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

Primary Purpose

Cholangiocellular Carcinoma, Pancreatic Cancer, Gallbladder Cancer

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
self-expandable 125I radioactive seeds-loaded-stent
self-expandable biliary nitinol alloys stent
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangiocellular Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongda Hospital,Southeast University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

novel radiation stent

conventional stent

Arm Description

Patients undergo placement of a novel biliary stent loaded with 125I seeds on day 1. Intervention: Device: self-expandable 125I radioactive seeds-loaded-stent

Patients undergo placement of a conventional nitinol SEMS on day1. Intervention: Device: self-expandable biliary nitinol alloys stent

Outcomes

Primary Outcome Measures

Overall Mean Survival and Median Survival

Secondary Outcome Measures

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.

Full Information

First Posted
March 21, 2011
Last Updated
March 30, 2012
Sponsor
Southeast University, China
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1. Study Identification

Unique Protocol Identification Number
NCT01320241
Brief Title
Radiation Stent Versus Self-expanding Metallic Stents (SEMS) for Palliative Treatment of Malignant Biliary Stricture
Official Title
An Unicentric RCT About Novel Radiation Stent Versus Nitinol SEMS for Palliative Treatment of Malignant Biliary Stricture
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocellular Carcinoma, Pancreatic Cancer, Gallbladder Cancer, Metastatic Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
novel radiation stent
Arm Type
Active Comparator
Arm Description
Patients undergo placement of a novel biliary stent loaded with 125I seeds on day 1. Intervention: Device: self-expandable 125I radioactive seeds-loaded-stent
Arm Title
conventional stent
Arm Type
Experimental
Arm Description
Patients undergo placement of a conventional nitinol SEMS on day1. Intervention: Device: self-expandable biliary nitinol alloys stent
Intervention Type
Device
Intervention Name(s)
self-expandable 125I radioactive seeds-loaded-stent
Other Intervention Name(s)
irradiation biliary stent
Intervention Description
Patients undergo placement of a self-expandable 125I radioactive seeds-loaded-stent on day 1.
Intervention Type
Device
Intervention Name(s)
self-expandable biliary nitinol alloys stent
Other Intervention Name(s)
conventional SEMS
Intervention Description
Patients undergo placement of a conventional self-expandable biliary nitinol alloys stent on day 1.
Primary Outcome Measure Information:
Title
Overall Mean Survival and Median Survival
Time Frame
follow-up in interval of stent insertion and death (3 years)
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gao-jun Teng, MD, PhD
Organizational Affiliation
Zhong-Da Hospital, Southeast University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongda Hospital,Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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