Clinical trial NCT01320241: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cholangiocellular Carcinoma
Pancreatic Cancer
Gallbladder Cancer
Metastatic Carcinoma
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall Mean Survival and Median Survival
timeFrame: follow-up in interval of stent insertion and death (3 years)
Secondary outcomes:
measure: 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.
timeFrame: follow-up in interval of stent insertion and death (3 years)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital,Southeast University
state: Jiangsu
Study officials:
affiliation: Zhong-Da Hospital, Southeast University
name: Gao-jun Teng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: