Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

Sponsor

307 Hospital of PLA (Other)

Overall Status

Unknown status

CT.gov ID

NCT02238613

Collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other), Changhai Hospital (Other)

140

Enrollment

Location

Arms

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intrahepatic Cholangiocarcinoma Cholangiocarcinoma of the Extrahepatic Bile Duct Ampullary Carcinoma Biliary Obstruction	Device: radioactive stent Device: plastic stent	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2014

Anticipated Primary Completion Date :

Jun 1, 2016

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: radioactive stent radioactive stent carrying seed iodine 125 Other Names: brand names: carriable radioactive bile duct plastic stent serial numbers and code name: PBS1-A/B-10/160/140
Other: 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.	Device: plastic stent common plastic stent without carrying seed iodine 125

Arm

Intervention/Treatment

Experimental: 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.

Device: radioactive stent

radioactive stent carrying seed iodine 125

Other Names:

brand names: carriable radioactive bile duct plastic stent

serial numbers and code name: PBS1-A/B-10/160/140

Other: 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.

Device: plastic stent

common plastic stent without carrying seed iodine 125

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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