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

NCT01320241 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-04-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Southeast University, China

    lead OTHER

Principal Investigators

  • Gao-jun Teng, MD, PhD · Zhong-Da Hospital, Southeast University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01320241 on ClinicalTrials.gov