Combined Stent Insertion and HIFU Ablation for Pancreatic Carcinoma With Biliary Obstruction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Combined Stent Insertion and High-intensity Focused Ultrasound Ablation for Pancreatic Carcinoma With Biliary Obstruction

Conditions
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Pancreatic Carcinoma, Biliary Obstruction

Intervention / Treatment
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* Device: biliary stent and high-intensity focused ultrasound ablation system
* Device: biliary stent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stent with high-intensity focused ultrasound ablation<br>Patients undergo stent insertion with high-intensity focused ultrasound ablation on day 1. | Device: biliary stent and high-intensity focused ultrasound ablation system<br>* Self-expandable biliary nitinol alloys stent and YDME FEP-BY02 high-intensity focused ultrasound equipment<br>|
| Active Comparator: Stent without high-intensity focused ultrasound ablation<br>Patients undergo stent insertion on day 1. | Device: biliary stent<br>* Self-expandable biliary nitinol alloys stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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. |