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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-03-31

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.

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Detailed Description

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Conditions

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Cholangiocellular Carcinoma Pancreatic Cancer Gallbladder Cancer Metastatic Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

self-expandable 125I radioactive seeds-loaded-stent

Intervention Type DEVICE

Patients undergo placement of a self-expandable 125I radioactive seeds-loaded-stent on day 1.

conventional stent

Patients undergo placement of a conventional nitinol SEMS on day1.

Intervention: Device: self-expandable biliary nitinol alloys stent

Group Type EXPERIMENTAL

self-expandable biliary nitinol alloys stent

Intervention Type DEVICE

Patients undergo placement of a conventional self-expandable biliary nitinol alloys stent on day 1.

Interventions

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self-expandable 125I radioactive seeds-loaded-stent

Patients undergo placement of a self-expandable 125I radioactive seeds-loaded-stent on day 1.

Intervention Type DEVICE

self-expandable biliary nitinol alloys stent

Patients undergo placement of a conventional self-expandable biliary nitinol alloys stent on day 1.

Intervention Type DEVICE

Other Intervention Names

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irradiation biliary stent conventional SEMS

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No