Cholangiocellular Carcinoma, Gallbladder Cancer, Metastatic Carcinoma, Pancreatic Cancer
Conditions
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.
Interventions
DEVICEself-expandable 125I radioactive seeds-loaded-stent
Patients undergo placement of a self-expandable 125I radioactive seeds-loaded-stent on day 1.
DEVICEself-expandable biliary nitinol alloys stent
Patients undergo placement of a conventional self-expandable biliary nitinol alloys stent on day 1.
Sponsors
Southeast University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Mean Survival and Median Survival | follow-up in interval of stent insertion and death (3 years) |
Secondary
| 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. | follow-up in interval of stent insertion and death (3 years) |
Countries
China
Outcome results
None listed