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

Study Overview
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Brief Summary
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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.

Official Title
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An Unicentric RCT About Novel Radiation Stent Versus Nitinol SEMS for Palliative Treatment of Malignant Biliary Stricture

Conditions
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Cholangiocellular Carcinoma, Pancreatic Cancer, Gallbladder Cancer, Metastatic Carcinoma

Intervention / Treatment
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* Device: self-expandable 125I radioactive seeds-loaded-stent
* Device: self-expandable biliary nitinol alloys stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: novel radiation stent<br>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<br>* Patients undergo placement of a self-expandable 125I radioactive seeds-loaded-stent on day 1.<br>* Other names: irradiation biliary stent;|
| Experimental: conventional stent<br>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<br>* Patients undergo placement of a conventional self-expandable biliary nitinol alloys stent on day 1.<br>* Other names: conventional SEMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Mean Survival and Median Survival |  | follow-up in interval of stent insertion and death (3 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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) |