Clinical trial NCT02238613: Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer
Official title: Intraluminal Implantation of Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrahepatic Cholangiocarcinoma
Cholangiocarcinoma of the Extrahepatic Bile Duct
Ampullary Carcinoma
Biliary Obstruction
Keywords: Radioactive stents
Brachytherapy
Biliary obstruction
Intrahepatic Cholangiocarcinoma
Cholangiocarcinoma of the Extrahepatic Bile Duct
ampullary carcinoma
Lead sponsor: 307 Hospital of PLA
Sponsor class: OTHER
Collaborators: name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Changhai Hospital
First posted: 2014-09-12
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tumor Response rate
timeFrame: 3 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: 6 months
measure: overall survival
timeFrame: follow-up in interval of stent insertion and death (1 years)
measure: Adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: 307 hospital of PLA
state: Beijing
Study officials:
affiliation: 307 hospital of PLA, Beijing, China
name: Yan Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: