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DOI: 10.1055/a-2778-8145
Endoscopic ultrasound-guided radiofrequency ablation for large branch-duct intraductal papillary mucinous neoplasms: Safety and efficacy trial
Authors
Supported by: National Institute of Health R01CA279965
Clinical Trial:
Registration number (trial ID): NCT05961982, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: Prospective
Abstract
Background and study aims
Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) is a nonsurgical treatment option for managing pancreatic lesions. We sought to evaluate the safety and efficacy of EUS-RFA for large (≥4 cm) branch-duct intraductal papillary mucinous neoplasms (BD-IPMNs).
Patients and methods
Patients with a definitive diagnosis of BD-IPMN who declined or were unfit for surgery underwent EUS-RFA in a single-arm prospective trial. Ablation was performed using a 19G EUS-RFA needle. RFA applications were delivered up to a maximum threshold of 45 seconds or 400 ohms impedance. Safety was assessed using AGREE guidelines. Potential for efficacy was assessed using cyst volume and cyst fluid KRAS GNAS mutations using next-generation sequencing (NGS). Adverse events (AEs) were analyzed per RFA session, while response was analyzed per BD-IPMN.
Results
Thirty BD-IPMNs (mean diameter 4.6 ± 1.7 cm; 80% multilocular) in 25 participants (mean age 74.1 ± 8.3 years) underwent 41 EUS-RFA sessions. AEs occurred in 12.2% of procedures (5/41), the majority being AGREE Grade 3A (9.8%, 4/41).
During a mean follow-up of 18 ± 5 months, 22 of 28 BD-IPMNs (78.6%) achieved ≥ 50% reduction in cyst volume, and 11 (39.3%) demonstrated complete (≥90%) response. Among 26 BD-IPMNs that revealed KRAS GNAS mutations, follow-up NGS was performed in 17, with 88.2% showing loss of detectable mutations.
Conclusions
EUS-RFA in large, predominantly multilocular BD-IPMNs shows promising volumetric efficacy. Safety may be improved through refined energy delivery and technical advances. Molecular response remains exploratory and requires further validation. Long-term studies assessing progression-free outcomes are needed to define its role as an organ-preserving therapeutic option.
Keywords
Endoscopic ultrasonography - Pancreas - Intervention EUS - Endoscopy Upper GI Tract - RFA and ablative methodsPublication History
Received: 04 September 2025
Accepted after revision: 23 December 2025
Accepted Manuscript online:
24 December 2025
Article published online:
21 January 2026
© 2026. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).
Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
Somashekar G. Krishna, Erica Park, Jennifer Rath, Zarine Shah, Ahmed Abdelbaki, Stacey Culp, Fadi Hawa, Dan Jones, Wei Chen, Peter Lee, Hamza Shah, Jordan Burlen, Raj Shah, Mitchell L. Ramsey, Georgios I. Papachristou, Zobeida Cruz-Monserrate, Timothy Pawlik, Mary E Dillhoff, Jordan M. Cloyd, Susan Tsai, Phil A. Hart. Endoscopic ultrasound-guided radiofrequency ablation for large branch-duct intraductal papillary mucinous neoplasms: Safety and efficacy trial. Endosc Int Open 2026; 14: a27788145.
DOI: 10.1055/a-2778-8145
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