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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
  Purpose

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.


Condition Intervention Phase
Cholangiocellular Carcinoma
Pancreatic Cancer
Gallbladder Cancer
Metastatic Carcinoma
 Device: self-expandable 125I radioactive seeds-loaded-stent
Device: self-expandable biliary nitinol alloys stent
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: An Unicentric RCT About Novel Radiation Stent Versus Nitinol SEMS for Palliative Treatment of Malignant Biliary Stricture

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southeast University, China:

Primary Outcome Measures:
  • Overall Mean Survival and Median Survival [ Time Frame: follow-up in interval of stent insertion and death (3 years) ] [ Designated as safety issue: No ]

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. [ Time Frame: follow-up in interval of stent insertion and death (3 years) ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: November 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: conventional SEMS

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320241

Locations
China, Jiangsu
Zhongda Hospital,Southeast University
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Southeast University, China
Investigators
Principal Investigator: Gao-jun Teng, MD, PhD Zhong-Da Hospital, Southeast University
  More Information

No publications provided

Responsible Party: Gao-Jun Teng, Director of Department of Radiology, Southeast University, China
ClinicalTrials.gov Identifier: NCT01320241     History of Changes
Other Study ID Numbers: 320924197612177170-BS
Study First Received: March 21, 2011
Last Updated: March 30, 2012
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Carcinoma
Pancreatic Neoplasms
Gallbladder Neoplasms
Cholangiocarcinoma
Cholestasis
Constriction, Pathologic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases
Adenocarcinoma
Bile Duct Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 21, 2013