Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Cholangiocarcinoma

Biliary Tract Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Bile Duct Cancer

Biliary Tract Cancer

Intrahepatic Cholangiocarcinoma

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Iodine

Cadexomer iodine

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.

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.

radioactive stent carrying seed iodine 125

radioactive stent

common plastic stent without carrying seed iodine 125

plastic stent

Yan Liu, MD,PhD

Zhaoshen Li, Doctor

Min Min, M.D. PhD.

Yan Liu, Doctor

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.

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.

Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

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

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).

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 was calculated from the date of randomization until the date of death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer	NCT02238613	Intrahepatic Ch... Cholangiocarcin... Ampullary Carci... Biliary Obstruc...	radioactive ste... plastic stent	18 Years - 80 Years	307 Hospital of PLA
Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer	NCT02238613	Intrahepatic Ch... Cholangiocarcin... Ampullary Carci... Biliary Obstruc...	radioactive ste... plastic stent	18 Years - 80 Years	307 Hospital of PLA

Spots Global Cancer Trial Database for radioactive stents