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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320241
• Other study ID #: 320924197612177170-BS
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2011
• Last updated: March 30, 2012
• Start date: November 2008
• Est. completion date: March 2012

Study information

• Verified date: March 2011
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Cholangiocarcinoma
• Cholangiocellular Carcinoma
• Gallbladder Cancer
• Metastatic Carcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Device:
• self-expandable 125I radioactive seeds-loaded-stent
Patients undergo placement of a self-expandable 125I radioactive seeds-loaded-stent on day 1.
• self-expandable biliary nitinol alloys stent
Patients undergo placement of a conventional self-expandable biliary nitinol alloys stent on day 1.

Locations

Country	Name	City	State
China	Zhongda Hospital,Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Mean Survival and Median Survival		follow-up in interval of stent insertion and death (3 years)	No
Secondary	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)	Yes