Combined Stent Insertion and HIFU Ablation for Pancreatic Carcinoma With Biliary Obstruction
NCT ID: NCT03962478
Last Updated: 2020-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
92 participants
INTERVENTIONAL
2019-05-31
2020-09-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stent with high-intensity focused ultrasound ablation
Patients undergo stent insertion with high-intensity focused ultrasound ablation on day 1.
biliary stent and high-intensity focused ultrasound ablation system
Self-expandable biliary nitinol alloys stent and YDME FEP-BY02 high-intensity focused ultrasound equipment
Stent without high-intensity focused ultrasound ablation
Patients undergo stent insertion on day 1.
biliary stent
Self-expandable biliary nitinol alloys stent
Interventions
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biliary stent and high-intensity focused ultrasound ablation system
Self-expandable biliary nitinol alloys stent and YDME FEP-BY02 high-intensity focused ultrasound equipment
biliary stent
Self-expandable biliary nitinol alloys stent
Eligibility Criteria
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Inclusion Criteria
2. pathologically diagnosed pancreatic carcinoma;
3. unresectable cases.
Exclusion Criteria
2. Eastern Cooperative Oncology Group performance status of 4;
3. life expectancy of 3 months or less;
4. biliary obstruction that was not directly caused by pancreatic carcinoma.
18 Years
80 Years
ALL
No
Sponsors
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Xuzhou Central Hospital
OTHER
Responsible Party
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Principal Investigators
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Chi Cao, MD
Role: PRINCIPAL_INVESTIGATOR
Xuzhou Central Hospital
Locations
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Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Countries
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References
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Niu S, Cheng L, Qiao Y, Fu YF, Cao C. Combined Stent Insertion and High-intensity Focused Ultrasound Ablation for Patients With Malignant Obstructive Jaundice. Surg Laparosc Endosc Percutan Tech. 2016 Dec;26(6):488-492. doi: 10.1097/SLE.0000000000000327.
Zhang FQ, Li L, Huang PC, Xia FF, Zhu L, Cao C. Stent Insertion With High Intensity-Focused Ultrasound Ablation for Biliary Obstruction Caused by Pancreatic Carcinoma: A Randomized Controlled Trial. Surg Laparosc Endosc Percutan Tech. 2021 Feb 17;31(3):298-303. doi: 10.1097/SLE.0000000000000918.
Other Identifiers
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20190522-021
Identifier Type: -
Identifier Source: org_study_id
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