Safety and Efficacy of EUS-RFA in the Treatment of Pancreatic Lesions: A Prospective Registry

NCT07136324 | Active Not Recruiting FDA Device

• 1 other identifier: HSC-MS-18-0192
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Pancreatic Cyst

Outcome Measures

Primary Outcomes (1)

• Technical success of the tumor treatment

  The efficacy of EUS-RFA in inducing the remission of functional, pre-malignant, and/or malignant solid/cystic pancreatic lesions.

  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

  From the date of patients' EUS-RFA procedure to 30 days following the procedure.

• Reduction in the size of the tumor

  From the date of patients' index EUS-RFA procedure to the end of their follow-up period at 3 years.

• Reduction in systemic tumor markers

  From the date of patients' index EUS-RFA procedure to the end of their follow-up period at 3 years.

Study Arms (1)

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.

Device: EUS-guided RFA treatment

Interventions

EUS-guided RFA treatment DEVICE

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.

Patients with pancreatic lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who are undergoing EUS-RFA for the treatment of their pancreatic lesion(s).

You may qualify if:

• \. Diagnosis of any pancreatic premalignant lesion and/or pancreatic malignancy

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77054, United States

Location

Related Publications (8)

• 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.

  PMID: 16407624 BACKGROUND

• 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.

  PMID: 26424487 BACKGROUND

• 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.

  PMID: 17347620 BACKGROUND

• 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.

  PMID: 22242035 BACKGROUND

• 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.

  PMID: 11369525 BACKGROUND

• 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.

  PMID: 22632957 BACKGROUND

• 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.

  PMID: 17114007 BACKGROUND

• 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.

  PMID: 21620466 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and fixed tissues samples (biopsy tissue samples embedded in paraffin).

MeSH Terms

Conditions

Pancreatic Cyst

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Nirav C Thosani, MD, MHA

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: August 22, 2025
• Study Start: October 30, 2018
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

US (1)