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

Phase 2CompletedNCT01320241

Southeast University, China24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cholangiocellular Carcinoma Pancreatic Cancer Gallbladder Cancer

Interventions

self-expandable 125I radioactive seeds-loaded-stentDEVICE

Patients undergo placement of a self-expandable 125I radioactive seeds-loaded-stent on day 1.

self-expandable biliary nitinol alloys stentDEVICE

Patients undergo placement of a conventional self-expandable biliary nitinol alloys stent on day 1.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall Mean Survival and Median Survival

Time frame: follow-up in interval of stent insertion and death (3 years)

Secondary Outcomes

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.