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

This study is currently recruiting participants.
Verified January 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Christopher J. Gostout, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01590394
First received: April 30, 2012
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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 Intervention
Stricture
Obstruction
Cancer
Device: Large plastic biliary stent

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Large plastic stents
A large plastic biliary stent will be placed in the bile duct.
Device: Large plastic biliary stent
Stent placement for bile duct obstruction.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. (appendix A)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590394

Locations
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Todd H Baron, MD    507-254-2511    baron.todd@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Todd H Baron, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Christopher J. Gostout, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01590394     History of Changes
Other Study ID Numbers: 11-003154
Study First Received: April 30, 2012
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
obstruction
bile duct
malignant

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 22, 2014