Pancreatic CystNCT07136324
Safety and Efficacy of EUS-RFA in the Treatment of Pancreatic Lesions: A Prospective Registry
An observational study of Pancreatic Cyst, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Purpose: The purpose of this registry is to track the clinical outcomes and progression of patients with pancreatic lesions receiving endoscopic ultrasound (EUS)-based radiofrequency ablation (RFA) therapy. Research Design: This study is a 7-year, single-center prospective registry study with annual follow up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cyst
- What is being tested?
- EUS-guided RFA treatment
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2018to 1 Jul 2028
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who are undergoing EUS-RFA for the treatment of their pancreatic lesion(s).
Who may be able to join
- 1. Diagnosis of any pancreatic premalignant lesion and/or pancreatic malignancy
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.
About this study
Official title: Safety and Efficacy of Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) in the Treatment of Pancreatic Lesions: A Prospective Registry
Purpose: The purpose of this registry is to track the clinical outcomes and progression of patients with pancreatic lesions receiving endoscopic ultrasound (EUS)-based radiofrequency ablation (RFA) therapy.
Research Design: This study is a 7-year, single-center prospective registry study with annual follow up. Patients with pancreatic lesions undergoing EUS-guided RFA treatment will be studied. There will be no deviation from standard of care procedures.
Read more
Procedures to be Used: Following recruitment into the program, eligible patients will undergo EUS-RFA for the treatment of their pancreatic lesion and/or malignancy as part of their standard of care.
Endoscopic Intervention: The EUS-guided intervention will be performed based on a clinical decision. The data will be collected for research purposes. Briefly, the procedure involves advancing a 19-gauge EUS-RFA catheter into the target lesion under EUS-guidance. RFA energy is then applied in 2-10 cycles with each cycle lasting about 10 to 30 seconds and the power setting ranging from 10 to 30 Watts. The same physician who performs the initial EUS-RFA procedure will be responsible for subsequent EUS-RFA procedures.
Risks and Potential Benefits: This is a minimal-risk study with associated physical risks being those part of routine standard of care. Additional risks associated with this study include the possible loss of confidentiality if the patient data or information is inadvertently disclosed outside of this study, risks associated with obtaining blood samples, and risks associated with obtaining tissue samples via biopsy. However, all information will be kept strictly confidential and will be used only for research purposes by the listed investigators. Patients will not receive any additional benefit from the study aside from those received as part of standard of care.
- Conditions
- Pancreatic Cyst
- Being tested
- EUS-guided RFA treatment
- Medical subject headings
- Pancreatic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided RFA treatmentDevice
A 19-gauge EUS-RFA catheter will be inserted into pancreatic lesions under EUS guidance. RFA energy is then applied in 2-10 cycles with each cycle lasting about 10-30 seconds and the power setting ranging from 10-30 Watts.
| Study group | Role | What they receive |
|---|---|---|
| Patients with pancreatic lesions | Patients with pancreatic lesions undergoing EUS-guided RFA treatment. Patients of either gender that are 18 years of age or older. Receives: Device: EUS-guided RFA treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success of EUS-RFA Defined as Complete Ablation of Target Pancreatic Lesions on Imaging
The efficacy of EUS-RFA in inducing the remission of functional, pre-malignant, and/or malignant solid/cystic pancreatic lesions.
Measured: From the date of patients' index EUS-RFA procedure to the end of their follow-up period at 3 years.
Secondary outcomes (3)
Post-procedure complications observed within 30 days
This will be measured based on the grade of the adverse event (ranging from grade 1 (mild) to grade 5 (death). Some notable adverse events include any deaths, life-threatening complications, congenital anomalies, complications that require intervention to prevent permanent impairment/damage, and hospitalization.
Measured: From the date of patients' EUS-RFA procedure to 30 days following the procedure.
Change in Tumor Size Assessed by Cross-Sectional Imaging
Cross-sectional imaging will be used to assess pancreatic lesion size following EUS-RFA. Tumor length, width, and height will be measured in centimeters. For lesions with cystic components, the maximum cyst diameter in centimeters will also be measured. Change in tumor size will be evaluated from baseline to follow-up.
Measured: From the date of patients' index EUS-RFA procedure to the end of their follow-up period at 3 years.
Change in Serum Tumor Marker Concentrations Following EUS-RFA
Clinically indicated serum tumor marker assays, including CEA, CA 19-9, CA 125, CD40, TNF-α, and CD40L, will be measured at baseline and during follow-up. Change in tumor marker concentrations will be evaluated over the study period.
Measured: From the date of patients' index EUS-RFA procedure to the end of their follow-up period at 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start30 Oct 2018
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CystStudies 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
- 100 participants (actual)
- 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 C Thosani, MD, MHA, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136324
- Sponsor's protocol ID
- HSC-MS-18-0192
- Status last verified
- May 2026
- First submitted
- 8 Jan 2021
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Varshney S, Sewkani A, Sharma S, Kapoor S, Naik S, Sharma A, Patel K. Radiofrequency ablation of unresectable pancreatic carcinoma: feasibility, efficacy and safety. JOP. 2006 Jan 11;7(1):74-8.
PubMed 16407624Ierardi AM, Lucchina N, Bacuzzi A, Marco de C, Bracchi E, Cocozza E, Dionigi G, Tsetis D, Floridi C, Carrafiello G. Percutaneous ablation therapies of inoperable pancreatic cancer: a systematic review. Ann Gastroenterol. 2015 Oct-Dec;28(4):431-9.
PubMed 26424487Evrard S, Menetrier-Caux C, Biota C, Neaud V, Mathoulin-Pelissier S, Blay JY, Rosenbaum J. Cytokines pattern after surgical radiofrequency ablation of liver colorectal metastases. Gastroenterol Clin Biol. 2007 Feb;31(2):141-5. doi: 10.1016/s0399-8320(07)89344-4.
PubMed 17347620Haen SP, Pereira PL, Salih HR, Rammensee HG, Gouttefangeas C. More than just tumor destruction: immunomodulation by thermal ablation of cancer. Clin Dev Immunol. 2011;2011:160250. doi: 10.1155/2011/160250. Epub 2011 Dec 29.
PubMed 22242035Goldberg SN. Radiofrequency tumor ablation: principles and techniques. Eur J Ultrasound. 2001 Jun;13(2):129-47. doi: 10.1016/s0929-8266(01)00126-4.
PubMed 11369525Yoon WJ, Brugge WR. Endoscopic ultrasonography-guided tumor ablation. Gastrointest Endosc Clin N Am. 2012 Apr;22(2):359-69, xi. doi: 10.1016/j.giec.2012.04.017.
PubMed 22632957Winter JM, Cameron JL, Campbell KA, Arnold MA, Chang DC, Coleman J, Hodgin MB, Sauter PK, Hruban RH, Riall TS, Schulick RD, Choti MA, Lillemoe KD, Yeo CJ. 1423 pancreaticoduodenectomies for pancreatic cancer: A single-institution experience. J Gastrointest Surg. 2006 Nov;10(9):1199-210; discussion 1210-1. doi: 10.1016/j.gassur.2006.08.018.
PubMed 17114007Vincent A, Herman J, Schulick R, Hruban RH, Goggins M. Pancreatic cancer. Lancet. 2011 Aug 13;378(9791):607-20. doi: 10.1016/S0140-6736(10)62307-0. Epub 2011 May 26.
PubMed 21620466
Study at a glance
From the registry record, last updated by the sponsor on 12 May 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 Prospective Registry
- ClinicalTrials.gov ID
- NCT07136324
- Acronym / sponsor ID
- HSC-MS-18-0192
- Conditions
- Pancreatic Cyst
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 22 Aug 2025 (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.
Purpose: The purpose of this registry is to track the clinical outcomes and progression of patients with pancreatic lesions receiving endoscopic ultrasound (EUS)-based radiofrequency ablation (RFA) therapy.
Research Design: This study is a 7-year, single-center prospective registry study with annual follow up. Patients with pancreatic lesions undergoing EUS-guided RFA treatment will be studied. There will be no deviation from standard of care procedures.
Procedures to be Used: Following recruitment into the program, eligible patients will undergo EUS-RFA for the treatment of their pancreatic lesion and/or malignancy as part of their standard of care.
Endoscopic Intervention: The EUS-guided intervention will be performed based on a clinical decision. The data will be collected for research purposes. Briefly, the procedure involves advancing a 19-gauge EUS-RFA catheter into the target lesion under EUS-guidance. RFA energy is then applied in 2-10 cycles with each cycle lasting about 10 to 30 seconds and the power setting ranging from 10 to 30 Watts. The same physician who performs the initial EUS-RFA procedure will be responsible for subsequent EUS-RFA procedures.
Risks and Potential Benefits: This is a minimal-risk study with associated physical risks being those part of routine standard of care. Additional risks associated with this study include the possible loss of confidentiality if the patient data or information is inadvertently disclosed outside of this study, risks associated with obtaining blood samples, and risks associated with obtaining tissue samples via biopsy. However, all information will be kept strictly confidential and will be used only for research purposes by the listed investigators. Patients will not receive any additional benefit from the study aside from those received as part of standard of care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pancreatic lesions | – | Device: EUS-guided RFA treatmentPatients with pancreatic lesions undergoing EUS-guided RFA treatment. Patients of either gender that are 18 years of age or older. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who are undergoing EUS-RFA for the treatment of their pancreatic lesion(s).
Key inclusion criteria (1 listed)
- 1. Diagnosis of any pancreatic premalignant lesion and/or pancreatic malignancy
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 |
|---|---|---|
| EUS-guided RFA treatmentA 19-gauge EUS-RFA catheter will be inserted into pancreatic lesions under EUS guidance. RFA energy is then applied in 2-10 cycles with each cycle lasting about 10-30 seconds and the power setting ranging from 10-30 Watts. | Device | Patients with pancreatic lesions |
Primary outcome
Technical Success of EUS-RFA Defined as Complete Ablation of Target Pancreatic Lesions on Imaging
Time frame: From the date of patients' index EUS-RFA procedure to the end of their follow-up period at 3 years.
The efficacy of EUS-RFA in inducing the remission of functional, pre-malignant, and/or malignant solid/cystic pancreatic lesions.
3 secondary outcomes
Post-procedure complications observed within 30 days
Time frame: From the date of patients' EUS-RFA procedure to 30 days following the procedure.
Change in Tumor Size Assessed by Cross-Sectional Imaging
Time frame: From the date of patients' index EUS-RFA procedure to the end of their follow-up period at 3 years.
Change in Serum Tumor Marker Concentrations Following EUS-RFA
Time frame: From the date of patients' index EUS-RFA procedure to the end of their follow-up period at 3 years.
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 12 May 2026.
- Background: PubMed 16407624Varshney S, Sewkani A, Sharma S, Kapoor S, Naik S, Sharma A, Patel K. Radiofrequency ablation of unresectable pancreatic carcinoma: feasibility, efficacy and safety. JOP. 2006 Jan 11;7(1):74-8.
- Background: PubMed 26424487Ierardi AM, Lucchina N, Bacuzzi A, Marco de C, Bracchi E, Cocozza E, Dionigi G, Tsetis D, Floridi C, Carrafiello G. Percutaneous ablation therapies of inoperable pancreatic cancer: a systematic review. Ann Gastroenterol. 2015 Oct-Dec;28(4):431-9.
- Background: PubMed 17347620Evrard S, Menetrier-Caux C, Biota C, Neaud V, Mathoulin-Pelissier S, Blay JY, Rosenbaum J. Cytokines pattern after surgical radiofrequency ablation of liver colorectal metastases. Gastroenterol Clin Biol. 2007 Feb;31(2):141-5. doi: 10.1016/s0399-8320(07)89344-4.
- Background: PubMed 22242035Haen SP, Pereira PL, Salih HR, Rammensee HG, Gouttefangeas C. More than just tumor destruction: immunomodulation by thermal ablation of cancer. Clin Dev Immunol. 2011;2011:160250. doi: 10.1155/2011/160250. Epub 2011 Dec 29.
- Background: PubMed 11369525Goldberg SN. Radiofrequency tumor ablation: principles and techniques. Eur J Ultrasound. 2001 Jun;13(2):129-47. doi: 10.1016/s0929-8266(01)00126-4.
- Background: PubMed 22632957Yoon WJ, Brugge WR. Endoscopic ultrasonography-guided tumor ablation. Gastrointest Endosc Clin N Am. 2012 Apr;22(2):359-69, xi. doi: 10.1016/j.giec.2012.04.017.
- Background: PubMed 17114007Winter JM, Cameron JL, Campbell KA, Arnold MA, Chang DC, Coleman J, Hodgin MB, Sauter PK, Hruban RH, Riall TS, Schulick RD, Choti MA, Lillemoe KD, Yeo CJ. 1423 pancreaticoduodenectomies for pancreatic cancer: A single-institution experience. J Gastrointest Surg. 2006 Nov;10(9):1199-210; discussion 1210-1. doi: 10.1016/j.gassur.2006.08.018.
- Background: PubMed 21620466Vincent A, Herman J, Schulick R, Hruban RH, Goggins M. Pancreatic cancer. Lancet. 2011 Aug 13;378(9791):607-20. doi: 10.1016/S0140-6736(10)62307-0. Epub 2011 May 26.
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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.
Nirav C Thosani, MD, MHA principal investigator
The University of Texas Health Science Center, 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 Cyst, 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 1 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: under way, not looking for participants, as of the sponsor's last update on 12 May 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?
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?
Technical Success of EUS-RFA Defined as Complete Ablation of Target Pancreatic Lesions on Imaging (time frame: From the date of patients' index EUS-RFA procedure to the end of their follow-up period at 3 years.). 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 NCT07136324, which also lists 8 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 12 May 2026.