The purpose of this randomized controlled study is to evaluate the efficacy and safety of the Radiation-Emitting Metallic Stents (REMS) combined with Trans-Arterial Infusion (TAI) for unresectable hilar cholangiocarcinoma.
This is a multicentric, open-labal, randomized controlled trial which aims to evaluate the efficacy and safety of Radiation-Emitting Metallic Stents (REMS) combined with Trans-Arterial Infusion (TAI) versus Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma. The primary hypotheses are that Radiation-Emitting Metallic Stents (REMS) combined with Trans-Arterial Infusion (TAI) is superior to Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) with respect to Over survival(OS). The primary endpoint is overall survival. The secondary endpoints include quality of life, progression free survival, relief of jaundice, patency, and adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Zhongda Hospital,Southeast University
Nanjing, Jiangsu, China
Overall survival
Time from treatment to the day when the patients died or lost to the follow-up.
Time frame: Participants will be followed till die or lost to follow-up, an expected average of a year.
Quality of life assessed by Quality-of-life Questionnaire Core 30
Quality of life was assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (QLQ-C30), which was completed at different time points: baseline (T0), 4 weeks (T1), 12 weeks (T2), and 24 weeks (T3) after stenting procedures.
Time frame: 24 weeks
Time to symptom progression
Symptom progression was defined as when ECOG performance status increased from 0-2 before enrollment to 4 or 5
Time frame: Participants will be followed till progression appeared or die or lost to follow-up, an expected average of a year.
Patency
Time from stent placement to the day when re-stenosis of the stent occurred.
Time frame: Participants will be followed till die or lost to follow-up, an expected average of a year.
Adverse events
Including side effect/complication, radioactive safety. Complications would be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE 4.03).
Time frame: Participants will be followed till die or lost to follow-up, an expected average of a year.
Relief of jaundice
Relief of jaundice was defined as reduction of more than 20% total bilirubin within 1 week after stent implantation.
Time frame: Relief of jaundice was evaluated within 1 week after stent implantation.
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