Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

September 10, 2014 updated by: yan liu, 307 Hospital of PLA

Intraluminal Implantation of Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

The purpose of this study is to determine whether radioactive stents and common used plastic stents are effective and safety in the treatment of unresectable biliary tract cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients with unresectable biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, or ampullary carcinoma) were enrolled and placed with a stent loaded with radioactive seeds (irradiation stent group) or a conventional plastic stent (traditional stent group). After stent placement, the outcomes were compared in terms of tumor response, progression-free survival, overall survival time, and complications related to the procedures.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

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
    • Beijing
      • Beijing, Beijing, China, 10086
        • Recruiting
        • 307 Hospital of PLA
        • Contact:
          • Zhaoshen Li, Doctor
        • Sub-Investigator:
          • Min Min, M.D. PhD.

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:

  • Patients were eligible if they had received a histopathological or cytologic diagnosis of nonresectable, recurrent, or metastatic biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma,or ampullary carcinoma)
  • Patients aged between 18 and 80 years
  • an estimated life expectancy of more than 3 months
  • Disease had to be measurable by computed tomography scan (as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria
  • TNM stage III-IV
  • no evidence of cancer of another organ.
  • no prior chemotherapy for advanced disease was allowed, but adjuvant/neoadjuvant therapy was allowed
  • Karnofsky index of ≥60%
  • ECOG index ≥2
  • previous technically successful stenting or ENBD derange
  • Accept of informed consent

Exclusion Criteria:

  • Clinically significant cardiovascular disease
  • coagulation disorders
  • contraindication of Endoscopic
  • pregnant or breastfeeding women
  • known sensitivity sensitivity to investigated agents or components
  • recent invasive procedure
  • prior chemotherapy or radiotherapy for biliary cancer
  • refusal of informed consent

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: radioactive stent
The radioactive stent carrying seeds iodine 125 is made of Polytetrafluoroethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the irradiation group patients.
Device: radioactive stent
radioactive stent carrying seed iodine 125
Other Names:
  • brand names: carriable radioactive bile duct plastic stent
  • serial numbers and code name: PBS1-A/B-10/160/140
Other: plastic stent
The plastic stent is made of polyethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the conventional group patients.
Device: plastic stent
common plastic stent without carrying seed iodine 125

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Response rate
Time Frame: 3 months
The investigators will conduct CT test or MRI scan after the implantation of the stents in order to measure the tumor size of each patients and evaluate the best tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.0).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 6 months
In order to research the progression-free survival, the investigators will check the presence of progression disease for each patients until the date of disease progression or death.
6 months
overall survival
Time Frame: follow-up in interval of stent insertion and death (1 years)
Overall survival was calculated from the date of randomization until the date of death.
follow-up in interval of stent insertion and death (1 years)
Adverse events
Time Frame: 1 year
Individual adverse events
1 year

Collaborators and Investigators

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

Sponsor

307 Hospital of PLA

Collaborators

Changhai Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

  • Principal Investigator: Yan Liu, Doctor, 307 hospital of PLA, Beijing, China

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

August 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

September 10, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Estimate)

September 12, 2014

Last Update Submitted That Met QC Criteria

September 10, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yanliu307
  • 307xhk (Other Grant/Funding Number: National Natural Science Foundation of China)

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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