Combined Stent Insertion and HIFU Ablation for Pancreatic Carcinoma With Biliary Obstruction (HIFU)
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|ClinicalTrials.gov Identifier: NCT03962478|
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : June 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Carcinoma Biliary Obstruction||Device: biliary stent and high-intensity focused ultrasound ablation system Device: biliary stent||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combined Stent Insertion and High-intensity Focused Ultrasound Ablation for Pancreatic Carcinoma With Biliary Obstruction|
|Actual Study Start Date :||May 31, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: Stent with high-intensity focused ultrasound ablation
Patients undergo stent insertion with high-intensity focused ultrasound ablation on day 1.
Device: biliary stent and high-intensity focused ultrasound ablation system
Self-expandable biliary nitinol alloys stent and YDME FEP-BY02 high-intensity focused ultrasound equipment
Active Comparator: Stent without high-intensity focused ultrasound ablation
Patients undergo stent insertion on day 1.
Device: biliary stent
Self-expandable biliary nitinol alloys stent
- 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.
- Stent patency [ Time Frame: From the date of randomization until the date of first documented stent dysfunction, assessed up to 10 months ]Stent dysfunction is suspected when the patient experiences recurrence of jaundice.
- Stent dysfunction free survival [ Time Frame: 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. ]From the date of randomization until the date of first documented stent dysfunction or the date of death from any cause, whichever came first.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962478
|Contact: Chi Cao, MDemail@example.com|
|Contact: Yu-Fei Fu, MDfirstname.lastname@example.org|
|Xuzhou Central Hospital||Recruiting|
|Xuzhou, Jiangsu, China, 221009|
|Contact: Chi Cao, MD +8618952171195 email@example.com|
|Principal Investigator:||Chi Cao, MD||Xuzhou Central Hospital|