Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

307 Hospital of PLA

Status: Unknown

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

Treatments: Device: plastic stent; Device: radioactive stent

Study type: Interventional

Funder types: Other

Identifiers

NCT02238613

307xhk (Other Grant/Funding Number)

yanliu307

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

radioactive stent

Experimental group

Description:

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.

Treatment:

Device: radioactive stent

plastic stent

Other group

Description:

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.

Treatment:

Device: plastic stent