Pancreatic CancerNCT07737171
Safety and Efficacy of Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) in the Treatment of Pancreatic Lesions
An observational study of Pancreatic Cancer, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This is a 7-year prospective single-center registry study to assess the safety and efficacy of Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) in the treatment of pancreatic lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA)
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2026to 1 Apr 2033
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: Population is recruited from the PI's and Co-I's daily clinic
Who may be able to join
- Diagnosis of any pancreatic pre-malignant lesion and/or pancreatic malignancy
- Patients already undergoing EUS-RFA for treatment of pancreatic lesions clinically
Who cannot join
- Patients with co-existing malignancies of other organs (or a prior history of such)
- Patients unable to provide informed consent
- Patients unable to complete follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Amatullah Alibhai, MBA, 713-500-6658, Amatullah.Alibhai@uth.tmc.edu
Nicole Fatheree, BBA, 713-500-5669, Nicole.Fatheree@uth.tmc.edu
About this study
Official title: Safety and Efficacy of Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) in the Treatment of Pancreatic Lesions: A Pancardinal-4 Prospective Registry
This is a 7-year prospective single-center registry study to assess the safety and efficacy of Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) in the treatment of pancreatic lesions.
- Conditions
- Pancreatic Cancer
- Being tested
- Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA)
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA)Device
EUS-guided Radiofrequency Ablation (RFA) consists of the application of alternating current with a frequency of 350-500 kHz (coincidentally the frequency range of radio broadcasts as well) to the target tissue via a special electrode located at the tip of the endoscope.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients who undergo EUS-RFA for treatment of pancreatic lesions | Not described Receives: Device: Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants for whom there is technical success of tumor treatment
Technical success of tumor treatment is defined as successful delivery of EUS-guided radiofrequency ablation (RFA) energy to the target pancreatic lesion with:
- Accurate placement of the RFA probe within the intended lesion under EUS guidance
- Completion of the planned ablation cycles
- Immediate post-ablation sonographic evidence of treatment effect (e.g., hyperechoic changes within lesion indicating coagulative necrosis)
Measured: From time of the procedure to about 3 months post procedure
Secondary outcomes (3)
Number of participants with post-procedure complications observed within 30 days
Post-procedure complications will be defined and graded using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
Complications will include but are not limited to:
- Pancreatitis
- Bleeding
- Death
Measured: from the time of the procedure to 30 days after the procedure
Reduction in the size of the tumor
Tumor size will be measured using cross-sectional imaging (contrast-enhanced CT or MRI preferred). When clinically indicated, endoscopic ultrasound (EUS) measurements may also be recorded.
Measured: baseline, 3 months, 6 months, 3 years
Reduction in systemic tumor markers
The following serum markers will be collected:
- CA 19-9
- CEA
- Lipase
- Amylase
The following plasma biomarkers will be collected:
- IL-18
- ICAM-1
- CXCL12
- CD40
- CD40L
- TNF-α
Measured: baseline, at the time of the first RFA (about 1 month after baseline), at the time of the second RFA (about 2 months after baseline), at the time of the third RFA (about 3 month after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start7 Apr 2026
- Primary completion1 Apr 2033 (estimated)
- Study completion1 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nirav C Thosani, The University of Texas Health Science Center, Houston
- Investigators
- Nirav Thosani, MD, Principal investigator, The University of Texas Health Science Center at Houston (UTHealth Houston)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737171
- Sponsor's protocol ID
- HSC-MS-24-1077
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) in the Treatment of Pancreatic Lesions: A Pancardinal-4 Prospective Registry
- ClinicalTrials.gov ID
- NCT07737171
- Acronym / sponsor ID
- HSC-MS-24-1077
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 1 Apr 2033 (estimated)
- Study completion
- 1 Apr 2033 (estimated)
- First posted
- 30 Jul 2026 (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.
This is a 7-year prospective single-center registry study to assess the safety and efficacy of Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) in the treatment of pancreatic lesions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients who undergo EUS-RFA for treatment of pancreatic lesions | – | Device: Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Population is recruited from the PI's and Co-I's daily clinic
Key inclusion criteria (2 listed)
- Diagnosis of any pancreatic pre-malignant lesion and/or pancreatic malignancy
- Patients already undergoing EUS-RFA for treatment of pancreatic lesions clinically
Key exclusion criteria (3 listed)
- Patients with co-existing malignancies of other organs (or a prior history of such)
- Patients unable to provide informed consent
- Patients unable to complete follow-up
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 |
|---|---|---|
| Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA)EUS-guided Radiofrequency Ablation (RFA) consists of the application of alternating current with a frequency of 350-500 kHz (coincidentally the frequency range of radio broadcasts as well) to the target tissue via a special electrode located at the tip of the endoscope. | Device | Adult patients who undergo EUS-RFA for treatment of pancreatic lesions |
Primary outcome
Number of participants for whom there is technical success of tumor treatment
Time frame: From time of the procedure to about 3 months post procedure
Technical success of tumor treatment is defined as successful delivery of EUS-guided radiofrequency ablation (RFA) energy to the target pancreatic lesion with: * Accurate placement of the RFA probe within the intended lesion under EUS guidance * Completion of the planned ablation cycles * Immediate post-ablation sonographic evidence of treatment effect (e.g., hyperechoic changes within lesion indicating coagulative necrosis)
3 secondary outcomes
Number of participants with post-procedure complications observed within 30 days
Time frame: from the time of the procedure to 30 days after the procedure
Reduction in the size of the tumor
Time frame: baseline, 3 months, 6 months, 3 years
Reduction in systemic tumor markers
Time frame: baseline, at the time of the first RFA (about 1 month after baseline), at the time of the second RFA (about 2 months after baseline), at the time of the third RFA (about 3 month after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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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.
Nirav Thosani, MD principal investigator
The University of Texas Health Science Center at Houston (UTHealth Houston)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Jul 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amatullah Alibhai, MBA (713-500-6658, Amatullah.Alibhai@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants for whom there is technical success of tumor treatment (time frame: From time of the procedure to about 3 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2026.