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

Southeast University, China

Status and phase: Completed; Phase 2

Conditions: Gallbladder Cancer; Cholangiocellular Carcinoma; Metastatic Carcinoma; Pancreatic Cancer

Treatments: Device: self-expandable biliary nitinol alloys stent; Device: self-expandable 125I radioactive seeds-loaded-stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01320241

320924197612177170-BS

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

novel radiation stent

Active Comparator group

Description:

Patients undergo placement of a novel biliary stent loaded with 125I seeds on day 1. Intervention: Device: self-expandable 125I radioactive seeds-loaded-stent

Treatment:

Device: self-expandable 125I radioactive seeds-loaded-stent

conventional stent

Experimental group

Description:

Patients undergo placement of a conventional nitinol SEMS on day1. Intervention: Device: self-expandable biliary nitinol alloys stent

Treatment:

Device: self-expandable biliary nitinol alloys stent