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2019-05-31
2020-02-08
2020-09-28
92
NCT03962478
Xuzhou Central Hospital
Xuzhou Central Hospital
INTERVENTIONAL
Combined Stent Insertion and HIFU Ablation for Pancreatic Carcinoma With Biliary Obstruction
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-05-22 | N/A | 2020-09-28 |
2019-05-22 | N/A | 2020-09-30 |
2019-05-24 | N/A | 2020-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| 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
|
| ACTIVE_COMPARATOR: Stent without high-intensity focused ultrasound ablation Patients undergo stent insertion on day 1. | DEVICE: biliary stent
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 6-month survival rate | From the date of randomization until the date of first documented death from any cause. | From the date of randomization until the date of first documented death from any cause, assessed up to 12 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Stent patency | Stent dysfunction is suspected when the patient experiences recurrence of jaundice. | 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. | 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. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
