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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

Tracking Information
First Submitted Date  ICMJE April 30, 2012
First Posted Date  ICMJE May 3, 2012
Results First Submitted Date  ICMJE September 18, 2017
Results First Posted Date  ICMJE October 17, 2017
Last Update Posted Date October 17, 2017
Study Start Date  ICMJE September 2012
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2012)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2012)
16 Fr plastic 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 ]
Change History Complete list of historical versions of study NCT01590394 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Patency of a Prototype Large Plastic Biliary Stent in the Palliation of Malignant Distal Biliary Strictures.
Official Title  ICMJE Prospective Evaluation of Luminal Patency of a Prototype Large Plastic Biliary Stent in the Palliation of Malignant Distal Biliary Strictures.
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stricture
  • Obstruction
  • Cancer
Intervention  ICMJE Device: Large plastic biliary stent
Stent placement for bile duct obstruction.
Study Arms  ICMJE Experimental: Pancreatic Cancer Patients
A large plastic biliary stent was placed in the bile duct.
Intervention: Device: Large plastic biliary stent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 12, 2016)
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2012)
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01590394
Other Study ID Numbers  ICMJE 11-003154
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christopher J. Gostout, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Olympus America, Inc.
Investigators  ICMJE
Principal Investigator: Christopher J Gostout, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP