Clinical trial · Observational
Safety and Efficacy of EUS-RFA in the Treatment of Pancreatic Lesions: A Prospective Registry
Safety and Efficacy of Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) in the Treatment of Pancreatic Lesions: A Prospective Registry
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cyst | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS-guided RFA treatment | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with pancreatic lesions
- description
- Patients with pancreatic lesions undergoing EUS-guided RFA treatment. Patients of either gender that are 18 years of age or older.
- interventionNames
- Device: EUS-guided RFA treatment
Primary outcomes (1)
- measure
- Technical Success of EUS-RFA Defined as Complete Ablation of Target Pancreatic Lesions on Imaging
- timeFrame
- From the date of patients' index EUS-RFA procedure to the end of their follow-up period at 3 years.
- description
- The efficacy of EUS-RFA in inducing the remission of functional, pre-malignant, and/or malignant solid/cystic pancreatic lesions.
Secondary outcomes (3)
- measure
- Post-procedure complications observed within 30 days
- timeFrame
- From the date of patients' EUS-RFA procedure to 30 days following the procedure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1\. Diagnosis of any pancreatic premalignant lesion and/or pancreatic malignancy Exclusion Criteria: 1. Patients with co-existing malignancies of other organs (or a prior history of such) 2. Patients unable to provide informed consent 3. Patients unable to complete follow-up
References
Publications (8)
- BACKGROUNDVarshney 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. PMID 16407624
- BACKGROUNDIerardi 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. PMID 26424487
- BACKGROUNDEvrard 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. PMID 17347620
- BACKGROUNDHaen 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. PMID 22242035
- BACKGROUNDGoldberg SN. Radiofrequency tumor ablation: principles and techniques. Eur J Ultrasound. 2001 Jun;13(2):129-47. doi: 10.1016/s0929-8266(01)00126-4. PMID 11369525
- BACKGROUNDYoon 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. PMID 22632957
- BACKGROUNDWinter 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. PMID 17114007