Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intraluminal Implantation of Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

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

Intervention / Treatment
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* Device: radioactive stent
* Device: plastic stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radioactive stent<br>The radioactive stent carrying seeds iodine 125 is made of Polytetrafluoroethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the irradiation group patients. | Device: radioactive stent<br>* radioactive stent carrying seed iodine 125<br>* Other names: serial numbers and code name: PBS1-A/B-10/160/140;|
| Other: plastic stent<br>The plastic stent is made of polyethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the conventional group patients. | Device: plastic stent<br>* common plastic stent without carrying seed iodine 125<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 
| overall survival | Overall survival was calculated from the date of randomization until the date of death. | follow-up in interval of stent insertion and death (1 years) | 
| Adverse events | Individual adverse events | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radioactive stents, Brachytherapy, Biliary obstruction, Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma of the Extrahepatic Bile Duct, ampullary carcinoma