Pancreatic CarcinomaHIFUNCT03962478
Combined Stent Insertion and HIFU Ablation for Pancreatic Carcinoma With Biliary Obstruction
A study testing biliary stent and high-intensity focused ultrasound ablation system and biliary stent in people with Pancreatic Carcinoma and Biliary Obstruction, run by Xuzhou Central Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Carcinoma, Biliary Obstruction
- What is being tested?
- biliary stent and high-intensity focused ultrasound ablation system and biliary stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2019to 28 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- malignant distal biliary obstruction;
- pathologically diagnosed pancreatic carcinoma;
- unresectable cases.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Stent Insertion and High-intensity Focused Ultrasound 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.
Read the 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.
- Conditions
- Pancreatic Carcinoma, Biliary Obstruction
- Being tested
- biliary stent and high-intensity focused ultrasound ablation system, biliary stent
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biliary stent and high-intensity focused ultrasound ablation systemDevice
Self-expandable biliary nitinol alloys stent and YDME FEP-BY02 high-intensity focused ultrasound equipment
biliary stentDevice
Self-expandable biliary nitinol alloys stent
| Study group | Role | What they receive |
|---|---|---|
| Stent with high-intensity focused ultrasound ablation | Experimental | Patients undergo stent insertion with high-intensity focused ultrasound ablation on day 1. Receives: Device: biliary stent and high-intensity focused ultrasound ablation system |
| Stent without high-intensity focused ultrasound ablation | Active comparator | Patients undergo stent insertion on day 1. Receives: Device: biliary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month survival rate
From the date of randomization until the date of first documented death from any cause.
Measured: From the date of randomization until the date of first documented death from any cause, assessed up to 12 months
Secondary outcomes (2)
Stent patency
Stent dysfunction is suspected when the patient experiences recurrence of jaundice.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start31 May 2019
- Primary completion8 Feb 2020
- Study completion28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuzhou Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi Cao, MD, Principal investigator, Xuzhou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962478
- Sponsor's protocol ID
- 20190522-021
- Acronym
- HIFU
- Status last verified
- Sep 2020
- First submitted
- 22 May 2019
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make individual participant data available.
Publications
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.
PubMed 27783026Zhang 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.
PubMed 33605677
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Stent Insertion and High-intensity Focused Ultrasound Ablation for Pancreatic Carcinoma With Biliary Obstruction
- ClinicalTrials.gov ID
- NCT03962478
- Acronym / sponsor ID
- HIFU / 20190522-021
- Conditions
- Pancreatic Carcinoma, Biliary Obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Xuzhou Central HospitalUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- 8 Feb 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent with high-intensity focused ultrasound ablation | Experimental | Device: biliary stent and high-intensity focused ultrasound ablation systemPatients undergo stent insertion with high-intensity focused ultrasound ablation on day 1. |
| Stent without high-intensity focused ultrasound ablation | Active comparator | Device: biliary stentPatients undergo stent insertion on day 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- malignant distal biliary obstruction;
- pathologically diagnosed pancreatic carcinoma;
- unresectable cases.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biliary stent and high-intensity focused ultrasound ablation systemSelf-expandable biliary nitinol alloys stent and YDME FEP-BY02 high-intensity focused ultrasound equipment | Device | Stent with high-intensity focused ultrasound ablation |
| biliary stentSelf-expandable biliary nitinol alloys stent | Device | Stent without high-intensity focused ultrasound ablation |
Primary outcome
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.
2 secondary outcomes
Stent patency
Time frame: From the date of randomization until the date of first documented stent dysfunction, assessed up to 10 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Background: PubMed 27783026Niu 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.
- Derived from this study: PubMed 33605677Zhang 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.
- Individual participant dataSharing planned: No. There is not a plan to make individual participant data available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Cao, MD principal investigator
Xuzhou Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biliary stent and high-intensity focused ultrasound ablation system and biliary stent in people with Pancreatic Carcinoma and Biliary Obstruction, run by Xuzhou Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03962478, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.