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

Phase 2

Completed

• Conditions: Cholangiocellular Carcinoma; Pancreatic Cancer; Gallbladder Cancer; Metastatic Carcinoma
• Interventions: Device: self-expandable 125I radioactive seeds-loaded-stent; Device: self-expandable biliary nitinol alloys stent

• Registration Number: NCT01320241
• Lead Sponsor: Southeast University, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Status Verified: 2011-03
• Study First Submitted: 2011-03-21
• Study First Submitted QC: 2011-03-21
• Study First Posted: 2011-03-22
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-30
• Last Update Posted: 2012-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
novel radiation stent	self-expandable 125I radioactive seeds-loaded-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
conventional stent	self-expandable biliary nitinol alloys stent	Patients undergo placement of a conventional nitinol SEMS on day1. Intervention: Device: self-expandable biliary nitinol alloys stent

Primary Outcome Measures

Name	Time	Method
Overall Mean Survival and Median Survival	follow-up in interval of stent insertion and death (3 years)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Zhongda Hospital,Southeast University; 🇨🇳 Nanjing, Jiangsu, China