Endoscopic Ultrasound-Guided Radiofrequency Ablation for Pancreatic Cystic Neoplasms and Pancreatic Neuroendocrine Tumors

NCT07536087 | Recruiting

• 2 other identifiers: G388NW26J-06-00078
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to evaluate the technical feasibility and effectiveness of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) in the treatment of pancreatic cystic neoplasms (PCNs) and pancreatic neuroendocrine tumors (pNETs) in patients who are not suitable candidates for surgical treatment or who refuse surgery. EUS-RFA, as a minimally invasive therapeutic option, may potentially reduce the need for intensive imaging surveillance, prevent further progression of these lesions, and serve as a bridging therapy in selected patients for whom surgical intervention may be considered in the future. At the same time, EUS-RFA could contribute to reducing overtreatment, thereby lowering the risk of complications associated with surgical procedures and leading to an overall reduction in healthcare costs. The secondary objectives of the study are to evaluate the safety profile of EUS-RFA, including the incidence and severity of adverse events both in the early postoperative period and during the first year of follow-up, as well as to assess the long-term efficacy of EUS-RFA, including disease progression.

Conditions

Endoscopic Ultrasound-Guided Radiofrequency Ablation; Pancreatic Neuroendocrine Tumors (pNET); Pancreatic Cystic Neoplasms

Keywords

Pancreatic Cystic Neoplasm; Intraductal papillary mucinous neoplasm; EUS-guided RFA; Pancreas; Neuroendocrine tumor; Radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• Efficacy of EUS-RFA

  Efficacy will be assessed by the rate of complete resolution, defined as disappearance or radiological evidence of necrosis of the target lesion, or significant response, defined as ≥80% reduction in lesion size on follow-up imaging.

  12 months

Secondary Outcomes (3)

• Safety Profile

  12 months

• Technical Feasibility

  12 months

• Functional Outcomes

  12 months

Study Arms (2)

EUS-guided RFA of pancreatic cystic neoplasms (PCNs)

EXPERIMENTAL

Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) of pancreatic cystic neoplasms in inoperable patients or patients refusing surgery

Procedure: Endoscopic ultrasound-guided radiofrequency ablation for pancreatic cystic lesions

EUS-guided RFA of solid pancreatic lesions

EXPERIMENTAL

Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) of pancreatic solid lesions, including PNET and other non-neuroendocrine solid lesions (e.g., metastases such as renal cell carcinoma)

Procedure: Endoscopic ultrasound-guided radiofrequency ablation of pancreatic solid lesions

Interventions

Endoscopic ultrasound-guided radiofrequency ablation for pancreatic cystic lesions PROCEDURE

All procedures will be performed using a therapeutic linear-array EUS scope. In patients with pancreatic cystic neoplasm, a 19G or 22G needle will be used for cyst puncture and aspiration until only a minimal residual fluid layer remains to facilitate targeting; aspirated fluid may be used for biochemical and cytological analysis. EUS-guided radiofrequency ablation (EUS-RFA) will then be performed using an 18G or 19G internally cooled RFA needle (STARmed, Taewoong) connected to a temperature-controlled generator (VIVA RF). The electrode will be positioned within the cyst under real-time EUS guidance, and radiofrequency energy will be applied according to manufacturer settings (50 W, \~100 Ω). For larger cysts, multiple applications or electrode repositioning may be performed to ensure adequate ablation.

Also known as: EUS-RFA, EUS-guided RFA

EUS-guided RFA of pancreatic cystic neoplasms (PCNs)

Endoscopic ultrasound-guided radiofrequency ablation of pancreatic solid lesions PROCEDURE

All procedures will be performed using a therapeutic linear-array EUS scope. In patients with solid pancreatic lesions, including PNET and non-PNET lesions (e.g., metastases such as renal cell carcinoma), an 18G or 19G internally cooled RFA needle (STARmed, Taewoong) will be advanced into the target lesion under real-time EUS guidance. Radiofrequency energy will be delivered using a temperature-controlled generator (VIVA RF) according to manufacturer settings (50 W, \~100 Ω). The electrode will be positioned within the lesion prior to energy delivery. For larger lesions, multiple applications and/or electrode repositioning will be performed to ensure adequate ablation coverage.

