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

March 30, 2012 updated by: Gao-Jun Teng, Southeast University, China

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Zhongda Hospital，Southeast University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Device: self-expandable 125I radioactive seeds-loaded-stent
Patients undergo placement of a self-expandable 125I radioactive seeds-loaded-stent on day 1.
Other Names:
  • irradiation biliary stent
Experimental: conventional stent

Patients undergo placement of a conventional nitinol SEMS on day1.

Intervention: Device: self-expandable biliary nitinol alloys stent
Device: self-expandable biliary nitinol alloys stent
Patients undergo placement of a conventional self-expandable biliary nitinol alloys stent on day 1.
Other Names:
  • conventional SEMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Mean Survival and Median Survival
Time Frame: follow-up in interval of stent insertion and death (3 years)
follow-up in interval of stent insertion and death (3 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
follow-up in interval of stent insertion and death (3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Investigators

  • Principal Investigator: Gao-jun Teng, MD, PhD, Zhong-da Hospital, Southeast University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

March 21, 2011

First Submitted That Met QC Criteria

March 21, 2011

First Posted (Estimate)

March 22, 2011

Study Record Updates

Last Update Posted (Estimate)

April 2, 2012

Last Update Submitted That Met QC Criteria

March 30, 2012

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 320924197612177170-BS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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