Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

Not Applicable

• Conditions: Cholangiocarcinoma of the Extrahepatic Bile Duct; Intrahepatic Cholangiocarcinoma; Ampullary Carcinoma; Biliary Obstruction
• Interventions: Device: radioactive stent; Device: plastic stent

• Registration Number: NCT02238613
• Lead Sponsor: 307 Hospital of PLA

Brief Summary

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

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 Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-25
• Status Verified: 2014-09
• Study First Submitted QC: 2014-09-10
• Last Update Submitted: 2014-09-10
• Study First Posted: 2014-09-12
• Last Update Posted: 2014-09-12
• Primary Completion: 2016-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
radioactive stent	radioactive stent	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.
plastic stent	plastic stent	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.

Primary Outcome Measures

Name	Time	Method
Tumor Response rate	3 months	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).

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	6 months	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.
overall survival	follow-up in interval of stent insertion and death (1 years)	Overall survival was calculated from the date of randomization until the date of death.
Adverse events	1 year	Individual adverse events

Trial Locations

Locations (1)

307 hospital of PLA; 🇨🇳 Beijing, Beijing, China