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

NCT01590394 | Terminated Results

• 1 other identifier: 11-003154
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Stricture; Obstruction; Cancer

Keywords

obstruction; bile duct; malignant

Outcome Measures

Primary Outcomes (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.

  6 months

Study Arms (1)

Pancreatic Cancer Patients

EXPERIMENTAL

A large plastic biliary stent was placed in the bile duct.

Device: Large plastic biliary stent

Interventions

Large plastic biliary stent DEVICE

Stent placement for bile duct obstruction.

Pancreatic Cancer Patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Olympus America, Inc.: collaborator

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Constriction, Pathologic; Bites and Stings; Neoplasms

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Limitations and Caveats

The study was terminated early due to difficulty in enrolling subjects and transporting the scope for sterilization.

Results Point of Contact

• Title: Christopher J. Gostout
• Organization: Mayo Clinic

gostout.christopher@mayo.edu

507-284-7647

Study Officials

• Christopher J Gostout, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 3, 2012
• Study Start: September 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 17, 2017
• Results First Posted: October 17, 2017

Record last verified: 2017-09

Locations

US (1)