Combined Stent Insertion and High-intensity Focused Ultrasound Ablation for Pancreatic Carcinoma With Biliary Obstruction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Carcinoma
- Sponsor
- Xuzhou Central Hospital
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- 6-month survival rate
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with pancreatic carcinoma and biliary obstruction who are treated by stent insertion with or without high-intensity focused ultrasound ablation.
Detailed Description
Distal malignant biliary obstruction is a common problem in patients with pancreatic carcinoma. In unresectable pancreatic carcinomas, percutaneous stent placement has been pivotal in providing relief from obstructive jaundice, improving the quality of life, and allowing the maintenance of anticancer treatment. Venous chemotherapy, transcatheter arterial chemoembolization, or radiotherapy have been used to prolong stent patency and survival after stent insertion for patients with pancreatic carcinoma and biliary obstruction. High-intensity focused ultrasound ablation is a noninvasive and atoxic treatment of malignant tumor using focused ultrasound energy from an extracorporeal source that is targeted within the body resulting in thermally induced necrosis and apoptosis. The purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with pancreatic carcinoma and biliary obstruction who are treated by stent insertion with or without high-intensity focused ultrasound ablation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •malignant distal biliary obstruction;
- •pathologically diagnosed pancreatic carcinoma;
- •unresectable cases.
Exclusion Criteria
- •inability to obtain informed consent;
- •Eastern Cooperative Oncology Group performance status of 4;
- •life expectancy of 3 months or less;
- •biliary obstruction that was not directly caused by pancreatic carcinoma.
Outcomes
Primary Outcomes
6-month survival rate
Time Frame: From the date of randomization until the date of first documented death from any cause, assessed up to 12 months
From the date of randomization until the date of first documented death from any cause.
Secondary Outcomes
- Stent patency(From the date of randomization until the date of first documented stent dysfunction, assessed up to 10 months)
- Stent dysfunction free survival(From the date of randomization until the date of first documented stent dysfunction or the date of death from any cause, whichever came first, assessed up to 10 months.)