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Radiation Stent Versus Self-expanding Metallic Stents (SEMS) for Palliative Treatment of Malignant Biliary Stricture

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gao-Jun Teng, Southeast University, China
ClinicalTrials.gov Identifier:
NCT01320241
First received: March 21, 2011
Last updated: March 30, 2012
Last verified: March 2011
History of Changes

March 21, 2011
March 30, 2012
November 2008
March 2012   (final data collection date for primary outcome measure)
Overall Mean Survival and Median Survival [ Time Frame: follow-up in interval of stent insertion and death (3 years) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01320241 on ClinicalTrials.gov Archive Site
Number of Participants with Adverse Events as a Measure of Technical Success, Clinical Success, Safety (including WBC and Immunological changes of lab, Leakage of the radioactive seeds and Complications related to the procedure. [ Time Frame: follow-up in interval of stent insertion and death (3 years) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Radiation Stent Versus Self-expanding Metallic Stents (SEMS) for Palliative Treatment of Malignant Biliary Stricture
An Unicentric RCT About Novel Radiation Stent Versus Nitinol SEMS for Palliative Treatment of Malignant Biliary Stricture

Malignant biliary obstruction is a common clinical condition caused by various malignancies. Currently,biliary stent implantation guided either by fluoroscopy or endoscopy has become the most important methods for relieving malignant biliary obstruction. However, the benefit for the survival of the patients with palliation of the stent treatment is limited because no therapeutic effects on process of the tumor itself by a stent implantation. Encouraged by the success of 125I esophageal stent in esophageal carcinoma, a novel biliary stent loaded with 125I radioactive seeds has been developed in our institute. After ex vivo and in vivo evaluations for the delivery system, the investigators prospectively compare the responses to treatment with this radiation biliary stent, versus the conventional biliary SEMS in patient with malignant biliary obstruction.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Cholangiocellular Carcinoma
  • Pancreatic Cancer
  • Gallbladder Cancer
  • Metastatic Carcinoma
  • Device: self-expandable 125I radioactive seeds-loaded-stent
    Patients undergo placement of a self-expandable 125I radioactive seeds-loaded-stent on day 1.
    Other Name: irradiation biliary stent
  • Device: self-expandable biliary nitinol alloys stent
    Patients undergo placement of a conventional self-expandable biliary nitinol alloys stent on day 1.
    Other Name: conventional SEMS
  • Active Comparator: novel radiation stent

    Patients undergo placement of a novel biliary stent loaded with 125I seeds on day 1.

    Intervention: Device: self-expandable 125I radioactive seeds-loaded-stent

    Intervention: Device: self-expandable 125I radioactive seeds-loaded-stent
  • Experimental: conventional stent

    Patients undergo placement of a conventional nitinol SEMS on day1.

    Intervention: Device: self-expandable biliary nitinol alloys stent

    Intervention: Device: self-expandable biliary nitinol alloys stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years old or older
  • Biliary obstruction by any malignant process with histologically or cytologically confirmed by biopsy or previous surgical procedures
  • Clinical symptoms of biliary obstruction
  • Unresectable or refused to be surgically treated biliary obstruction by any malignant process
  • Willing and able to comply with the study procedures and provide written informed consent to participate in the study

Exclusion Criteria:

  • Suspected benign bile duct stricture
  • Strictures that can not be dilated enough to pass the delivery system
  • Perforation of any duct within the biliary tree
  • Presence metallic biliary stent or bile duct surgery
  • Patients for whom PTC procedures are contraindicated
  • Patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver
  • Noncooperation or no authorization and signature
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01320241
320924197612177170-BS
Yes
Gao-Jun Teng, Southeast University, China
Southeast University, China
Not Provided
Principal Investigator: Gao-jun Teng, MD, PhD Zhong-Da Hospital, Southeast University
Southeast University, China
March 2011

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