Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

307 Hospital of PLA140 enrolled

Overview

The purpose of this study is to determine whether radioactive stents and common used plastic stents are effective and safety in the treatment of unresectable biliary tract cancer.

Patients with unresectable biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, or ampullary carcinoma) were enrolled and placed with a stent loaded with radioactive seeds (irradiation stent group) or a conventional plastic stent (traditional stent group). After stent placement, the outcomes were compared in terms of tumor response, progression-free survival, overall survival time, and complications related to the procedures.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Intrahepatic Cholangiocarcinoma Cholangiocarcinoma of the Extrahepatic Bile Duct Ampullary Carcinoma Biliary Obstruction

Interventions

radioactive stentDEVICE

radioactive stent carrying seed iodine 125

plastic stentDEVICE

common plastic stent without carrying seed iodine 125

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients were eligible if they had received a histopathological or cytologic diagnosis of nonresectable, recurrent, or metastatic biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma,or ampullary carcinoma) * Patients aged between 18 and 80 years * an estimated life expectancy of more than 3 months * Disease had to be measurable by computed tomography scan (as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria * TNM stage III-IV * no evidence of cancer of another organ. * no prior chemotherapy for advanced disease was allowed, but adjuvant/neoadjuvant therapy was allowed * Karnofsky index of ≥60% * ECOG index ≥2 * previous technically successful stenting or ENBD derange * Accept of informed consent Exclusion Criteria: * Clinically significant cardiovascular disease * coagulation disorders * contraindication of Endoscopic * pregnant or breastfeeding women * known sensitivity sensitivity to investigated agents or components * recent invasive procedure * prior chemotherapy or radiotherapy for biliary cancer * refusal of informed consent

Locations (1)

307 hospital of PLA

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Tumor Response rate

The investigators will conduct CT test or MRI scan after the implantation of the stents in order to measure the tumor size of each patients and evaluate the best tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.0).

Time frame: 3 months

Secondary Outcomes

Progression-free survival

In order to research the progression-free survival, the investigators will check the presence of progression disease for each patients until the date of disease progression or death.

Time frame: 6 months

overall survival

Overall survival was calculated from the date of randomization until the date of death.

Time frame: follow-up in interval of stent insertion and death (1 years)

Adverse events

Individual adverse events

Time frame: 1 year

Central Contacts

Yan Liu, MD,PhD

CONTACT

86-13911798288 13911798288@163.com

Data from ClinicalTrials.gov

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