Also known as: EUS-RFA, EUS-guided RFA, EUS-guided RFA of pancreatic solid lesions, EUS-guided RFA of PNET

EUS-guided RFA of solid pancreatic lesions

Eligibility Criteria

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

You may qualify if:

• Consensual indication to EUS-guided RFA treatment made in a multidisciplinary team
• Capability of giving informed consent PCN Inoperability or refusal of surgery
• Branch duct IPMN (BD-IPMN) with worrisome features:
• Jaundice
• High grade dysplasia or cancer
• Solid mass/nodule \> 5mm
• Main pancreatic duct dilation \> 10mm Or at least one (patients without comorbidities) or at least two (patient with comorbidities) of the following risk features:
• CA 19-9\> 37 U/ml
• Increase in size \> 5mm/year
• Dilation of the main pancreatic duct between 5-10mm
• Size ≥ 40mm
• Symptoms (new onset of diabetes, acute pancreatitis)
• Nodule \< 5mm Pancreatic NET
• Size \< 2 cm
• Histological proof in non-functional lesions/histological proof or clinical proof in functional lesions

You may not qualify if:

• Known bleeding disorder that cannot be sufficiently corrected with medication
• Use of anticoagulants that cannot be discontinued
• Physical and/or psychological inability to understand the aims of the research and to adequately cooperate
• Pregnancy
• Inability to sign the informed consent

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Institute for Clinical and Experimental Medicine, Department of Gastroenterology and Hepatology

Prague, 140 21, Czechia

RECRUITING

Related Publications (1)

• 1. Keter D, et al, Acta Gastroenterol Latinoam. 2008;38:146-151, 2. Dumonceau J.M. et at, European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated January 2017. Endoscopy. 2017;49:695-714. 3. Goldberg, S.N. et al, Hepatogastroenterology, 2001. 48(38): p. 359-67, 4. Goldberg, S.N. et al, Eur J Ultrasound, 2001. 13(2): p. 129-47., 5. Gazelle, G.S. et al., Radiology, 2000, 217(3): p. 633-46, 6. Laffan T.A. et al, AJR Am J Roentgenol. 2008 Sep;191(3):802-7, 7. Kromrey M.L. et al, Gut. 2018 Jan;67(1):138-145, 8. Fernández-del Castillo C et al, Arch Surg. 2003 Apr;138(4):427- 3; 9. Grützmann R et al, Oncologist. 2010;15(12):1294-309, 10. Choi SH,. Clin Gastroenterol Hepatol. 2017 Oct;15(10):1509-1520.e4. 11. Lawrence B et al, Endocrinol Metab Clin North Am. 2011 Mar;40(1):111-34, 12. McKenna L.R. et al, Gland Surg 2014;3(4):258-275, 13. Nagtegaal ID et al, Histopathology. 2020 Jan;76(2):182-188, 14. Gomez-Rivera F et al, Am J Surg. 2007;193:460-513, 15. Tanaka, M. et al, Ann Surg Oncol 28, 1614-1624 (2021), 16. Anderson M.A et al, Am. J. Gastroenterol. (2000);95(9): pp. 2,271-2,277. 17. Heidsma CM et al, Br J Surg. 2021 Aug 19;108(8):888-891.18 Ho C.K. et al, HPB (Oxford), 2005;7(2):99-108, 19. Kos-Kudła B et al, J Neuroendocrinol. 2023 Dec;35(12):e13343, 20. Pai M et al, World J Gastrointest Surg. 2015 Apr 27;7(4):52-9, 21.Barthet M. et al, Endoscopy. 2019;51:836-842., 22. Barthet M.et al, Endosc. Int. Open. 2021;9:E1178-E1185., 23. Larghi A et al, Endosc Ultrasound. 2019;8:220-226 , 24. Lakhtakia S et al,Dig Endosc 2017; 29(4): 86- 494. 25 Armellini E et al, Endoscopy 2015; 47(Suppl 1 UCTN): E600-E601. 26. Rossi S et al, Pancreas 2014; 43(6): 938- 945, 27. Lakhtakia S et al, Gastrointest Endosc. 2016 Jan;83(1):234-9, 28 Napoléon B et al, Gastrointest Endosc 2023; 98(3): 392.e1- 399.e1 29 Borrelli de Andreis F et al,Pancreatology 2023; 23(5): 543- 549. 30 Okasha H et al, A Gut 2024; 73: A146-A147

  BACKGROUND

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Central Study Contacts

Jana Jarosova, MD, PhD

CONTACT

420261363282; jana.jarosova@ikem.cz

Gabriela Petranova

CONTACT

420261365154; gabriela.petranova@ikem.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head of Inpatient Ward, Department of Gastroenterology and Hepatology

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 17, 2026
• Study Start: April 11, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

CZ (1)