NCT01320241

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Southeast University, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholangiocellular Carcinoma
• Pancreatic Cancer
• Gallbladder Cancer
• Metastatic Carcinoma

Interventions

Type	Name	Description
DEVICE	self-expandable 125I radioactive seeds-loaded-stent	Patients undergo placement of a self-expandable 125I radioactive seeds-loaded-stent on day 1.
DEVICE	self-expandable biliary nitinol alloys stent	Patients undergo placement of a conventional self-expandable biliary nitinol alloys stent on day 1.

Timeline

• Start date: 2008-11-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-03-22
• Last updated: 2012-04-02

Locations

1 site across 1 country: China