Safety and Efficacy of EUS-RFA in the Treatment of Pancreatic Lesions: A Prospective Registry
NCT ID: NCT07136324
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
100 participants
OBSERVATIONAL
2018-10-30
2028-07-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
EUS-guided RFA treatment
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.
Interventions
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EUS-guided RFA treatment
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Patients unable to provide informed consent
3. Patients unable to complete follow-up
18 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Nirav C Thosani
Associate Professor
Principal Investigators
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Nirav C Thosani, MD, MHA
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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Memorial Hermann Hospital
Houston, Texas, United States
Countries
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References
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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.
Ierardi 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.
Evrard 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.
Haen 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.
Goldberg SN. Radiofrequency tumor ablation: principles and techniques. Eur J Ultrasound. 2001 Jun;13(2):129-47. doi: 10.1016/s0929-8266(01)00126-4.
Yoon 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.
Winter 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.
Vincent 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.
Other Identifiers
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HSC-MS-18-0192
Identifier Type: -
Identifier Source: org_study_id
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