and transporting scope for sterilization)
First Posted : May 3, 2012
Results First Posted : October 17, 2017
Last Update Posted : October 17, 2017
Olympus America, Inc.
Information provided by (Responsible Party):
Christopher J. Gostout, Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Stricture Obstruction Cancer Device: Large plastic biliary stent Not Applicable

Detailed Description:

Malignant obstruction of the extra-hepatic bile duct often leads to jaundice and pruritus and occasionally results in cholangitis and bacteremia. Pancreatic cancer accounts for a large proportion of patients presenting with malignant extra-hepatic biliary obstruction. Most pancreatic cancers are unresectable at presentation, and palliation, including biliary decompression, is often a goal of therapy. Over the last decade, biliary decompression with endoscopically-placed stents during endoscopic retrograde cholangiopancreatography (ERCP) has largely replaced surgical bilioenteric diversion. Biliary decompression via endoscopic stenting alleviates cholestatic symptoms and improves quality of life. When compared to surgery, endoscopically placed plastic stents result in decreased morbidity and a trend towards decreased 30 day mortality. However, surgery is associated with a lower risk of recurrent biliary obstruction.

Stent diameter is an important factor in determining duration of biliary luminal patency. All plastic biliary stents will ultimately occlude due to deposition of bacterial biofilm. The original plastic biliary stents were 7 French (Fr) in diameter, with a patency rate of about 4 weeks. With increases in the size of the working channel of duodenoscopes, the limiting factor in what diameter stent can be deployed, 10 Fr stents were developed, with patency rates of approximately 15 weeks (3-4 months). Until recently, the largest stent that could be deployed with the current endoscopic technology using a conventional duodenoscope of acceptable outer diameter was 11.5 Fr; the limited available data suggest that these stents do not offer more prolonged luminal patency interval compared to 10 Fr stents.

In the early 1990s, self-expandable metal stents (SEMS) became available for use in palliation of malignant biliary obstruction. Once deployed, SEMS achieve larger diameters than plastic stents, which results in a longer median patency interval of approximately six to eight months.[3, 6, 9-12] Although effective, metal stents are eight to ten times more costly than plastic stents.

Recently, a large working channel duodenoscope with an acceptable outer diameter has been developed. This prototype duodenoscope allows passage of larger stents, which the investigators have successfully placed in select cases using this prototype. This duodenoscope, manufactured by Olympus Medical Systems Corp., is FDA approved.

The investigators hypothesize that, with the substantially increased luminal diameter, larger plastic stents will provide more prolonged relief of obstructive jaundice in patients with malignant distal common bile duct strictures. If this proves to be true, larger plastic stents may constitute a cost-effective alternative to SEMS, especially in health care systems that cannot afford SEMS.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Luminal Patency of a Prototype Large Plastic Biliary Stent in the Palliation of Malignant Distal Biliary Strictures.
Study Start Date : September 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: Pancreatic Cancer Patients
A large plastic biliary stent was placed in the bile duct.
Device: Large plastic biliary stent
Stent placement for bile duct obstruction.

Primary Outcome Measures :
  1. 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. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01590394

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United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Olympus America, Inc.
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Principal Investigator: Christopher J Gostout, MD Mayo Clinic

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Responsible Party: Christopher J. Gostout, MD, Mayo Clinic Identifier: NCT01590394    
Other Study ID Numbers: 11-003154
First Posted: May 3, 2012    Key Record Dates
Results First Posted: October 17, 2017
Last Update Posted: October 17, 2017
Last Verified: September 2017
Keywords provided by Christopher J. Gostout, Mayo Clinic:
bile duct
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical